[Federal Register Volume 60, Number 200 (Tuesday, October 17, 1995)]
[Rules and Regulations]
[Pages 53699-53701]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-25322]
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CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Part 1700
Poison Prevention Packaging Requirements; Exemption of Certain
Iron Containing Dietary Supplement Powders
AGENCY: Consumer Product Safety Commission.
ACTION: Final rule.
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SUMMARY: The Commission is amending its regulations to exempt from
child-resistant packaging requirements those dietary supplement powders
that have no more than the equivalent of 0.12 percent weight-to-weight
elemental iron. The Commission issues this exemption because there are
no known poisoning incidents with these products, and the dry powdered
form deters children from ingesting them in harmful amounts.
DATES: The exemption is effective on October 17, 1995.
FOR FURTHER INFORMATION CONTACT: Michael Bogumill, Division of
Regulatory Management, Consumer Product Safety Commission, Washington,
DC 20207; telephone (301) 504-0400 ext. 1368.
SUPPLEMENTARY INFORMATION:
A. Background
In 1978, the Consumer Product Safety Commission (``the
Commission'') required child-resistant packaging (``CRP'') for drugs
and dietary supplements that contain iron. 16 CFR 1700.14(a) (12) and
(13). The Commission issued these rules under the Poison Prevention
Packaging Act (``PPPA''), 15 U.S.C. 1471-1476, which authorizes the
Commission to require CRP to protect children under 5 years of age from
poisoning hazards posed by harmful household substances.
Specifically, CRP is required for dietary supplements ``that
contain an equivalent of 250 milligrams or more of elemental iron, from
any source, in a single package in concentrations of 0.025 percent or
more on a weight-to-volume basis for liquids and 0.05 percent or more
on a weight-to-weight basis for nonliquids.'' 16 CFR 1700.14(a)(13).
This requirement does not apply if iron is present only as a colorant.
Id.
On May 11, 1994, Nutritech, Inc. (``Nutritech''), petitioned the
Commission to exempt unflavored, unsweetened iron powders from CRP
requirements for dietary supplements containing iron. Nutritech
manufactures an unsweetened, unflavored vitamin, mineral, and amino
acid powder intended to be mixed with fruit juice. The petitioner
stated several reasons why CRP is unnecessary for this dietary
supplement. (1)\1\ The Commission published a notice in the Federal
Register on August 4, 1994, soliciting comments on the petition, 59 FR
39747, and received no responses.
\1\Numbers in parentheses identify documents listed at the end
of this notice.
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B. Proposed Rule and Comment
On April 7, 1995, the Commission published a notice granting
Nutritech's petition to initiate rulemaking and proposing to exempt
certain powdered iron-containing dietary supplements from CRP
requirements. 60 FR 17660. The Commission proposed that the exemption
would apply to dietary supplement powders, both flavored and
unflavored, with no more than the equivalent of 0.12 percent w/w
elemental iron.
In response to the proposed rule, the Commission received one
comment. The comment, submitted on behalf of an organization called SI
Metric, objected that the proposed regulation did not use proper SI
metric terminology. The Commission has considered the comment and has
made some changes in the preamble to ensure that measurements are
presented in metric terminology. However, the Commission declines to
make some changes suggested by the commenter--for example, using the
term mass rather than weight. The Commission also believes that its
expression of the percentage of concentration of iron for liquids and
non-liquids as weight-to-volume (``w/v'') or weight-to-weight (``w/w'')
measurements is appropriate. Based on the United States Pharmacopeia
guidelines, the percent w/v refers to the number of grams of a
constituent in 100 milliliters of solution, and the percent w/w is the
number of grams of a constituent in 100 grams of solution or mixture.
The Commission believes that its use of terminology is consistent with
use throughout the Federal government. Moreover, the terminology is
consistent with other regulations under the PPPA.
C. Toxicity Data
The minimum toxic and lethal doses of iron are not well defined.
