Opinions Vary on Pre-DSHEA Supplement List

Responding to an FDA request for comment on whether the agency should develop a list of pre-1994 ingredients that would be presumed safe for use in dietary supplements under the Dietary Supplement Health and Education Act of 1994, the Center for Science in the Public Interest says it believes there are better uses for scarce agency resources. It says the critical question is whether FDA should expend scant resources to compile a list of ingredients when: (1) compliance with the statute is already required of any product marketed under current law as a pre-1994 ingredient, and reference documents and evidence of compliance should already be on file with industry; (2) there is no reason to think that development of such a list will promote public health, and yet it would impose an enormous burden on the agency to develop; (3) creation of the list risks even more widespread consumer misunderstanding regarding the government’s view of the safety of dietary supplements; and (4) there is concern that the process may be used to include ingredients that were not actually marketed prior to 1994.

The Consumer Healthcare Products Association says that as a prerequisite for developing a meaningful list of pre-DSHEA ingredients, FDA must recognize the inherent difficulties associated with establishing evidence for the marketing of a dietary ingredient more than 23 years ago and incorporate flexibility into any review process that is implemented. Similarly, it says, FDA should recognize that information concerning the manufacturing process used to produce a dietary ingredient should have no bearing on whether that ingredient was marketed prior to 10/15/1994. “We do not envision adoption of an authorized list of pre-DSHEA ingredients as an effort to avoid any aspect associated with the marketing of safe products,” the comment letter says. “We do agree with the agency that this process could have benefit for both industry and FDA.”

In its response, the United States Pharmacopeia offers suggestions for new ways that could be leveraged as a resource to FDA, industry, and the public in developing a pre-DSHEA list. It suggests (1) adopting a flexible, judicious, and defensible approach to the types of documentation that will provide sufficient confidence in the marketing status of a particular ingredient and (2) the potential utility of public standards in establishing both the identity of dietary ingredients marketed before 10/15/1994 and where such identity is conserved despite post-DSHEA manufacturing process changes.

Finally, the Pew Charitable Trusts says FDA should consider potential public health implications when developing the pre-1994 dietary supplement list. It says that the agency approach to building a list of old dietary ingredients should be conservative and the final list should include not only ingredient names but also details on sourcing and manufacturing to ensure that ingredients exempt from the new dietary ingredient definition are limited to those that are the same as those marketed prior to 1994 in all relevant ways. Pew also says FDA should consider issuing guidance or regulations making clear that ingredients on the list have not been proven to be safe, and that advertising or labeling that suggests list status as an indicator of safety would be false and misleading. Finally, it recommends that FDA focus its resources to maximize the agency’s ability to protect the public health with respect to dietary supplements.