FDA should determine what type of safety information is required on dietary supplement and functional food labeling and release a guidance on the issue, the General Accounting Office states in a July 11 report. The GAO document also identifies five other issues pertaining to dietary supplements and functional foods where FDA guidances are needed.

The report recommends FDA "develop and promulgate regulations or other guidance for industry on the safety-related information required on labels for dietary supplements and functional foods."

"The absence of such safety information poses a significant safety risk to some consumers," the report continues.

As an example, GAO notes that studies have shown St. John's wort decreases the efficacy of the protease inhibitor indinavir, but that FDA has not required companies marketing St. John's wort supplements to "warn consumers of this interaction on product labels."

The drug interaction was reported in the Feb. 12 issue of The Lancet; FDA and the National Institutes of Health issued a warning upon release of the study results (¹ Also see "St. John's Wort/HIV Protease Inhibitor Use Warnings Issued By FDA, NIH" - Pink Sheet, 14 February, 2000.).

Following the findings, the Consumer Healthcare Products Association filed a citizen petition with FDA June 20 requesting the agency require St. John's wort supplements carry a label statement warning about possible Rx interactions (² Also see "FDA Notices, Guidances Should Reflect St. John's Wort Interaction - CHPA" - Pink Sheet, 26 June, 2000.). The trade association has implemented a voluntary labeling program for its members.

GAO notes the FD&C Act requires that supplements and functional foods disclose "'facts that are material in the light of representations made about the product or with respect to consequences that may result from the use of the product.'" However, FDA has not clarified what information is "material," the report says.

The agency has not provided guidance on when, or if, "certain safety-related information should be included on labels, such as information on the maximum safe dosage of the ingredients in the product, possible interactions between the ingredients and drugs, or the need for certain groups, such as pregnant women, to avoid ingesting them," the report observes.

CHPA also has adopted a voluntary program encouraging its members to include a pregnancy/nursing warning on dietary supplement labeling; the group has filed a citizen petition with FDA on the issue as well. The agency held a public meeting March 30 to discuss safety issues related to supplement use during pregnancy (³ [A#05080140001]).

In correspondence with GAO during the report's drafting, FDA acknowledges it needs to provide further clarity on what safety information should be included on supplement and functional food labels and states it will add the activity to its 10-year strategic plan for dietary supplements next year.

However, the agency says the five other regulatory areas GAO cites as needing improvement are all mentioned in the Center for Food Safety & Applied Nutrition's plan, and will be addressed in turn.

GAO suggests FDA "establish firm time frames" to develop regulations or guidances in other areas, including: "the evidence needed to document the safety of new dietary ingredients in dietary supplements"; "the evidence needed to support structure/function claims"; and an enforcement strategy against firms selling products with unsubstantiated structure/function claims.

While the report states FDA has sent out 336 "courtesy letters" objecting to proposed claims, it adds the agency "has never asked a company...to voluntarily provide the agency with evidence supporting the claim, nor has FDA ever initiated an enforcement action to obtain access to the information through the courts."

Streamlining the enforcement process with regard to inappropriate dietary supplement claims is one of CFSAN's "A List" goals set out in its 2000 program priorities (⁴ Also see "Dietary Supplement Enforcement Procedure Streamlining Planned By CFSAN" - Pink Sheet, 14 February, 2000.).

The evidence supporting structure/function claims and consumers' ability to distinguish them from health claims also concerns GAO, which notes "some structure/function claims...are so vague or general that they have little or no scientific meaning and would be very difficult to prove."

Moreover, numerous comments to FDA have argued "the distinction between health and structure/function claims is artificial and that consumers view both types of claims as disease treatment or prevention claims," the report notes.

"Consequently, we believe that consumers may attempt to treat a disease with a product not capable of producing this benefit," GAO states. As a result, it recommends Congress establish an expert panel to determine whether the distinctions between the two types of claims are adequate.

The office's final two suggestions involve developing an advanced adverse event monitoring system for functional foods and dietary supplements and clarifying the boundary between the two types of products, "particularly the circumstances under which dietary supplements can be marketed in food form" (⁵ Also see "Dietary Supplement, Functional Food Regulatory Harmonization Urged By GAO" - Pink Sheet, 17 July, 2000.).

FDA has received 2,797 AERs potentially linked to dietary supplements since 1993, GAO says, including 105 deaths; ephedrine alkaloid products account for 1,173 of the reports. GAO adds that other sources show as many as 11.9 mil. people who have taken a botanical have said they experienced an adverse reaction.

In its response, FDA notes it has asked Congress for $2.5 mil. in its FY 2001 budget request to create a dietary supplement AE monitoring system.

Regarding the establishment of "firm time frames," FDA maintains its "limited resources can be better spent working toward accomplishing the targeted items than in fleshing out exactly how all the issues will be addressed" over the next 10 years.

The agency notes an anticipated cost for implementing the dietary supplement strategic plan should be known shortly, since the House Appropriations Committee has requested that FDA provide an estimate within six months after passage of the appropriations bill.

However, GAO contends a more detailed breakdown of when the agency plans to address these issues is preferable since it would enable interested parties to understand how FDA has prioritized them "in relation to other planned activities and aid in tracking FDA's progress toward implementing its plans."

"In addition...this information would be useful to the Congress in making decisions regarding future FDA appropriations," the report says.

Supplement Labeling Safety One Of Six Guidance Topics Raised By GAO

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