Food Safety: Improvements Needed in Overseeing the Safety of Dietary
Supplements and "Functional Foods" (Letter Report, 07/11/2000,
GAO/RCED-00-156).

GAO examined the extent to which agencies' efforts and federal laws
ensure the: (1) safety of functional foods and dietary supplements; and
(2) accuracy of health-related claims on product labels and in
advertising.

GAO noted that: (1) the Food and Drug Administration's (FDA) efforts and
federal laws provide limited assurances of the safety of functional
foods and dietary supplements; (2) while the extent to which unsafe
products reach consumers is unknown, GAO believes weaknesses in three
areas of the regulatory system increase the likelihood of such
occurrences; (3) first, potentially unsafe products may reach consumers
for a variety of reasons, including the lack of a clearly defined safety
standard for new dietary ingredients in dietary supplements; (4) some
products do not have safety-related information on their labels, which
could endanger some consumers; (4) this occurs because FDA has not
issued regulations or guidance on the information required; (5) FDA
cannot effectively assess whether a functional food or dietary
supplement is adversely affecting consumers' health because, among other
things, it does not investigate most reports it receives of health
problems potentially caused by these products; (6) FDA officials
recognize these weaknesses but say a lack of resources has precluded
them from taking actions to correct them; (6) GAO also found that
agencies' efforts and federal laws concerning health-related claims on
product labels and in advertising provide limited assistance to
consumers in making informed choices and do little to protect them
against inaccurate and misleading claims; (7) FDA has not clearly
established the nature and extent of evidence companies need to
adequately support structure/function claims and has taken no actions
against companies making claims that the agency believes to be
questionable; (8) according to a FDA official, the agency has chosen to
use its limited resources on regulating product safety rather than on
taking enforcement actions against problematic label claims; (9)
furthermore, federal agencies operate under different statutes for
regulating claims on product labels and in advertising, which has led to
claims being made in products' advertisements that were not allowed on
product labels; (10) for example, a product that FDA does not allow
claim to lower cholesterol on its label is permitted by the Federal
Trade Commission to make this claim in its advertising, provided the
claim is truthful, not misleading, and supported by reliable scientific
evidence; (11) consumers may not understand the different purposes of
health claims and structure/function claims; and (12) as a result, they
may incorrectly view structure/function claims as claims to reduce the
risk of or treat a disease.

--------------------------- Indexing Terms -----------------------------

 REPORTNUM:  RCED-00-156
     TITLE:  Food Safety: Improvements Needed in Overseeing the Safety
	     of Dietary Supplements and "Functional Foods"
      DATE:  07/11/2000
   SUBJECT:  Product safety
	     Health hazards
	     Safety standards
	     Safety regulation
	     Advertising
	     Consumer protection
	     Labeling law
	     Food and drug law
	     Food industry

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GAO/RCED-00-156

Appendix I: Agencies and Organizations Contacted

34

Appendix II: Comments From the Food and Drug Administration

36

Appendix III: GAO Contacts and Staff Acknowledgments

43

Table 1: Safety-Related Requirements for Functional Foods and Dietary
Supplements 10

Table 2: Claims-Related Requirements for Functional Foods and Dietary
Supplements 11

Table 3: FDA-Authorized Health Claims 19

Figure 1: Historical and Expected Growth in Sales of Functional Foods in the
United States, 1995 to 2010 7

Figure 2: Hypothetical Comparison of Two Products Using the Same
Structure/Function Claim--a Functional Food Without a Disclaimer and a
Dietary Supplement With a Disclaimer 24

DSHEA Dietary Supplement Health and Education Act

FDA Food and Drug Administration

FFDCA Federal Food, Drug, and Cosmetic Act

FTC Federal Trade Commission

GRAS generally recognized as safe

NLEA Nutrition Labeling and Education Act

USDA U.S. Department of Agriculture

Resources, Community, and
Economic Development Division

B-285147

July 11, 2000

Congressional Committees

In 1999, U.S. consumers spent about $31 billion for dietary supplements and
certain food products (termed "functional foods") that claim to have health
benefits beyond basic nutrition. Consumers are expected to spend even more
on these products over the next 10 years. With the increased use of dietary
supplements and functional foods have come questions about whether these
products are safe to use and actually provide the health benefits they
claim.

New, so-called functional foods are entering the market that provide the
basic attributes of traditional foods--taste, aroma, or nutritive value--and
that claim to provide an additional health benefit. For example, recently
marketed butter-like spreads include an added ingredient designed to reduce
cholesterol levels in the bloodstream. In contrast, dietary supplements
generally are available in pill, capsule, tablet, or liquid form; are not
used primarily for their taste or aroma; and cannot be represented as a
conventional food. Supplements include vitamins, minerals, herbs, amino
acids, and other dietary substances that are used to enhance the normal
dietary intake of nutrients or for more specialized purposes, such as
relaxation or stimulation. On their labels,1 both functional foods and
dietary supplements can make health claims and/or so-called
structure/function claims. Health claims state that an ingredient may reduce
the risk of a disease.2 For example, a product containing soy protein can
have a health claim on the label stating that a certain amount of soy
protein every day, as a part of a diet low in saturated fat and cholesterol,

may reduce the risk of heart disease.3 In contrast, structure/function
claims state that an ingredient in the product will benefit a body's
structure (such as the skeletal system) or function (such as the circulatory
system).

The Food and Drug Administration (FDA), under the Federal Food, Drug, and
Cosmetic Act (FFDCA), as amended, is the federal agency primarily
responsible for regulating the safety and claims made in the labeling of
both functional foods and dietary supplements. FDA regulates functional
foods, which have no legal definition or separate regulatory category, under
the rules it applies to conventional foods. These rules require that
ingredients added to the basic food item be either "generally recognized as
safe" (GRAS) or approved by FDA. On the other hand, FDA regulates dietary
supplements under the provisions set out in the Dietary Supplement Health
and Education Act (DSHEA) of 1994, which amended FFDCA and created a new
regulatory category, safety standard, and other rules for supplements. While
FDA regulates product labeling, the Federal Trade Commission (FTC) enforces
consumer protection laws on advertising (including television, radio, the
Internet, and print media) for both functional foods and supplements.
Finally, the U.S. Department of Agriculture (USDA) regulates product label
claims for functional foods containing over a certain percent of meat or
poultry.

To provide the Congress with information about key issues related to
functional foods and dietary supplements, we examined the extent to which
agencies' efforts and federal laws ensure the (1) safety of functional foods
and dietary supplements and (2) accuracy of health-related claims on product
labels and in advertising.

FDA's efforts and federal laws provide limited assurances of the safety of
functional foods and dietary supplements. While the extent to which unsafe
products reach consumers is unknown, we believe weaknesses in three areas of
the regulatory system increase the likelihood of such occurrences. First,
potentially unsafe products may reach consumers for a variety of reasons,
including the lack of a clearly defined safety standard for new dietary
ingredients in dietary supplements. Second, some products do not have
safety-related information on their labels, which could endanger some
consumers. This occurs because FDA has not issued regulations or guidance on
the information required. For example, according to the National Institutes
of Health, St. John's Wort may decrease the efficacy of a drug used to treat
HIV infection, but consumers may not be able to determine this from the
dietary supplement label. Finally, FDA cannot effectively assess whether a
functional food or dietary supplement is adversely affecting consumers'
health because, among other things, it does not investigate most reports it
receives of health problems potentially caused by these products. FDA
officials recognize these weaknesses but say a lack of resources has
precluded them from taking actions to correct them.