Generally, doses of elemental iron from 20 to 60 milligrams per
kilogram of body weight (``mg/kg'') may produce mild symptoms of
poisoning, 60 mg/kg is the minimal dose for serious toxicity, and
approximately 180 to 250 mg/kg is considered a lethal dose. However,
fatalities of young children have been reported at lower doses. (2)(3)
According to the relevant scientific and medical literature, where
information on the formulation was available, the majority of pediatric
poisoning incidents involved solid iron--in the form of tablets or
capsules--with the remaining cases involving liquid preparations. Among
the reported ingestion incidents, fatalities and serious cases of
toxicity usually involve ingestion of adult preparations (such as
prenatal vitamins) that contain 60 mg or more of elemental iron per
tablet. The literature search did not identify a single case of
pediatric poisoning involving powdered iron formulations. (2)(3)(5)
When the Food and Drug Administration (``FDA'') published proposed
labeling and packaging requirements for iron-containing dietary
supplements and drugs, 59 FR 51030 (October 6, 1994), it decided to
limit the proposed rules to products in solid oral dosage forms
(capsules and tablets) and not include liquid or powder products. (2)
The Commission's own 1994 study of pediatric iron poisonings and
fatalities found that the majority of serious outcomes involved
products in solid or capsule forms. The report showed that all 36 of
the in-depth investigations of iron ingestion deaths of children under
5 years old occurring between 1986 and 1993 involved solid capsule or
tablet formulations. In 1993, 57 hospital emergency room cases
documented through NEISS involved ingestion of iron capsules or tablets
by children under 5 years old, and one involved liquid iron. As noted,
there were no known pediatric poisonings that involved powdered
formulations. This study was based on data from the Commission's
National Electronic Injury
[[Page 53700]]
Surveillance System (``NEISS''), in-depth investigations, the National
Center for Health Statistics (``NCHS'') and the American Association of
Poison Control Centers (``AAPCC''). (2)(5)
Due to the subcategories that AAPCC uses to classify iron ingestion
incidents, the data do not specifically address powdered iron-
containing formulations. However, for these AAPCC cases, powdered
formulations can be ruled out of all iron related fatalities involving
children under 5 years old, and 98.4 percent of cases with serious
symptoms, that were reported to the AAPCC between 1989 and 1992. (The
remaining 1.2% of cases did not specify the physical form of the
ingested product.) The formulations of the iron-containing products
involved in pediatric deaths is unavailable from NCHS death certificate
data. (2)
For powdered dietary supplements containing 18 mg of elemental iron
per tablespoon (0.12% weight-to-weight), a 10 kg child would have to
consume 11, 33, and 100 tablespoons to reach the respective minimal (20
mg/kg), serious (60 mg/kg), and lethal (180 mg/kg) toxicity levels.
This assumes none of the product is spilled during consumption. (2)(5)
D. Human Factors Data
Poisoning incidents involving ingestion of large amounts of any
powdered substance are relatively rare. Children are more likely to
ingest large quantities in the form of liquids or solids, such as
tablets and capsules. One reason for this distinction is the physical
difficulty children have handling and swallowing powders. Eating a dry
powder is difficult and time-consuming. Only small amounts can be eaten
at a time to allow the powder to absorb sufficient saliva so the powder
can be swallowed. Attempts to swallow too much at once or to swallow
too soon will likely result in aspirating the powder and stimulate
coughing, which would limit the amount ingested. Because of the time it
takes to ingest a powder, it is questionable that a young child could
eat a full tablespoon of powder at one time. The length of time
required to successfully ingest powders may increase the opportunity
for an adult to intervene. (2)(3)(5)
Children's motivation is also a factor in poisoning incidents.
Curiosity is the most common motivation among young children. Those
less than 3 years old explore through manipulative and oral activity.
The youngest at-risk children (less than 24 months) reportedly ingest
substances like dirt or powdered detergent by grasping a handful of the
substance and then opening their hands and using their palms to push
the substance into their mouths. This often results in spilling much of
the substance. (3)
Exploratory behavior among children 3 to 4 years old may be
somewhat more controlled than for younger children. For example, in a
study examining powdered aspirin, children 42 to 51 months of age had
difficulty picking up the fine aspirin powder, and when asked to taste
it, they did so by putting their fingers in the powder and licking
their fingers or by licking the powder directly on the table. This
behavior may tend to limit the amount ingested. (3)
In role-playing activities, children may use a powdered substance
in imitation of adult behavior. They may mix it with a liquid and drink
it or use the powder to substitute for some other food item (e.g., cake
mix). However, incomplete mixing of the product will result in a grainy
or lumpy mixture which may cause gagging. Repeated ingestion is
unlikely following such an experience. It is unlikely that a child
could effectively dissolve and ingest toxic amounts of powder with 0.12
percent weight-to-weight iron. (3)
Hunger is another potential motivation. The primary risk of
poisoning from these iron-containing supplements would be to a starved,
unattended child with no other available source of nutrition. However,
it is unlikely that a child would have the time and perseverance to
ingest a quantity of iron (11 tablespoons) that would be potentially
toxic (20 mg/kg). This is especially true since these products are
expensive, purchased by a select population of nutrition enthusiasts,
and are probably stored near other foods that would be more appealing
to children.(3)
The relative palatability of a substance may influence toxic
ingestions. Although flavor plays little or no role in determining
whether a product is ingested, it does influence the quantity ingested.
