[Federal Register Volume 61, Number 78 (Monday, April 22, 1996)]
[Notices]
[Pages 17706-17708]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-9780]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food And Drug Administration
[Docket No. 95N-0308]


Inapplicability of the Dietary Supplement Health and Education 
Act to Animal Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is providing guidance 
regarding the inapplicability of the Dietary Supplement Health and 
Education Act of 1994 (the DSHEA) to products intended for use in 
animals. The agency is issuing this notice in response to inquiries 
received on whether the DSHEA applies to products intended for use in 
animals.

DATES: Submit written comments by July 22, 1996.

ADDRESSES: Written comments may be submitted to the Dockets Management 
Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 
1-23, Rockville, MD 20857. Comments should be identified with the 
docket number found in brackets in the heading of this document. 
Received comments may be seen at the Dockets Management Branch (address 
above) between 9 a.m. and 4 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Donny Dean, Center for Veterinary 
Medicine (HFV-236), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-594-1726.

SUPPLEMENTARY INFORMATION: FDA has had inquiries concerning whether the 
DSHEA applies to products intended for use in animals. After examining 
the statutory language, intent, and legislative history, the agency has 
determined that the DSHEA does not apply to animal products.
    On October 25, 1994, the DSHEA (Pub. L. 103-417) was signed into 
law. The DSHEA amends the Federal Food, Drug, and Cosmetic Act (the 
act) to create a new regulatory scheme for ``dietary supplements.'' The 
DSHEA, among other things, amended the act by adding section 201(ff) 
(21 U.S.C. 321(ff)), which defines a ``dietary supplement,'' in part, 
as a product, other than tobacco, intended to supplement the diet that 
contains at least one or more of the following ingredients: A vitamin; 
a mineral; an herb or other botanical; an amino acid; a dietary 
substance for use to supplement the diet by increasing the total 
dietary intake; or a concentrate, metabolite, constituent, extract, or 
combination of any of the previously

[[Page 17707]]