We also found that agencies' efforts and federal laws concerning
health-related claims on product labels and in advertising provide limited
assistance to consumers in making informed choices and do little to protect
them against inaccurate and misleading claims. FDA has not clearly
established the nature and extent of evidence companies need to adequately
support structure/function claims and has taken no actions against companies
making claims that the agency believes to be questionable. According to an
FDA official, the agency has chosen to use its limited resources on
regulating product safety rather than on taking enforcement actions against
problematic label claims. Furthermore, federal agencies operate under
different statutes for regulating claims on product labels and in
advertising, which has led to claims being made in products' advertisements
that were not allowed on product labels. For example, a product that FDA
does not allow to claim to lower cholesterol on its label is permitted by
FTC to make this claim in its advertising, provided the claim is truthful,
not misleading, and supported by reliable scientific evidence. Finally,
consumers may not understand the different purposes of health claims and
structure/function claims. As a result, they may incorrectly view
structure/function claims as claims to reduce the risk of or treat a
disease.

We are making recommendations to the Congress and FDA aimed at improving
federal oversight of safety for dietary supplements and functional foods and
at ensuring that these products provide the health benefits they claim on
their labels and in advertising. We provided a draft of the report to FDA,
FTC, and USDA for their review and comment. In commenting on the draft
report, FDA agreed with the need for most of our recommended actions but
disagreed with our recommendation that the agency identify target dates for
taking these actions. We believe, however, that FDA should identify target
completion dates because, among other things, such information will help FDA
and the Congress track FDA's progress in implementing these actions.
Therefore, we did not change our recommendations. FDA did not comment on our
recommendations to the Congress. FDA also made note of various actions it
has already taken and intends to take this fiscal year to address issues
related to functional foods and dietary supplements. FDA, FTC, and USDA
suggested technical clarifications, which we incorporated into the report as
appropriate.

Advances in science have recently allowed companies to begin marketing
functional foods that claim to improve health or reduce the risk of disease
because of substances that have been added. Although the market for
functional foods is relatively new, several different types of products have
emerged. Some traditional foods have been fortified with additional vitamins
or minerals--for example, orange juice has been fortified with calcium and
companies claim this juice will help maintain bone density. Also, existing
dietary supplements, such as echinacea, ginkgo, and ginseng, are being added
to drinks, nutrition bars, and snack foods to provide the various health
benefits attributed to these herbs. Elements in nontraditional food sources
have also been isolated and then added to a traditional food, such as stanol
esters4 used in a butter-like spread to reduce cholesterol. Natural elements
in traditional foods that have health benefits are also being identified.
For example, lycopene5 in tomatoes and isoflavones6 in soybeans may help
protect against various forms of cancer. If scientific research establishes
the safety and benefits of these substances, companies could add them to a
soup, a cereal, or some other food product to create a functional food.

The market for dietary supplements and functional foods is large and could
grow significantly over the next decade. According to industry sources,
consumer sales of supplements increased from $9.8 billion in 1995 to an
estimated $14.7 billion in 1999, while functional food sales increased from
$11.3 billion to an estimated $16.2 billion during the same period. Sales of
functional foods are projected to reach $49 billion by 2010.7 (See fig. 1.)
Several factors account for the projected growth in the market for these
products as well as for supplements: (1) the aging of the baby-boom
generation, (2) an increased interest in self-sufficiency and prevention in
health care, and (3) advances in science that are identifying new
relationships between diet and disease.

Source: Nutrition Business Journal, San Diego.

Under FFDCA, FDA is the federal agency primarily responsible for regulating
the safety of foods, including functional foods and dietary supplements. To
ensure the safety of these products, FDA, among other activities, conducts
plant inspections about once every 5 years, on average. FDA's plant
inspections generally focus on plant sanitation and good manufacturing
practices.

In addition to conducting plant inspections, FDA attempts to ensure that the
ingredients making up a food product are themselves safe for their intended
uses. In this regard, when a company adds an ingredient to a food to change
its color or taste, FFDCA requires that the ingredient either be determined
to be generally recognized as safe by qualified experts or go through FDA's
review and approval process as a food additive. Because there is no legal
definition or separate regulatory category for functional foods, FDA
regulates these products under the rules that apply to foods in general. As
such, if a company adds an ingredient with health benefits beyond basic
nutrition to create a functional food, the company is responsible for
determining that the ingredient meets the GRAS standard or, failing this,
for having it approved as a food additive.

The GRAS standard is defined by regulation as a reasonable certainty in the
minds of competent scientists that the substance is not harmful under its
intended conditions of use. The standard also requires that the data used to
provide evidence of safety be generally available and that a consensus exist
among qualified experts about the safety of the substance for its intended
use. Companies are not required to notify FDA of their GRAS determinations,
although some do so voluntarily.

If a company determines that an ingredient it plans to use in a functional
food is not generally recognized as safe, under FFDCA it must petition FDA
for approval of the ingredient as a food additive. The petition must contain
convincing evidence that the added ingredient meets the safety standard for
food additives, which requires producers to demonstrate to a reasonable
certainty that no harm will result from the intended use of the additive.
Before approving an additive, FDA evaluates the amount of the additive
individuals are likely to consume, the probable long-term effects on them,
and other safety factors. If FDA finds the additive to be safe, the agency
issues a regulation specifying the conditions for safe use. According to
FDA, meeting the safety standard for a food additive requires the same
quantity and quality of scientific evidence as is needed to satisfy the GRAS
standard. The principal difference between the two is that because food
additives are reviewed and approved by FDA, companies do not have to
demonstrate the general recognition element of the GRAS standard.

In contrast, FDA regulates the safety of dietary supplements under the
provisions set out in DSHEA, which amended FFDCA and created a new
regulatory category, safety standard, and other rules for supplements. DSHEA
exempted new dietary ingredients in supplements from the safety requirements
that apply to food additives.8 It stipulated that companies must have a
basis for concluding that a supplement containing a new dietary ingredient
is reasonably expected to be safe under the conditions of use recommended or
suggested in the product's labeling. In addition, DSHEA requires companies
to notify FDA of their evidence for determining the safety of a new dietary
ingredient in a supplement 75 days before marketing the supplement.9 The
companies do not have to obtain FDA's approval of their supplements before
marketing them. Furthermore, DSHEA allows dietary supplements to be marketed
in conventional food form, for example, as a liquid or a bar, as long as
they are labeled as a dietary supplement and not represented as a
conventional food.

Table 1 provides a comparison of the safety-related requirements for
functional food and dietary supplements.

 Safety-related requirements            Functional      Dietary supplements
                                        foods
 An added ingredient must be generally
 recognized as safe by qualified
 experts. If not, the ingredient must   X
 be approved by FDA as a food additive
 before marketing.
 Company must have a basis for
 concluding that a supplement
 containing a "new" dietary ingredient
 is reasonably expected to be safe
 under the conditions of use
 recommended or suggested in the                        X
 product labeling. The new ingredient
 is legally exempted from the
 requirement to be approved as a food
 additive.
 Company must notify FDA regarding the
 basis for concluding a new dietary
 ingredient is safe for its intended                    X
 use at least 75 days before marketing.
 Company required to list on the label
 safety-related information that is
 considered "material" with respect to  X               X
 consequences that may result from the
 use of the product.

