REGULATORY FOCUS Proposed HRT Exemption

CPSC proposes a new rule to exempt HRT products from child-resistant packaging.

Erik Swain

Some hormone replacement therapy (HRT) products would be exempted from child-resistant/senior-friendly (CR/SF) packaging requirements if a new rule proposed by the Consumer Product Safety Commission (CPSC; Washington, DC) is adopted.

The proposal, published in the February 19, 2002, Federal Register [67 FR:7319–7321], would uniformly exempt all HRT products that rely only on the activity of one or more estrogen or progestogen substances. If implemented, the rule could mean that the costs of packaging products in this growing market segment will be reduced.

CPSC felt the need to act because HRT products are becoming increasingly popular, and drug companies are developing new ones constantly. They are administered to women to replace declining hormone levels after menopause, and the commission estimates that 40 million women in the United States will go through menopause in the next 20 years.

Under the Poison Prevention Packaging Act of 1970, all prescription drugs must be in CR/SF packaging unless otherwise exempted. CPSC is allowed to give exemptions for substances with low acute toxicity.

At the moment, CPSC exempts four sex-hormone-related products. These are oral contraceptives in mnemonic packages containing one or more estrogen or progestogen substances, conjugated estrogen tablets in mnemonic packages, norethindrone acetate tablets in mnemonic packaging, and medroxyprogesterone acetate tablets. Because available HRT products contain similar estrogen/progestin combinations to oral contraceptives, the commission has decided that it is "reasonable and consistent" to exempt them from CR/SF requirements also.

Some HRT products are encompassed by the four current exemptions. However, because of the way those current exemptions are written, others with equally low levels of toxicity are not encompassed by the exemption. Therefore, the proposal would make these others exempt also, provided the only active ingredients are estrogen or progestogen substances.

While human toxic dosages for estrogens and progestins have not been defined, there has been little evidence to show that they are toxic. Available medical literature suggests that acute toxicity is unlikely following overdosage and that the worst symptoms are likely to be gastrointestinal effects that require no special treatment.

Data from the Toxic Exposure Surveillance System of the American Association of Poison Control Centers (Washington, DC) also show that there is little to no toxicity associated with sex hormones. In acute exposures of estrogens, progestins, and oral contraceptives in children less than five years old from 1993 to 1998, there were no deaths, and almost all exposures were nontoxic. Of the 37,645 exposures, only one was classified as a "major outcome," but details on this case are not available, and it is possible that the child ingested a second substance or took an oral contraceptive formulation that contains iron, which can be toxic.

The commission is accepting comments until May 6, 2002. Comments should be mailed to the Office of the Secretary, Consumer Product Safety Commission, Room 502, 4330 East-West Highway, Bethesda, MD 20814-4408. They may also be sent by fax to 301/504-0127 or by e-mail to cpsc-os@cpsc.gov. All comments should be labeled, "Proposed HRT Exemption."

For further information, contact Jacqueline Ferrante, PhD, Division of Health Sciences, Directorate for Epidemology and Health Services, Consumer Product Safety Commission, Washington, DC 20207, 301/504-0477, ext. 1199.

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