[Federal Register Volume 60, Number 67 (Friday, April 7, 1995)]
[Proposed Rules]
[Pages 17660-17662]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-8522]



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CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Part 1700


Poison Prevention Packaging Requirements; Proposed Exemption of 
Certain Iron-Containing Dietary Supplement Powders

AGENCY: Consumer Product Safety Commission.

ACTION: Proposed rule.

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SUMMARY: The Commission proposes to amend 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 proposes 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: Comments on the proposed rule must be received by the Commission 
no later than June 21, 1995.

ADDRESSES: Comments should be mailed, preferably in five (5) copies, to 
the Office of the Secretary, Consumer Product Safety Commission, 
Washington, D.C. 20207, or delivered to the Office of the Secretary, 
Consumer Product Safety Commission, Room 502, 4330 East-West Highway, 
Bethesda, Maryland 20814; telephone (301) 504-0470.

FOR FURTHER INFORMATION CONTACT: Jacqueline Ferrante, Ph.D., Project 
Manager, Directorate for Health Sciences, Consumer Product Safety 
Commission, Washington, D.C. 20207; telephone (301) 504-0477.

SUPPLEMENTARY INFORMATION:

A. Background

    Although iron is essential for good health, in large doses it can 
be toxic. For this reason, 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., 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 that CRP 
is unnecessary for this dietary supplement because: (i) The substance 
alone is unpalatable; (ii) due to the powder consistency of this 
substance, a child would not consume a toxic amount without gagging; 
and (iii) to Nutritech's knowledge, there have been no poisoning 
incidents involving this product in its 22 year history.(1)1 The 
Commission published a notice in the Federal Register soliciting 
comments on the petition, 59 FR 39747, and has received no responses.

    \1\Numbers in parentheses identify documents listed at the end 
of this notice.
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B. 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)
    Recently, 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). Based on 
its review of iron poisonings involving children under 6 years of age, 
the FDA decided to limit its 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 Surveillance System (``NEISS''), in-depth 
investigations, the National Center for Health Statistics (``NCHS'') 
and the American Association of Poison Control Centers (``AAPCC'').(2) 
[[Page 17661]] 
    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 
(20mg/kg), serious (60mg/kg), and lethal (180 mg/kg) toxicity levels. 
This assumes none of the product is spilled during consumption.(2)

C. Human Factors Data

    Poisoning incidents involving ingestion of large amounts of any 
powdered substance are relatively rare. Rather, 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)
    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)

D. 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, 
Public Law 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.

------------------------------------------------------------------------
            Size              Servings       Total iron content (mg)    
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5.29 oz.....................        10  180.                            
15.9 oz.....................        30  540.                            
2.2 lb......................        66  1188.                           
25 packets..................        25  450 (18 mg per packet).         
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    Sweetened or flavored supplements make up the major part of the 
powder 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)

D. Action on the Petition

    As discussed above, 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 [[Page 17662]] 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.
    After considering the available information, the Commission 
preliminarily concludes that the degree and nature of the hazard to 
children presented by the 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 proposes 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.

E. Regulatory Flexibility Certification

    Under the Regulatory Flexibility Act (Public Law 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.
    The exemption proposed below, to exempt powdered iron-containing 
dietary supplements from CRP requirements, 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 
proposed exemption will bring no change in the current packaging of 
products subject to the exemption. Accordingly, the Commission 
concludes that this exemption will not have any significant economic 
effect on a substantial number of small entities.

F. 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 does not foresee any special or 
unusual circumstances surrounding this proposed rule. Therefore, 
exempting these products from the PPPA requirements will have little or 
no effect on the human environment. For this reason, the Commission 
concludes that no environmental assessment or impact statement is 
required in this proceeding.
G. Effective Date

    Since the proposed 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: Pub. L. 91-601, secs. 1-9, 84 Stat. 1670, 15 U.S.C. 
1471-76, Secs. 1700.1 and 1700.14 also issued under Pub. L. 92-573, 
sec. 30(a), 88 Stat. 1231, 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: April 3, 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.

[FR Doc. 95-8522 Filed 4-6-95; 8:45 am]
BILLING CODE 6355-01-P