FDA is also responsible for ensuring that the product labels for food,
functional foods, and dietary supplements are accurate and not misleading.
In 1990, the Nutrition Labeling and Education Act (NLEA) significantly
changed food labels by allowing them to contain scientifically valid
information regarding the relationship between a food substance and a
disease. In effect, NLEA allows functional foods and dietary supplements to
carry FDA-approved claims, known as health claims, that would otherwise
define the product as a drug under FFDCA. Health claims must be supported by
extensive evidence and are subject to a lengthy and costly FDA review and
authorization process before they can be used on labels. To obtain
authorization for a new health claim, a company must file a petition with
FDA that includes the scientific evidence supporting the proposed claim.10
FDA authorizes the health claim through a rule if, after reviewing the
evidence, it finds "based on the totality of publicly available scientific
evidence" that there is "significant scientific agreement" that the claim is
supported. When FDA authorizes a claim, any company can use it on any
product that meets the nutritional criteria, not just the individual or
company that submitted the petition to FDA. If a food label carries an
unauthorized claim--relating a food substance to the reduced risk,
prevention, or treatment of a disease--FDA considers the product to be an
unapproved new drug and asks the company to change the product label. If the
company refuses, FDA has to take legal action through the courts.

Functional foods and dietary supplements are also allowed to carry label
claims, known as structure/function claims, that describe how consuming the
product will affect the structure or function of the body or a person's
general well-being. For example, echinacea added to a conventional food,
such as tea, to create a functional food may carry a structure/function
claim that the product "supports the body's defense system" as long as there
is evidence to show that the claim is truthful and not misleading. Unlike
health claims, structure/function claims cannot claim to reduce the risk of
disease, and FDA does not validate or authorize them before they can be
used. Table 2 provides a comparison of the claims-related requirements for
functional foods and dietary supplements.

 Claims-related requirements             Functional      Dietary
                                         foods           supplements
 Structure/function claims cannot be
 false or misleading                     X               X
 May use FDA-authorized health claims or
 structure/function claims on product    X               X
 labels
 Must notify FDA within 30 days after
 marketing a product that contains a                     X
 structure/function claim
 Must include a disclaimer on product
 labels that contain structure/function
 claims that states the claim has not                    X
 been evaluated by FDA

While FDA is responsible for regulating the claims made on labels for both
functional foods and dietary supplements, FTC enforces consumer protection
laws regarding the claims made in advertising (including television, radio,
the Internet, and print media) for both of these products. FTC evaluates
claims of health benefits in advertising under the provision of the Federal
Trade Commission Act that prohibits "unfair or deceptive acts or practices"
and any false advertisement that is "misleading in a material respect."
Finally, USDA regulates product label claims for functional foods containing
over a certain percent of meat or poultry.11 These products include, among
others, pot pies, soups, and prepared meals. USDA regulates functional
foods, which have no separate regulatory category, under the rules it
applies to conventional foods.

FDA's efforts and federal laws provide limited assurances that functional
foods and dietary supplements are safe because of weaknesses in three areas.
First, potentially unsafe products may reach consumers for a variety of
reasons, including the lack of a clearly defined safety standard for new
dietary ingredients in dietary supplements. Second, some products do not
have safety-related information on their labels, which could endanger some
consumers. Finally, FDA cannot effectively assess whether a functional food
or dietary supplement is adversely affecting consumers' health because it
may not know the extent of health problems and does not investigate most
reports of health problems believed to be linked to these products.

Reach the Consumer

The laws governing the safety of functional foods and dietary supplements,
as well as FDA's implementation of these laws, may allow products of
questionable safety to reach the market. This can occur in several ways.

First, in the case of functional foods, since FFDCA allows companies to
market a product if they determine that ingredients in it meet the GRAS
standard, these companies do not have to notify FDA before selling the
product to consumers. FDA may only become aware of the product after it
enters the market. This was the case, for example, for several functional
food products containing such herbs as echinacea, ginkgo, and St. John's
Wort. Since these products were already on the market, FDA learned of them
only through complaints from individuals or other companies. FDA notified
these companies that it was unaware of a basis for determining that these
herbs are generally recognized as safe in food. If FDA wanted to remove
these products from the market, and the company did not do so voluntarily,
FDA would have to initiate enforcement actions.

Second, for dietary supplements, FDA has not defined in regulations nor
provided other guidance to companies on the evidence needed to document the
safety of new dietary ingredients in their 75-day pre-market notification.
In the absence of such guidance, companies must make their own best estimate
of how much evidence is adequate to ensure safety. While some supplement
companies may thoroughly evaluate and document the safety of new dietary
ingredients, others may not, which may allow some products with limited
evidence of safety to reach the marketplace, thus endangering the health of
consumers.

Moreover, to remove a dietary supplement containing a new dietary ingredient
from the market, FDA may be required to show in court that the supplement
contains a "new" dietary ingredient for which there is "inadequate
information" to provide "reasonable assurance" the new ingredient does not
present a "significant or unreasonable risk of illness or injury." In the
absence of guidance on the type and amount of evidence to be included in the
pre-market notification to demonstrate safety for new dietary ingredients in
supplements, FDA does not have a clear, consistent standard for identifying
and then pursuing through the courts, the removal of unsafe products. In its
10-year plan to implement DSHEA, issued in January 2000, FDA recognized the
need to develop guidance on the safety substantiation needed in the
pre-market notification for new dietary ingredients in supplements but did
not establish a date for meeting this goal.

Finally, the DSHEA provision that allows supplements to exist in
conventional food form, as, for example, a nutrition bar, has blurred the
boundary between foods and supplements. As a result, some products may be
incorrectly marketed and not held to the standards applicable to them.
Because FDA has not clarified whether the safety standard for new dietary
ingredients in dietary supplements is an equivalent or a lesser standard
than GRAS, some companies may assume that if their product is marketed as a
supplement it will be held to a lower safety standard.

In the course of our review, we encountered several drinks, teas, and other
products, some produced by large companies with national distribution, that
contain herbs, such as St. John's Wort, ginkgo biloba, and echinacea. Some
of these products appear to be functional foods that have been incorrectly
marketed as dietary supplements. In order for these herbs to be legally
marketed in food products, the producers would either have to determine that
they are generally recognized as safe for use in food or have them approved
as food additives. FDA told us that it has not approved these herbs as food
additives and further stated that the agency is unaware of any basis for
concluding that these herbs are generally recognized as safe for use in
food.

The following two examples illustrate the difficulty of determining the
boundary between functional foods and dietary supplements. In 1998 and 1999,
two companies proposed marketing what they believed were dietary supplements
in food form. However, FDA determined that these products were foods, not
supplements. Specifically:

ï¿½ One company proposed marketing a butter-like spread designed to help
control cholesterol as a supplement in food form. Although the prototype
package identified the product as a dietary supplement, the package also
included statements promoting the flavor and texture of the product, along
with pictures of it in uses common for butter or margarine. As a result of
these and other representations, FDA concluded that the product was
represented as a food. The company ultimately marketed its product as a
food, after determining that the added ingredient was generally recognized
as safe; but it informed FDA that it still believed the product could
legally be marketed as a dietary supplement in food form.