The unpleasant taste of the petitioner's product may deter ingestion of
toxic levels. Flavored products may pose a somewhat greater risk.
However, the other factors discussed above would likely limit the toxic
dose ingested of both flavored and unflavored powdered iron
supplements.(3)
E. Economic Data
According to the Food and Drug Administration, a dietary supplement
is ``a food, not in conventional form, that supplies a component to
supplement the diet by increasing the total dietary intake of that
component,'' Dietary Supplement Health and Education Act of 1994, P.L.
103-417. These are distinct from fortified foods, such as infant
formulas and meal replacements, which are intended to serve as the sole
item of a meal. The ingredients in dietary supplements and fortified
foods may be similar, but the marketing emphasis and health claims are
different.(4)
The petitioner markets two unsweetened, unflavored protein powder
supplements that are sold in individual serving packets or in
canisters. Each recommended serving of 1 tablespoon contains 18 mg of
iron and is mixed with juice for consumption. The following table shows
the available container sizes and the total iron content of each.
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Size Servings Total iron content (mg)
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150 g....................... 10 180
450 g....................... 30 540
1 kg........................ 66 1188
354 g....................... 25 450 (18 mg per packet)
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Sweetened or flavored supplements make up the major part of the
powdered dietary supplement market. Many are marketed as ``sports
nutritionals'' for fitness enthusiasts. These products are packaged in
cartons, canisters, packets, jugs, and pails in various sizes and
strengths of iron. Unit and dollar sales of powdered nutritional
products are not available. A spokesperson for the Council for
Responsible Nutrition (``CRN''), an industry group, estimates the
retail market for protein powders (including both supplements and
fortified foods) at $2 billion. CRN attributes the larger market share
(percent unknown) to flavored powders marketed as sports nutritionals
and diet supplements.(4)
F. Action on the Petition
As discussed above and in the notice of proposed rulemaking, the
relevant literature and data show no cases of child poisonings due to
iron-containing powders. In addition, it is unlikely that young
children would ingest toxic amounts of iron-containing supplement
powders which are difficult for children to handle without spilling or
to swallow without gagging. A child would have to ingest approximately
11 tablespoons of petitioner's product (20 mg/kg in a 10 kg child) in
order to produce a minimally toxic dose. Approximately 100 tablespoons
would be required for a lethal dose. Most of the factors that make
toxic ingestions of petitioner's unflavored product unlikely would also
apply to flavored supplement powders.
The Commission preliminarily concluded that the degree and nature
of the hazard to children presented by the
[[Page 53701]]
availability of dietary supplement powders with no more than the
equivalent of 0.12 percent weight-to-weight elemental iron are such
that special packaging is not required to protect children from serious
personal injury or serious illness resulting from handling, or
ingesting such substance. Accordingly, the Commission voted to grant
the petition and proposed to amend 16 CFR 1700.14(a)(13) to exempt from
requirements for child resistant packaging those dietary supplement
powders with no more than the equivalent of 0.12 percent weight-to-
weight elemental iron. 60 FR 17660 (April 7, 1995).
After considering all available and relevant information, the
Commission determines to issue the proposed exemption on a final basis.
G. Regulatory Flexibility Certification
Under the Regulatory Flexibility Act (Pub. L. 96-354, 5 U.S.C. 601
et seq.), when an agency issues proposed and final rules, it must
examine the rules' potential impact on small businesses. The Act
requires agencies to prepare and make available for public comment an
initial regulatory flexibility analysis if a proposed rule would have a
significant impact on a substantial number of small businesses, small
organizations, and small governmental jurisdictions.
