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This article was originally published in The Tan Sheet

Executive Summary

IRON SUPPLEMENT VOLUNTARY PROGRAMS UNVEILED BY CRN AND NNFA during a Sept. 28 meeting held by the Consumer Product Safety Commission in an effort to resolve the recent spate of pediatric iron poisonings. The two programs from the dietary supplement groups follow on the heels of the Nonprescription Drugs Manufacturers Association's September 27 announcement of its iron supplement voluntary member program ("The Tan Sheet" Sept. 27, p. 12). NDMA reported that it has received a 100% commitment among its members to comply with this measure. The National Nutritional Foods Association's program appears to adopt most of the NDMA proposals. It recommends to members that no product containing 30 mg per tablet should have a sweet outer coating; no child-resistant packaging exemption will be acceptable for products containing more than 30 mg of iron per tablet; and that one CRP exemption would be acceptable for products containing less than 30 mg of iron per tablet and above 250 mg per package. NNFA will also adopt the same warning used in NDMA's voluntary program: "Warning: Close tightly and keep out reach of children. Contains iron, which can be harmful or fatal to children in large doses. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately." The NNFA program, unlike NDMA'S, recommends that elemental iron should be limited to a maximum of 30 mg per unit dose and 30 mg per recommended dose. NNFA's Science and Technology Director Burton Kallman indicated that NDMA's program will affect a relatively small share of the iron supplement market since most of the initiatives are primarily directed at products containing more than 30 mg per unit of iron. Kallman noted that out of the 82 iron supplement products listed in NNFA's database, only three contain more than 30 mg of iron per tablet. NNFA also recently undertook an iron safety educational program directed at retailers and consumers. Kallman reported that a mailing went out to all NNFA members with an update describing the "problem with iron supplements" including some recent statistics of poisonings and fatalities among children. The mailing also included: information on child-resistant closures and the "fact that [CRPs] themselves do not appear to control this problem"; information that "describes the necessity of responsible adult action in keeping these products out the reach of children"; and a one-page flyer for copying and distribution that describes the potential danger of supplements and the importance of keeping them out of reach of children. The Council for Responsible Nutrition's program essentially adopts NDMA's warning label but does not include the CRP provisions. CRN maintained that "virtually all iron supplements are packaged in containers with child-resistant closures" and that most poisionings are due to parent failure in closing the caps securely. Peter Mayberry, from the blister-pack manufacturers association -- the Health Care Compliance Packaging Council -- suggested that the additional cost of unit-dose blister packs would be "money well-spent." Tobi Litovitz, American Association of Poison Control Centers, agreed that there would be fewer poisonings resulting in "major or life-threatening effects." Poison data presented at the meeting showed instances where children took as many as 100 iron tablets. Asked by Mayberry why the NDMA program did not include a recommendation for blister packs, Senior VP-Science & Technology William Soller, PhD, responded that the AAPCC database is "frustratingly poor in detail" and does not indicate that "we are dealing with CRP failures" in the case of iron poisonings. "Blister [packaging] assumes that other CRPs are not effective and we simply don't know that," he added. "Our focus in all of this is to close the packages tightly and mostly, to keep it out of the reach of children. That's probably one of the very core issues." A petition from state attorneys general in August had recommended use of blister packs. Last February, the Public Health Service issued a warning to parents to keep iron supplements out of the reach of children following a cluster of five iron-related deaths in Los Angeles County over a seven-month period. CPSC later issued a consumer product safety alert on iron supplements that urged the use of child-resistant packaging and that the products be kept away from children. CPSC also indicated that the commission is in the process of revising the performance standard used to define child-resistant packaging. In a presentation, Michael Gidding, from CPSC's office of compliance and enforcement, noted that the commission is considering changes in the adult portion of the two-part test. The first part of the protocol consists of two five-minute periods involving 200 children between the ages of 42 and 51 months evenly divided by age and sex. The children are given the child-resistant packaging to see if they can open it within five minutes. If the packaging is resistant to at least 85% of the participants, the children are given a demonstration of how to open the package and given an additional five minutes. Effectiveness specifications require that a minimum of 80% of the children cannot gain access to the package contents after this component of the test. Currently, the adult component of the protocol includes 100 adults between the ages of 18 and 45, 70% of whom are female, who are given the package with only the instructions that accompany it. The standard for adult effectiveness requires that a minimum of 90% of the adults are able to open the package within that time frame. CPSC said that it would like to revise the adult segment of the test to expand the age to 75 and the time limit to one minute. However, the commission indicated that industry is opposed to the change. CPSC indicated that several packaging manufacturers have developed child-resistant packaging that appears to surpass the proposed standard.

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