ï¿½ Another company marketed a line of soups that contained herbs, such as St.
John's Wort, as dietary supplements. Again, FDA concluded that even though
the product was labeled as a dietary supplement, it was represented as a
food because of references on the label to traditional soup ingredients and
taste characteristics. Although the company told FDA it believed the soups
were in fact dietary supplements, the company chose to discontinue marketing
them.

FDA's actions regarding the butter-like spread and the line of soups have
established regulatory precedents, but the agency has not issued policy
guidance to clarify the circumstances under which it believes that
supplements can legitimately be marketed in food form. Several companies
told us they need clarity on this issue to guide them in the development and
marketing of their products. For example, one company told us that FDA needs
a more transparent policy on what constitutes representation as a food so
that companies know when it is appropriate to market a product in food form
as a dietary supplement.

In addition, some groups have questioned the justification for having
different safety standards for dietary supplements and functional foods. For
example, according to the Research-based Dietary Ingredient Association,
which represents a group of large food and supplement companies, "there is
no scientific reason to support different standards of safety for foods and
dietary supplements, even though the approval processes are different by
statute."12 The Association believes that "the same ingredient, whether it
goes into a dietary supplement or food should meet the same standard of
safety."13 Similar sentiments regarding the desirability of a single safety
standard have been expressed by representatives of the American Dietetic
Association, which represents nutrition professionals, and the Center for
Science in the Public Interest, which represents consumer interests.

FDA recognizes that the definitional boundary between functional foods and
dietary supplements is not clear. In its 10-year plan to implement DSHEA,
issued in January 2000, the agency identified the need to clarify the
boundary between conventional foods, including functional foods, and dietary
supplements; however, the plan does not state when or how the agency will
address this issue.

on the Safety-Related Information Required on the Labels of Supplements and
Functional Foods

FDA has not developed regulations or provided guidance to companies on the
type of safety-related information that should be included on their labels
for functional foods and dietary supplements. The absence of such safety
information poses a significant safety risk to some consumers. For example,
research by the National Institutes of Health, published in February 2000,
showed that St. John's Wort may decrease the effectiveness of a drug used to
treat HIV infection. This finding prompted FDA to issue a public health
advisory to health care professionals on the dangers of using the drug and
the supplement at the same time. Nevertheless, FDA did not require companies
that produce products containing St. John's Wort to warn consumers of this
interaction on product labels.

FDA could issue regulations requiring such information. FFDCA requires
dietary supplements and functional foods to disclose "facts that are
material in the light of representations made about the product or with
respect to consequences that may result from the use of the product."
However, FDA has not prescribed by regulation or clarified in guidance what
information is "material" or provided guidance on when or if certain
safety-related information should be included on labels, such as information
on the maximum safe dosage of the ingredients in the product, possible
interactions between the ingredients and drugs, or the need for certain
groups, such as pregnant women, to avoid ingesting them. As a result, some
producers of dietary supplements and functional foods are not including
important safety information in their labeling.

Functional Foods and Dietary Supplements and Does Not Fully Evaluate
Reported Problems

Once functional foods and dietary supplements are marketed, FDA becomes
aware of health problems potentially associated with these products only
when consumers, health professionals, or others contact FDA to alert the
agency. Since 1993, FDA has received 2,797 reports of adverse effects,
including 105 deaths, potentially associated with dietary supplements.14
Supplements containing ephedrine alkaloids, which are promoted for such
effects as losing weight and increasing energy levels, have accounted for
about 1,173 reports of adverse effects, more than any other type of dietary
supplement. As of February 29, 2000, FDA had not received any reports of
health problems associated with functional foods, although the herbs most
frequently associated with adverse reactions in supplements, according to a
1999 nationwide consumer survey--ginseng, St. John's Wort, echinacea, and
ginkgo--have begun to appear in functional foods and beverages.15

FDA's count of reported adverse effects from dietary supplements is at odds
with other information. The 1999 nationwide consumer survey found that 12
percent of all consumers who have used an herbal dietary supplement, about
11.9 million people, said that they had experienced an adverse reaction.

The lower number of adverse events received by FDA is not surprising, given
the limitations of FDA's adverse event monitoring systems for both
functional foods and supplements. These are voluntary reporting systems,
which, as we reported in 1999, have serious limitations.16 For instance, in
voluntary reporting systems, the number of health problems is significantly
underreported, and the reports do not have to follow a standard format and
may be incomplete.

Even if FDA had a better system for capturing adverse events, it would not
necessarily know whether these reports justified taking action. Reports of
health problems are subjective, so a causal connection between the observed
event and a particular product cannot be assumed. Such reports need to be
analyzed to identify the potential magnitude of the problem and investigated
to clearly establish a link between an adverse event and a product or
ingredient.

According to FDA officials, the computer system they use to monitor reports
of health problems associated with dietary supplements is severely limited
in its ability to effectively track and analyze these reports. FDA cannot,
for example, use the computer system to identify trends in the data and must
therefore conduct such analyses manually. FDA recognizes the limitations of
this system and has sought funds from the Congress, so far unsuccessfully,
to improve its systems for tracking adverse events.

Furthermore, FDA officials told us that only three staff are available
part-time to investigate reports of health problems associated with dietary
supplements. According to FDA officials, the agency conducts a preliminary
screening of all the reports related to supplements to identify the most
significant ones, such as those resulting in death or disability. However,
resource limitations allow them to perform detailed reviews of only some of
the most significant reports, or less than 40 percent of the total reported
health problems. For example, the reports for St. John's Wort include
problems such as difficulty breathing, throat constriction, headaches,
dizziness, convulsions, rash, and vomiting. Yet FDA officials told us that a
lack of resources precluded them from taking any action to investigate these
reports beyond the preliminary screening. Without further investigation, FDA
cannot know why these health problems occurred, whether they were in fact
caused by St. John's Wort, or whether FDA should take any action to protect
the public's safety.

Protection Against Inaccurate or Misleading Health-Related Claims

Agencies' efforts and federal laws concerning health-related claims on
product labels and in advertising provide limited assistance to consumers in
making informed choices and do little to protect them against inaccurate and
misleading claims. First, FDA has not clearly established the nature and
extent of the evidence companies need to adequately support
structure/function claims and has taken no actions in court against
questionable claims. Second, federal agencies operate under different
statutes for regulating claims on product labels and in advertising, which
has led to advertising claims that are not allowed on product labels.
Finally, consumers may not understand the different purposes of health and
structure/function claims. Consequently, they may incorrectly view
structure/function claims as claims to reduce the risk of or treat a
disease, rather than their more limited purpose of describing how consuming
a product affects a structure or function of the body (such as the
circulatory system) or a person's general well-being.

Structure/Function Claims and Takes No Action Against Questionable
Structure/Function Claims

Under FFDCA, both health claims and structure/function claims can be used on
the labels of functional foods and dietary supplements. While FDA has
evidentiary standards for health claims, it has not clearly defined its
standards for structure/function claims. Furthermore, it has taken no
enforcement actions against questionable structure/function claims.

