[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.
---------------------------------------------------------------------------
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)
------------------------------------------------------------------------
5.29 oz..................... 10 180.
15.9 oz..................... 30 540.
2.2 lb...................... 66 1188.
25 packets.................. 25 450 (18 mg per packet).
------------------------------------------------------------------------
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