mentioned ingredients (section 201(ff)(1) of the act). The DSHEA's main 
effect on the act was the removal of certain dietary supplement 
ingredients from regulation under 21 U.S.C. 321(s) and 348, two 
provisions of the act regulating the safety of food ingredients. In 
addition, the DSHEA permits certain limited claims to be made about 
dietary supplements without resulting in the supplement becoming a drug 
under 21 U.S.C. 321(g).
    The definition of ``dietary supplement'' in the DSHEA does not 
explicitly state whether it includes or excludes products intended for 
use in animals other than man. The legislative record, which is 
extremely brief, is likewise silent about this issue. FDA has carefully 
examined the new law to determine if it should be applied to animal 
products, and believes that it should not. When the DSHEA is read as a 
whole, FDA believes it is evident that Congress was concerned only with 
human products and did not consider animal products. For this reason, 
the agency concludes that Congress did not intend the law to apply to 
animal products. Equally important, there are some critical differences 
between products intended for human use and products intended for 
animal use that strongly favor maintaining the status quo for animal 
products. Accordingly, FDA does not intend to apply the DSHEA to animal 
products.
    There is much evidence in the DSHEA that Congress did not intend to 
apply the amendments to animal products. First, the extensive 
congressional findings in section 2 of the DSHEA focus strictly on the 
use of dietary supplements by humans. These findings begin by stating 
that ``improving the health status of United States citizens ranks at 
the top of the national priorities * * *,'' id., section 2(l) of the 
DSHEA (emphasis added); see also id., section 2(3)(A) and (2)(4) of the 
DSHEA (discussing the effect of supplements on human health conditions, 
such as ``cancer, heart disease, and osteoporosis'' and ``medical 
procedures, such as coronary bypass surgery or angioplasty.'') This 
strict focus on humans in the congressional findings reflects Congress' 
intent that the law apply only to humans. See United States v. Solid 
Gold Holistic Animal Equine Nutrition Center et al., No. CV 88-0473-GT, 
slip op. at 7-8 (S.D. Cal. March 2, 1995) (Ref. 1).
    Next, although the definition of ``dietary supplement'' contains no 
explicit reference to products intended for use by animals, part of the 
definition does contain an explicit reference to products intended for 
use by humans (section 3 of the DSHEA (creating 21 U.S.C. 
321(ff)(1)(E))). This is further evidence that Congress intended the 
law to apply to supplements used by humans, not supplements for other 
animals.
    Furthermore, many of the changes made by the DSHEA apply only to 
supplements intended for human use because the sections of the act that 
were amended by the DSHEA apply only to human products--yet another 
strong signal that Congress was only concerned with human supplements. 
For example, when the DSHEA sets out the standards for determining 
whether a product that has been approved or investigated as a drug can 
also be sold as a dietary supplement, it cites only to the human drug 
provisions of the act, but not to any of the animal drug provisions. 
See 21 U.S.C. 321(ff)(3). Likewise, the changes to food labeling made 
by the DSHEA apply only to human food because the sections in the act 
that are amended are in 21 U.S.C. 343(r), which applies only to ``food 
for human consumption.''
    Moreover, FDA believes the public health will be better protected 
if ingredients in animal dietary supplements are not subject to the 
special treatment provided for ingredients of human supplements by the 
DSHEA. Under the act's food additive provisions, 21 U.S.C. 321(s) and 
348, before FDA can approve a product for use in a food producing 
animal, FDA must determine that the product will not leave harmful 
residues in food (21 U.S.C. 348(b)(2) and (c)(5), and 21 CFR part 570). 
If the compound or any of its metabolites induces cancer, the act 
imposes additional requirements on the approval of the compound (21 
U.S.C. 348(c)(3)(A) and 21 CFR part 500, subpart E). However, nowhere 
in its revision of the regulation of ingredients in dietary supplements 
does the DSHEA address how the effect of supplements on food producing 
animals and human food safety is to be assessed. It seems unlikely that 
Congress would so alter the regulation of animal foods with no 
consideration--indeed, no mention--of the impact of the alteration on 
the safety of the nation's food supply.\1\
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    The findings make clear that one underpinning of the new 
legislation was Congressional concern that consumers should have the 
freedom to make their own choices about whether to take dietary 
supplements. However, that critical element of consumer choice is 
lacking when the supplement (or its metabolite) ends up in the diet 
as an unidentified residue in meat, milk, or eggs.
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    Not only are there human food safety concerns, but when compared 
with human use of supplements, there is less information on the safe 
use of dietary supplements in animals. Many substances that fall under 
the definition of dietary supplements for human consumption, such as 
herbs and other botanicals, have a history of use in humans that can be 
used to establish reasonably safe levels. However, the same is not true 
for use of many of these same ingredients in animals. As far as FDA is 
aware, very few substances that meet the criteria of 21 U.S.C. 
321(ff)(1) and (ff)(2) have any established history of safe use in any 
animal. Moreover, each animal species requires different nutrients, 
absorbs and metabolizes nutrients differently, and can exhibit 
different toxic reactions to food and its components. The lack of 
information on the safe use of these kinds of substances in animals, 
and the fact that the animal population is not as homogenous as the 
human population are two more reasons why FDA has determined that the 
DSHEA should not apply to animal products.\2\
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    \2\The law devotes no resources to the human and animal health 
issues raised by the use of supplements in animals. The DSHEA does 
mandate the establishment of an office within the National 
Institutes of Health to oversee scientific study of dietary 
supplements, as well as a seven-member commission to provide 
recommendations for the regulation of label claims for supplements. 
However, nothing in the law directs either new group to address the 
use of dietary supplements in animals. Thus, there will not be any 
independent resource from which the Center for Veterinary Medicine 
(CVM) can obtain unbiased information on benefits to animal health 
and production, safety to animals and humans consuming edible 
byproducts from treated animals, or the validity of claims for 
animal supplements. Lacking such a resource, FDA believes it is 
prudent for the burden to remain, as it is now, on the manufacturer 
to generate safety and effectiveness data and provide it to FDA for 
review in feed additive petitions and new animal drug applications.
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    Finally, many drugs intended to increase the production of meat, 
milk, egg, or fiber (so-called production drugs) or otherwise affect 
animal performance could arguably be covered as dietary supplements 
under the DSHEA. Currently, products bearing such production claims are 
animal drugs under the act, and as such, can only be marketed after 
approval by FDA after the manufacturer conducts extensive scientific 
studies to show that the drug is both safe (in animals and humans) and 
effective (21 U.S.C. 360b). To allow new production drugs to be 
marketed under the provisions of the DSHEA not only raises exactly the 
same food safety concerns previously discussed about food additives, 
but would also be unfair to existing approved products, and would serve 
as a disincentive to develop and use legitimate drugs in the future.
    In sum, although the DSHEA does not speak directly to the question, 
we think that the DSHEA was not intended to apply to animal products. 
Moreover, we

[[Page 17708]]

believe that there are significant, complex scientific and regulatory 
issues relating to human and animal safety that would need to be 
resolved by Congress before a similar scheme for animal supplements 
could be put into place. Accordingly, FDA has concluded that animal 
dietary supplements are not covered by the DSHEA.
    Interested persons may, on or before July 22, 1996, submit to the 
Dockets Management Branch (address above) written comments on this 
notice. Two copies of any comments are to be submitted, except that 
individuals may submit one copy. Comments are to be identified with the 
docket number found in brackets in the heading of this document. 
Received comments are available for public examination in the Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: April 11, 1996.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 96-9780 Filed 4-19-96; 8:45 am]
BILLING CODE 4160-01-F