Health claims

Health claims state that an ingredient or product may reduce the risk of a
disease. Before a health claim for an ingredient or a product can be used,
it must go through a rigorous FDA review of the scientific evidence
supporting the claim. As of March 2000, FDA had authorized 11 generic health
claims for use on functional foods or dietary supplements. (See table 3.)
For example, products that are low in sodium can claim they may reduce the
risk of high blood pressure, and products that are low in fat, saturated
fat, and cholesterol can claim they may reduce the risk of heart disease.
Health claims are primarily used on food product labels; only four of the
authorized health claims--for calcium, folic acid, psyllium husk, and soy
protein--apply to substances that are available as dietary supplements.

 Health claims                          Attribute of food or supplement
 Helps maintain healthy bones and may
 reduce risk of osteoporosis            High in calcium
 May reduce risk of high blood pressure Low in sodium
 May reduce risk of some cancers        Low in fat

 May reduce risk of heart disease       Low in saturated fat and
                                        cholesterol

 May reduce risk of some cancers        Fiber containing fruits,
                                        vegetables, and grain products

 May reduce risk of heart disease       Fiber containing fruits,
                                        vegetables, and grain products
 May reduce risk of some cancers        Fruit or vegetable
 May reduce risk of brain and spinal
 cord birth defects                     Supplying folic acid
 May reduce risk of tooth decay         Uses dietary sugar alcohols

 May reduce risk of heart disease       Contains soluble fiber from whole
                                        oats or psyllium husk
 May reduce risk of heart disease       Contains soy protein

Note: The table is a simplified presentation of the dietary attributes and
health effects associated with authorized health claims. The product may
have to contain additional food attributes, and the company may have to
provide additional information in the claim for the claim to be permitted.

Structure/function claims

Structure/function claims describe how consuming the product will affect a
structure (such as the skeletal system) or function (such as the circulatory
system) or a person's general well-being but do not claim to reduce the risk
of, prevent, or treat a disease. For example, structure/function claims
state that the product "supports the immune system" or "helps support
cartilage and joint function."

While FDA has established evidentiary requirements for health claims, it has
not done so for structure/function claims. Under FFDCA, structure/function
claims on functional foods and dietary supplements cannot be false or
misleading. However, the law does not define the nature or extent of the
evidence necessary to adequately support structure/function claims, and FDA
has not provided detailed guidance to industry on what constitutes
appropriate documentation. FDA recognized the need for guidance on the
evidence needed to support structure/function claims in its 10-year plan to
implement DSHEA; however, the plan does not state when or how the agency
will address this issue.

Furthermore, the evidence available to support structure/function claims
varies widely because some ingredients have been thoroughly studied while
others have not. For example, there is strong evidence in the medical
literature that St. John' s Wort can be useful in treating mild depression.
On the other hand, according to BioValidity, the publisher of an on-line
encyclopedia that grades the quantity and quality of scientific research
available to support benefit statements for over 200 vitamin, mineral, and
herb supplements, there is little evidence available to support many claims
that are made. According to BioValidity, there is only minimal evidence that
ginseng may help to overcome fatigue, but such claims are made. In addition,
some structure/function claims, for example, "cleanses the blood," are so
vague or general that they have little or no scientific meaning and would be
very difficult to prove.

Companies have recognized the need for guidance on the evidentiary
requirements for structure/function claims. For example, during the 1996-97
public hearings held by the Commission on Dietary Supplement Labels,17
several manufacturers asked the Commission to clarify the type of
information needed to substantiate structure/function claims.

Enforcement

While NLEA requires FDA to rigorously review health claims before
authorizing their use on product labels, there are no such requirements for
structure/function claims before they are used on product labels. For
dietary supplements, however, DSHEA requires companies to notify FDA of
their products' structure/function claims within 30 days after marketing the
product. FDA reviews these notifications to determine that the claim is
actually a structure/function claim and not a claim to reduce the risk of,
prevent, or treat a disease. FDA does not have a similar mechanism for
identifying whether structure/function label claims for functional foods are
actually unauthorized disease-related claims because FFDCA does not require
makers of these products to notify FDA regarding the structure/function
claims they are making.

For example, if FDA determines that a dietary supplement label
inappropriately claims to treat, prevent, or reduce the risk of disease, it
issues a letter to the company objecting to the claim. As of January 6,
2000, according to FDA, the agency had received and reviewed about 5,200
notifications of structure/function claims on dietary supplement labels and
had sent out 336 letters objecting to the proposed claims.

However, according to FDA officials, the agency's review of dietary
supplement labels does not address whether the company has adequate evidence
to support the structure function claim in the first place. Concerns have
been raised that because of the limited amount of available research, some
structure/function claims on products in the marketplace are not supported
by adequate scientific evidence. In addition, both food and dietary
supplement industry associations have said they believe it is important for
FDA to take enforcement actions against unsupported claims. Nonetheless, FDA
has never asked a company marketing dietary supplements or functional foods
with structure/function claims to voluntarily provide the agency with the
evidence supporting the claim, nor has FDA ever initiated an enforcement
action to obtain access to the information through the courts. According to
FDA, one of its priorities for fiscal year 2000 is to develop effective
enforcement procedures to respond to significant or precedent-setting
discrepancies in food labeling, including trade complaints.

Claims on Product Labels and in Advertising

Three different federal agencies--FDA, FTC, and USDA--share responsibility
for determining which health claims are allowed in labeling and in
advertising for functional foods and dietary supplements. Because these
agencies enforce different laws, a product's claims of health benefits might
be allowed by one agency but denied by another.

FDA and FTC have different legislative standards for approving claims:

ï¿½ FDA-authorized health claims are "based on the totality of publicly
available scientific evidence" that there is "significant scientific
agreement" that the claim is supported, as authorized under the Nutrition
Labeling and Education Act of 1990.

ï¿½ Advertising claims of health benefits are subject to the provision of the
Federal Trade Commission Act that prohibits "unfair or deceptive acts or
practices" and any false advertisement that is "misleading in a material
respect."

FTC attempts to harmonize its enforcement of claims in advertising to the
extent possible with FDA's enforcement of label claims. However, FTC
recognizes that because it and FDA are charged with enforcing different
laws, there are certain situations in which a qualified health claim is
allowed in advertising, even though FDA has not authorized the claim. For
example, FDA currently does not allow functional foods or dietary
supplements containing stanol esters to carry labels that make claims to
lower cholesterol. However, these products are permitted to make this claim
in their advertising as long as the claim is truthful and not misleading and
is supported by competent and reliable scientific evidence.

Some groups have raised concerns about the difference in the types of health
claims FDA and FTC allow, while others believe the differences are
appropriate. The Center for Science in the Public Interest, a group
representing consumer interests, believes that food advertising and labeling
claims should be treated consistently so that only FDA-authorized health
claims would be permitted in advertising. In contrast, some industry groups
we spoke to found FDA's approach to authorizing health claims overly
restricts what companies are allowed to say and, given FTC's legal mandate,
believed that it was appropriate for FTC to take a different approach to
claims made in advertising.

