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

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

ion'') 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

sed 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)

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

lations 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

ng 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)

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.

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

tional

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 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

l 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

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.

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

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