[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.

------------------------------------------------------------------------
            Size                Servings      Total iron content (mg)   
------------------------------------------------------------------------
150 g.......................          10   180                          
450 g.......................          30   540                          
1 kg........................          66   1188                         
354 g.......................          25   450 (18 mg per packet)       
------------------------------------------------------------------------

    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