A recent court decision may result in changes to FDA's current approach to
authorizing health claims in labeling.18 In 1994, a lawsuit was filed
against FDA charging that the agency had inappropriately denied several
health claims petitions. In this lawsuit, the plaintiffs argued that the
health claims should be authorized even if in FDA's view they did not meet
the standard of "significant scientific agreement" as long as they could be
made truthful and not misleading with the addition of a disclaimer. In
January 1999, the U.S. Court of Appeals for the District of Columbia decided
in favor of the plaintiffs and ordered FDA to reconsider the health claim
petitions after the agency better defined the standard of "significant
scientific agreement" and evaluated the use of disclaimers in creating
truthful health claims. FDA is currently in the process of reexamining the
proposed health claims in response to the court's instructions.

While FDA has authorized 11 generic health claims, USDA has not issued
regulations to adopt these claims for use on the products it regulates, such
as pot pies, soups, and prepared meals containing over a certain percent of
meat or poultry. According to a USDA official, the Department reviews
requests to use a health claim on a case-by-case basis. For example, FDA
recently authorized a health claim that soy protein may reduce the risk of
heart disease, but even if a USDA-regulated product contains enough soy
protein to qualify for the claim, the claim could only be used if a company
asked USDA to review and approve it. According to an official of the
National Food Processors Association, USDA should develop a comprehensive
approach to the use of health claims on products containing meat or poultry
rather than regulate on a case-by-case basis.

Are Not Apparent to Consumers and Can Lead to Possible Misuse

According to preliminary FDA research, consumers do not understand the
intended differences in meaning between health claims and structure/function
claims. As a result, they may incorrectly view structure/function claims as
claims to reduce the risk of or treat a disease.

In August 1999, FDA conducted nine focus groups on dietary supplement
labeling in three cities around the country. Among other things, this
research found, "there was no indication that participants differentiated at
all between structure/function claims and health claims." In addition, FDA
received comments on its proposed rule on structure/function claims from
dietary supplement manufacturers, consumer groups, health professional
groups, and others stating that the distinction between health and
structure/function claims is artificial and that consumers view both types
of claims as disease treatment or prevention claims. As such, consumers
incorrectly view claims to maintain health (structure/function claims) as
claims to reduce the risk of, or treat a disease. Consequently, we believe
that consumers may attempt to treat a disease with a product not capable of
producing this benefit.

To help consumers make informed choices, DSHEA mandates that companies using
structure/function claims on dietary supplements include the following
disclaimer on the label regarding the claim: "This statement has not been
evaluated by the Food and Drug Administration. This product is not intended
to diagnose, treat, cure or prevent any disease."

However, this disclaimer requirement does not exist for functional foods
that carry structure/function claims, even if the same ingredient is the
basis of the label claim. For example, a dietary supplement that uses a
structure/function claim related to maintaining a healthy circulatory system
would have to include the disclaimer on its label, but a functional food
containing the same ingredient and claim would not. (See fig. 2.)

In enacting DSHEA, the Congress recognized that providing information to
consumers on labels or by other means was important in helping them make
informed and appropriate health care choices for themselves and their
families. Studies of consumers' understanding of label claims on foods and
supplements, however, have shown that consumers may not fully understand the
information they receive. The Commission on Dietary Supplement Labels also
recognized "the potential for miscommunication despite the efforts of policy
makers to establish clear labeling guidelines and of manufacturers to comply
with them."19 As such, given the significance of consumer understanding of
label claims and the potential for miscommunication, the Commission urged
that consumers' understanding of structure/function and health claims
receive continued assessment. In this regard, FDA officials said that if a
panel is established to further assess labeling issues, it should be
independent of FDA because the agency may not be viewed by some as an
independent arbiter.

Consumers' continuing interest in preventive health care means the
consumption of dietary ingredients with health benefits beyond basic
nutrition is likely to increase, whether in the form of functional foods or
dietary supplements. However, along with this increased consumption,
consumers face health risks because current federal laws and agencies'
efforts do not effectively and consistently ensure that these products are
safe. Furthermore, consumers do not consistently receive clear,
scientifically supported information concerning products' health benefits so
they can make informed dietary choices. While we cannot estimate the extent
to which unsafe products reach the market, we believe that weaknesses in the
regulatory system increase the likelihood of such occurrences. In this
regard, since 1993, FDA has received 2,797 reports of adverse effects,
including 105 deaths, associated with dietary supplements.

More particularly, there are weaknesses in the current measures for ensuring
safety before products are marketed and for monitoring the hazards of
products already on the market. The lack of a safety notification
requirement for functional foods limits FDA's ability to review safety
evidence before these products arrive on grocery shelves. At the same time,
FDA has not developed and promulgated regulations or guidance on the amount
and type of evidence needed to demonstrate the safety of new dietary
ingredients in dietary supplements. Finally, the boundary between functional
foods and dietary supplements is not clear. As a result, unsafe products
could come to market because companies did not develop a sufficient level of
evidence on their safety. Once products reach consumers, FDA lacks an
effective system to track and analyze instances of adverse effects. Until it
has one, consumers face increased risks because the nature, magnitude, and
significance of safety problems related to consuming dietary supplements and
functional foods will remain unknown.

Meanwhile, consumers are faced with a confusing array of claims--some that
require rigorous scientific support and others that can be made with less
evidence--with no clear way to distinguish between them. Even when products
have made what some believe to be unsupported structure/function claims, FDA
has taken no enforcement action. As a result, consumers may make
inappropriate dietary choices and rely on ineffective products to treat
their health problems. In addition, the absence of notification requirements
for functional foods making structure/function claims limits FDA's ability
to identify inappropriate claims. At the same time, the absence of
disclaimer requirements for structure/function claims on functional foods
limits consumers' ability to distinguish FDA-authorized claims from other
claims that have not been reviewed and authorized. While near-term actions
can be taken to help ensure that structure/function claims are accurate and
not misleading, a longer-term independent review is needed to determine
whether the fundamental differences between these claims and health claims
can be made clear to consumers.

To help ensure that functional foods and dietary supplements are safe and
that consumers receive accurate information about them, we recommend that
the Congress

ï¿½ amend the Federal Food, Drug, and Cosmetic Act to require makers of
functional foods to meet the same requirements that currently apply to
dietary supplements: (1) advance notification to FDA regarding ingredients
that companies have determined are safe, (2) notification to FDA regarding
the use of structure/function claims, and (3) disclaimers of FDA approval on
product labels containing structure/function claims.

ï¿½ establish an expert panel to reexamine the current approach to labeling,
which distinguishes health claims from structure/function claims, to
determine whether the intended distinctions can be made clear and meaningful
to consumers, or failing this, to identify other changes needed to improve
consumers' understanding of health-related claims.

