WASHINGTON, D.C. (November 11, 2004) – After a thorough examination of the major initiatives designed to fully implement the Dietary Supplement Health and Education Act (DSHEA) offered last week by the Food and Drug Administration (FDA), the National Nutritional Foods Association today issued general support while voicing concern about certain elements of the agency’s plan.
“In order to work, laws need to be fully implemented and enforced,” said David Seckman, NNFA’s executive director and CEO. “To that extent, we are supportive of the FDA’s recent initiatives regarding DSHEA. However, there are some aspects of the agency’s plan that are cause for concern and require both formal comment from industry and clarification from the FDA.”
According to Seckman, the three areas of greatest concern include the “signal detection” approach to safety issues, heightened review and increased enforcement of new dietary ingredient safety submissions, and the focus on cautionary information required on dietary supplement labels.
Following, section by section, is NNFA’s top line analysis of selected key areas of FDA’s recently released initiatives.
According to FDA, the agency intends to react promptly to “signals” of potential safety issues coming from federal, state or local counterparts; adverse event reports; foreign regulatory actions; media reports; consumer groups; and/or experts.
NNFA believes FDA should carefully consider all relevant data on safety before taking action against a supplement. As an element of its “signal detection,” the agency should be aware that adverse event reports (AERs) are notoriously unreliable and must come through a system that has been redesigned to screen out inappropriate reports. In addition, NNFA cautions FDA that foreign actions on dietary supplements have often been based on very different government and consumer expectations that are not relevant to the United States.
New Dietary Ingredients
FDA has stated that it intends to bring enforcement actions against dietary supplements currently on the market that were not “grandfathered” under DSHEA and for which no “new dietary ingredient” (NDI) safety information has been submitted. To date, FDA has taken such action only once – against products containing androstenedione – and this came after years of controversy. It is not clear how aggressively the agency will pursue this new course of action.
NNFA hopes that FDA will issue additional guidance on NDI procedures before taking action against products that it believes should have been the subject of pre-market submissions. In fact, in 2002, NNFA sent comments to FDA urging the agency to clarify NDI requirements and the type of data needed when a submission is deemed necessary. NNFA will further comment on NDIs at an upcoming public meeting to be held by the FDA on November 15, 2004.
FDA Actions on Labeling
In an effort to clarify its approach to ensure dietary supplements labels are truthful and not misleading and that claims are substantiated, the FDA has drafted a guidance for industry on dietary supplement claims. In large part this document echoes the Federal Trade Commission’s (FTC) substantiation policy, requiring there to be “competent and reliable scientific evidence” for claims. FDA makes clear, however, that for studies to be deemed relevant, they must bear a relationship to the specific claim being made.
While NNFA has always supported the position that claims used on dietary supplement labels be substantiated by scientific evidence, the association can offer only qualified support of the FDA’s initiative as outlined in the draft guidance because it is simply too narrow.
As an example, FDA takes the position that the endpoints of studies used to substantiate structure/function claims must match the claim being made. For instance, studies supporting an “increased circulation to the brain” claim should have looked solely at increased circulation in the brain – and not at a broader disease state.
This position could potentially limit the body of evidence that dietary supplement companies can draw from in substantiating product claims. Many studies are funded and undertaken to research the effects of a substance on disease, rather than on a structure or function of the body alone. Responsible scientists are able to draw information from such studies that support lesser claims. Therefore, FDA should not categorically exclude such studies from forming the basis for structure/function claims.
An additional concern of NNFA’s is about the restrictions the draft guidance places on the use of foreign studies in substantiating claims. In the guidance, FDA states that foreign studies may be used to substantiate claims as long as there are no significant differences between the study population and the U.S. population. FDA notes that confounding differences that would undermine the use of such studies include “differences in diets, general health, or patterns of use.” While NNFA understands FDA’s point, the association is concerned that this reasoning could be used to undermine any foreign-based studies used for claim substantiation. Instead, foreign studies should be able to form the basis of substantiation if experts in the field could rely on them for such support.
FDA’s new focus on disclosure of “material facts” on the label is of particular concern as DSHEA does not require dietary supplement labels to contain any warning information. FDA’s move here, however, appears to implicitly require such warnings by placing the burden on manufacturers and distributors to have and then disclose such information. NNFA is unclear as to how FDA expects companies to generate this information, and what level of disclosure will meet the agency’s new “requirement.”
Through both formal comments to FDA and in-person testimony, NNFA will communicate its concerns, seek clarification where needed and inform its members and others of the outcome.
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The National Nutritional Foods Association (www.nnfa.org) is the nation’s largest and oldest non-profit organization dedicated to the natural products industry. NNFA represents more than 8,000 retailers, manufacturers, wholesalers and distributors of natural products, including foods, dietary supplements, and health/beauty aids. NNFA has national offices in Washington, D.C. and Newport Beach, Calif., as well as seven regional offices throughout the United States.
Tracy Taylor, Vice President of Public Affairs and Communications
(202) 223 – 0101