When the Commission proposed to exempt powdered iron-containing
dietary supplements from CRP requirements, it found that the exemption
would not have any significant economic impact on a substantial number
of small entities. The exemption will give manufacturers of these
products the option of packaging products using any packaging they
choose. As far as CPSC is aware, powdered iron-containing dietary
supplements are not currently packaged in CRP. The Commission's
Compliance staff is exercising its enforcement discretion regarding
these products pending completion of this rulemaking. Thus, the
exemption will bring no change in the current packaging of products
subject to the exemption. The Commission is not aware of any
information that would alter its conclusion that this exemption will
not have any significant economic effect on a substantial number of
small entities.
H. Environmental Considerations
The Commission's regulations at 16 CFR 1021.5(c)(3) state that
rules exempting products from child-resistant packaging requirements
under the PPPA normally have little or no potential for affecting the
human environment. The Commission did not foresee any special or
unusual circumstances surrounding the proposed rule and found that
exempting these products from the PPPA requirements would have little
or no effect on the human environment. For this reason, when the
Commission issued the proposed exemption, it concluded that no
environmental assessment or impact statement is required in this
proceeding. That conclusion remains unchanged.
I. Effective Date
Because this rule provides for an exemption, no delay in the
effective date is required. 5 U.S.C. 553(d)(1). Accordingly, the rule
shall become effective upon publication of the final rule in the
Federal Register.
List of Subjects in 16 CFR Part 1700
Consumer protection, Infants and children, Packaging and
containers, Poison prevention, Toxic substances.
Conclusion
For the reasons given above, the Commission amends Title 16 of the
Code of Federal Regulations to read as follows:
PART 1700--[AMENDED]
1. The authority citation for part 1700 continues to read as
follows:
Authority: 15 U.S.C. 1471-1476. Secs. 1700.1 and 1700.14 also
issued under 15 U.S.C. 2079(a).
2. Section 1700.14(a)(13) is revised to read as follows:
Sec. 1700.14 Substances requiring special packaging.
(a) * * *
(13) Dietary supplements containing iron. Dietary supplements, as
defined in Sec. 1700.1(a)(3), that contain an equivalent of 250 mg or
more of elemental iron, from any source, in a single package in
concentrations of 0.025 percent or more on a weight-to-volume basis for
liquids and 0.05 percent or more on a weight-to-weight basis for
nonliquids (e.g., powders, granules, tablets, capsules, wafers, gels,
viscous products, such as pastes and ointments, etc.) shall be packaged
in accordance with the provisions of Sec. 1700.15 (a), (b), and (c),
except for the following:
(i) Preparations in which iron is present solely as a colorant; and
(ii) Powdered preparations with no more than the equivalent of 0.12
percent weight-to-weight elemental iron.
* * * * *
Dated: October 6, 1995.
Sadye E. Dunn,
Secretary, Consumer Product Safety Commission.
Reference Documents
The following documents contain information relevant to this
rulemaking proceeding and are available for inspection at the Office
of the Secretary, Consumer Product Safety Commission, Washington,
Room 502, 4330 East-West Highway, Bethesda, Maryland 20814.
1. Briefing Memorandum with attached briefing package, March 14,
1995.
2. Memorandum from Sandra E. Inkster, Ph.D., HSPS, to Jacqueline
N. Ferrante, Ph.D., HSPS, ``Review of Iron Toxicity: Relevance to a
Petition Requesting Exemption for Powdered, Iron-Containing Dietary
Supplements,'' February 15, 1995.
3. Memorandum from Catherine A. Sedney, EPHF, to Jacqueline N.
Ferrante, Ph.D., HSPS, ``Petition to Exempt Iron-Containing
Supplement Powders from PPPA Requirements,'' February 16, 1995.
4. Memorandum from Marcia P. Robins, EPSS, to Jacqueline N.
Ferrante, Ph.D., HSPS, ``Preliminary Market Information: Petition
for Exemption from Child-Resistant Packaging Requirements for
Powdered Iron-Containing Dietary Supplements,'' March 10, 1995.
5. Briefing Memorandum with attached briefing package, September
19, 1995.
6. Memorandum from Marcia P. Robins, EPSS, to Jacqueline N.
Ferrante, Ph.D., HSPS, Final Regulatory Flexibility Act Issues:
Petition for Exemption from Child-Resistant Packaging Requirements
for Powdered Iron-Containing Dietary Supplements,'' July 5, 1995.
[FR Doc. 95-25322 Filed 10-16-95; 8:45 am]
BILLING CODE 6355-01-P