While FDA has recognized in its 10-year plan to implement the Dietary
Supplement Health and Education Act the need for many of the actions we are
recommending, the agency has not stated when or how it will address these
issues. Therefore, to help ensure that functional foods and dietary
supplements are safe and that consumers receive accurate information about
them, we recommend that the Commissioner of FDA establish firm time frames
in its plan and take other necessary steps to

ï¿½ develop and promulgate regulations or other guidance for industry on the
evidence needed to document the safety of new dietary ingredients in dietary
supplements;

ï¿½ clarify the boundary between conventional foods, including functional
foods, and dietary supplements, particularly the circumstances under which
dietary supplements may be marketed in food form;

ï¿½ develop and promulgate regulations or other guidance for industry on the
safety-related information required on labels for dietary supplements and
functional foods;

ï¿½ develop an enhanced system to record and analyze reports of health
problems associated with functional foods and dietary supplements;

ï¿½ develop and promulgate regulations or other guidance for industry on the
evidence needed to support structure/function claims; and

ï¿½ develop and implement a strategy for identifying and taking appropriate
enforcement actions against companies marketing products with unsupported
structure/function claims on their labels.

We provided FDA, FTC, and USDA with a draft of this report for their review
and comment. FDA welcomed the report as a means of calling attention to the
challenges it faces in regulating functional foods and dietary supplements.
However, FDA believed that the report should note that it has already begun
taking steps to implement the 10-year Dietary Supplement Strategic Plan and
cited several specific enforcement and other activities targeted for
completion by the end of this fiscal year. While FDA's planned actions
targeted for this fiscal year appear worthwhile, only one of the actions is
directly related to the issues we raised in the report. As such, we revised
the report to note that in fiscal year 2000, FDA intends to develop
effective enforcement procedures to respond to significant or
precedent-setting food labeling problems. We believe the other actions FDA
cited, such as alerting the public to potentially unsafe dietary supplements
and attempting to enhance the adverse event reporting system, are positive
but do not warrant modifying the report.

FDA generally agreed with the need for the report's recommended actions but
did not comment on our recommendations to the Congress. Specifically, FDA
said that all but one of the recommended actions were included in its
10-year Dietary Supplement Strategic Plan and that it will add the remaining
recommended action--to develop guidance for industry on the safety-related
information required on product labels--to the plan next year. However, FDA
did not agree with the report's recommendation that it should establish firm
time frames for all of the activities in its plan. FDA said resource
limitations prevented it from setting such time frames. Rather, FDA will
provide details on when and how a given item in the plan will be
accomplished in the fiscal year that resources become available to take
action. FDA believes that because of the potentially long lead time before
some of the less significant items can be addressed, the agency's limited
resources would be better spent in working on current priority concerns
rather than in long-range planning. We understand FDA's desire to focus on
current priority concerns. Nonetheless, we believe that FDA should provide
more detail, as well as target completion dates, for the actions outlined in
its 10-year Dietary Supplement Strategic Plan. Such information will help
clarify for the Congress and other interested parties the nature and extent
of FDA's planned actions, as well as their priority in relation to other
planned activities, and aid in tracking FDA's progress toward implementing
its plans. In addition, this information would be useful to the Congress in
making decisions regarding future FDA appropriations.

FDA, FTC, and USDA also provided technical clarifications, which we
incorporated into the report as appropriate. FDA's comments and our
responses are appendix II.

To determine the extent to which federal laws and agency efforts ensure the
safety of functional foods and dietary supplements, we reviewed the safety
provisions for dietary supplements contained in the Dietary Supplement
Health and Education Act of 1994. We also reviewed the safety provision for
food and food additives contained in the Federal Food, Drug, and Cosmetic
Act, as amended. In addition, we reviewed FDA regulations implementing the
safety provisions of these laws as well as FDA's proposed regulations
regarding the safety of supplements. Besides reviewing the laws and
regulations, we interviewed representatives of, and obtained documents from,
a wide variety of organizations regarding safety concerns related to
functional foods and dietary supplements. These organizations included (1)
FDA; (2) food companies, including Nestle USA, Lipton, and Kellogg; (3) two
major food industry associations--the Grocery Manufacturers of America and
the National Food Processors Association; (4) dietary supplement industry
associations, including the Council for Responsible Nutrition and the
National Nutritional Foods Association; (5) the Center for Science in the
Public Interest, a consumer group; (6) the American Dietetic Association, a
nutrition group; and (7) academic institutions, including the Nutraceutical
Institute at Rutgers University. See appendix I for a complete list of the
organizations we spoke with.

To determine the extent to which federal laws and federal agencies' efforts
ensure the accuracy of health-related claims on product labels and in
advertising, we reviewed the health-related claims provisions of DSHEA; the
FDA Modernization Act of 1997; the Federal Food, Drug, and Cosmetic Act, as
amended; and the Federal Trade Commission Act. In addition, we reviewed
FDA's proposed and final regulations regarding health-related label claims
and FTC's guidance to industry on advertising for foods and dietary
supplements. Furthermore, we interviewed representatives of, and obtained
documents regarding labeling and advertising concerns related to functional
foods and dietary supplements from, FDA, FTC, USDA, and the food companies,
food and dietary supplement industry associations, consumer and nutrition
groups, and academic institutions listed above, among others.

We conducted our review from July 1999 through June 2000 in accordance with
generally accepted government auditing standards.

We will send copies of this report to the congressional committees with
jurisdiction over the safety and labeling of foods and dietary supplements;
the Honorable Dan Glickman, Secretary of Agriculture; the Honorable Jane
Henney, Commissioner of the Food and Drug Administration; the Honorable
Robert Pitofsky, Chairman of the Federal Trade Commission; and other
interested parties. We will also make copies available to others on request.

If you have any questions about this report, please contact me at (202)
512-5138 or Keith Oleson at (415 ) 904-2218. Key contributors to this report
are listed in appendix III.

Sincerely yours,
Lawrence J. Dyckman
Director, Food and Agriculture Issues

List of Committees

The Honorable Richard G. Lugar
Chairman
The Honorable Tom Harkin
Ranking Minority Member
Committee on Agriculture, Nutrition,
and Forestry
United States Senate

The Honorable Thad Cochran
Chairman
The Honorable Herb Kohl
Ranking Minority Member
Subcommittee on Agriculture, Rural
Development and Related Agencies
Committee on Appropriations
United States Senate

The Honorable John McCain
Chairman
The Honorable Ernest F. Hollings
Ranking Minority Member
Committee on Commerce, Science, and Transportation
United States Senate

The Honorable James M. Jeffords
Chairman
The Honorable Edward M. Kennedy
Ranking Minority Member
Committee on Health, Education, Labor, and Pensions
United States Senate

The Honorable Larry Combest
Chairman
The Honorable Charles W. Stenholm
Ranking Minority Member
Committee on Agriculture
House of Representatives

The Honorable Joe Skeen
Chairman
The Honorable Marcy Kaptur
Ranking Minority Member
Subcommittee on Agriculture,
Rural Development, Food and
Drug Administration, and Related
Agencies
Committee on Appropriations
House of Representatives

The Honorable Tom Bliley
Chairman
The Honorable John D. Dingell
Ranking Minority Member
Committee on Commerce
House of Representatives

Agencies and Organizations Contacted

Federal Agencies

Food and Drug Administration
U.S. Department of Agriculture
Federal Trade Commission
National Institutes of Health, Office of Dietary Supplements

State Agency
California Department of Health Services, Food and Drug Branch

Food Industry Associations
Grocery Manufactures of America
National Food Processors Association
Research-based Dietary Ingredient Association

Food Companies

Archer Daniels Midland Company
Kellogg Company
Lipton
McNeil Consumer Healthcare
Nestle USA
Protein Technologies International
The Hain Food Group

Dietary Supplement Associations

Council for Responsible Nutrition
Consumer Healthcare Products Association
National Nutritional Foods Association

Nutrition Groups

American Dietetic Association
International Food Information Council

Consumer Group

Center for Science in the Public Interest

Academia

University of Illinois, Functional Foods for Health Program
Rutgers University, The Nutraceuticals Institute
University of California, Berkeley, Nutrition Sciences Department

Comments From the Food and Drug Administration

1. We support the Food and Drug Administration's (FDA) plans to take
enforcement actions against unsafe dietary supplements. However, because the
draft report did not raise concerns about this issue, we did not revise the
report to reflect FDA's planned actions. The draft report does raise
concerns about the lack of enforcement actions against unsupported claims in
product labeling. Therefore, we revised the draft report to note that in
fiscal year 2000 FDA intends to develop effective enforcement procedures to
respond to significant or precedent-setting discrepancies in food labeling.

2. FDA did not specify the nature of the additional activities related to
conventional foods, including functional foods, and dietary supplements the
agency plans to complete by the end of this fiscal year. However, we
reviewed the activities listed in FDA's Center for Food Safety and Applied
Nutrition 2000 Program Priorities and found that they do not relate directly
to the issues raised in our draft report. Therefore, we did not revise the
report to reflect FDA's planned actions. Furthermore, while we support FDA's
efforts to develop a scientific and regulatory framework for
structure/function claims for conventional foods, we continue to believe
that a broader review of health and structure/function claims for both
functional foods and dietary supplements is needed to help ensure that
consumers receive accurate information about these products.

3. We support the actions FDA has taken to alert the public to potential
safety problems associated with products marketed as dietary supplements.
However, we continue to believe that the additional actions we have
recommended--for example, developing guidance for industry on (1) the
evidence needed to document the safety of new dietary ingredients and (2)
the safety-related information required on labels--are needed to help ensure
the safety of functional foods and dietary supplements.

4. We recognize that FDA has recently completed an extensive risk assessment
for ephedrine alkaloids and has taken other actions to improve its ability
to track and evaluate reports of adverse events related to functional foods
and dietary supplements. While FDA's comments provide additional details
about the agency's activities in this area, we do not believe this
information warrants changing the draft report. In addition, we still
believe that the absence of an effective system to analyze reports of health
problems associated with functional foods and dietary supplements continues
to hamper FDA's ability to clearly establish links between an adverse event
and a product and to take action to protect public safety.

5. We continue to believe that FDA should provide more detail as well as
target completion dates for the actions outlined in its 10-year Dietary
Supplement Strategic Plan. This information will help clarify for the
Congress and other interested parties the nature and extent of FDA's planned
actions as well as their priority in relation to other planned activities
and aid in tracking FDA's progress toward implementing its plans. In
addition, we believe this information would be useful to the Congress in
making decisions regarding future FDA appropriations.

GAO Contacts and Staff Acknowledgments

Lawerence J. Dyckman, (202) 512-5138
Keith W. Oleson, (415) 904-2218

In addition to those named above, Stephen D. Secrist, Roderick T. Moore,
John M. Nicholson Jr., Jonathan M. Silverman, and Carol Herrnstadt Shulman
made key contributions to this report.

(150145)

Table 1: Safety-Related Requirements for Functional Foods and Dietary
Supplements 10

Table 2: Claims-Related Requirements for Functional Foods and Dietary
Supplements 11

Table 3: FDA-Authorized Health Claims 19

Figure 1: Historical and Expected Growth in Sales of Functional Foods in the
United States, 1995 to 2010 7

Figure 2: Hypothetical Comparison of Two Products Using the Same
Structure/Function Claim--a Functional Food Without a Disclaimer and a
Dietary Supplement With a Disclaimer 24
  

1. In this report, we use the terms "label" and "labeling" interchangeably
to describe the written, printed, or graphic matter on any article, its
containers or wrappers, or accompanying material.

2. Currently, the Food and Drug Administration has only authorized health
claims that claim to reduce the risk of a disease. However, the issue of
whether health claims can include claims to treat or mitigate disease is now
being litigated in Whitaker v. Shalala , No. 1:99cv03247, (D.D.C., filed
Dec. 7, 1999).

3. To qualify for using the health claim for soy protein, the product must
meet certain nutritional requirements such as, among others, one 8 ounce
serving of the product must contain at least 6.25 grams of soy protein.

4. Stanol esters are derived from plant extracts and work as part of the
digestive process to help block the absorption of cholesterol.

5. Lycopene is the chemical compound primarily responsible for the red color
in tomatoes and is being studied for its role in cancer risk reduction.

6. Isoflavones are compounds that bind to estrogen receptors and block
estrogen activity in cells, potentially reducing the risk of breast and
ovarian cancer.

7. These figures come from the Nutrition Business Journal, which provides
strategic information to decisionmakers in the nutrition industry.

8. Under FFDCA, as amended, any ingredient added to a food is subject to the
safety requirements for foods. DSHEA established safety provisions for "new"
dietary ingredients in dietary supplements, defined as those that had not
been marketed as dietary supplements for use in the United States prior to
Oct. 15, 1994. The concept of a "new" ingredient, as defined in DSHEA, does
not exist for foods.

9. No notification is required if the new dietary ingredient has been
"present in the food supply as an article used for food in a form in which
the food has not been chemically altered."

10. The FDA Modernization Act of 1997 contained a provision that permits
companies to use health claims on food products if the claims are based on
current, published, authoritative statements from certain federal scientific
bodies, as well as from the National Academy of Sciences. In lieu of a
petition, a company submits a notification to FDA regarding the claim. If
neither FDA nor a federal district court objects, the claim may be used 120
days after it is submitted. The intent of this provision was to allow some
claims to be authorized more quickly than under the process originally
established in the NLEA. FDA has proposed but not yet issued final
regulations to expand this provision to supplements.

11. USDA is responsible for regulating food products containing 2 percent or
more cooked or 3 percent or more raw meat or poultry.

12. The members of the Research-based Dietary Ingredient Association include
Cargill, Galagen, General Nutrition, Monsanto, and Novartis.

13. Comments dated May 7, 1999, submitted to FDA Docket No. 99N-0554.

14. According to FDA, about 40 to 50 of the reports in its database were
received prior to 1993.

15. The 1999 Prevention Magazine National Survey of Consumer Use of Dietary
Supplements (Rodale, Inc., Feb. 2000).

16. Dietary Supplements: Uncertainties in Analyses Underlying FDA's Proposed
Rule on Ephedrine Alkaloids ( GAO/HEHS/GGD-99-90, July 2, 1999).

17. The Commission on Dietary Supplement Labels was established by DSHEA to
develop recommendations for regulating label claims on supplements and was
made up of seven presidential appointees with expertise and experience in
the manufacture, regulation, distribution, and use of supplements. The
Commission completed its duties with the issuance of its 1997 report.

18. Pearson v. Shalala , 164 F. 3d 650 (D.C. Cir. 1999), reh'g en banc
denied , 172 F. 3d 72 (D.C. Cir. 1999).

19. Report of the Commission on Dietary Supplement Labels (Commission on
Dietary Supplement Labels, November 1997).
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