FDA recently announced a new "Regulatory Strategy for the Further Implementation and Enforcement of the Dietary Supplement Health and Education Act of 1994" "Regulatory Strategy"). It also issued a Draft Guidance on Substantiation for Dietary Supplement Claims. These initiatives suggest that FDA plans to increase its scrutiny of dietary supplement products, particularly with respect to substantiation of claims and the submission and sufficiency of new dietary ingredient ("NDI") notifications.

Regulatory Strategy

The Regulatory Strategy (available at http://www.cfsan.fda.gov/~dms/ds3strat.html has three primary focus areas: safety, quality assurance, and labeling.

Safety

FDA believes that many products on the market contain NDIs for which 75-day premarket notifications were not submitted, or for which the notifications submitted were inadequate. [1] In order to ensure that these products do not pose a risk to consumers, FDA plans to:

• Improve the evidentiary base for its own safety and enforcement decision-making by collaborating with NIH and other government and private entities;

• Implement a more "transparent and systematic" process for evaluating safety concerns, which may include independent expert third party review/evaluation;

• Provide reliable scientific information about supplements to consumers via its website and other outreach efforts;

• Educate consumers and healthcare providers about how to report adverse events to FDA - and encourage them to do so; and

• Bring enforcement actions against marketed supplements that contain NDIs for which no premarket notification was submitted or for which the notification contained inadequate information.

FDA also held a public meeting on November 15, 2004 to obtain comment on new dietary ingredient issues, including: a) what information should be included in premarket notifications and b) under what circumstances chemical alteration or other processing of an old dietary ingredient should make it a "new" dietary ingredient for which premarket notification is required. The agency specifically noted an April 2004 Institute of Medicine report which recommended that whenever the formulation or processing of a dietary ingredient is changed, it should be considered a "new dietary ingredient" for which a premarket notification is required. Discussion at this meeting strongly suggests that FDA is considering a more restrictive view of "old" dietary ingredients and other matters.

Quality

FDA is committed to finalizing the dietary supplement current good manufacturing practice (CGMP) early in 2005. Acting Commissioner Crawford has suggested that the final rule will reflect industry input, but not veer away from the proposed rule enough to warrant a re-proposal.

Labeling

FDA is concerned about the prevalence of what it believes are unsubstantiated structure/function claims for supplement products. In order to protect consumers' health and pocketbooks, FDA plans to continue to identify and take appropriate action against products making unsupported claims, and to more closely scrutinize products in the marketplace (focusing initially on weight loss products) by:

• Doing surveillance on supplement facts panels to determine whether dietary ingredients can lawfully be marketed;
  
• Obtaining and analyzing samples of marketed supplements to determine whether their contents are consistent with their labeling; and
• Identifying and taking enforcement action against supplements whose labeling does not reveal material facts (such as drug interaction information), focusing on products that pose the greatest risk.

Draft Guidance

The Draft Guidance on the substantiation of claims for dietary supplements (available at: http://www.cfsan.fda.gov/~dms/dsclmgui.html) is intended to provide a clear and consistent description of FDA's expectations regarding the nature, quantity, and quality of evidence it considers sufficient. The Draft Guidance does not set forth a specific formula for claims substantiation, but does adopt the FTC's "competent and reliable scientific evidence" standard, and recommends that companies consider the following issues (among others):

• The meaning of the claim, including the overall message of the claims as a whole;
• The relationship of the evidence to the claim, including whether the studies specify and measure the dietary supplement at issue and whether a similar population was used;
• The quality of the evidence, including the study design, population, method of analysis, and whether the study was peer-reviewed;
• The totality of the evidence, including the strength of the "entire body of evidence" -- not just favorable studies.

[1] Under Section 413(c) of the FDCA, an "NDI" is a dietary ingredient that was not marketed in the United States before October 15, 1994. A dietary supplement that contains an NDI is deemed to be adulterated unless one of two conditions is met; either: (1) the dietary supplement contains only dietary ingredients that have been present in the food supply as an article used for food in a form in which the food has not been chemically altered; or (2) there is a history of use or other evidence of safety establishing that the dietary ingredient when used under the conditions recommended or suggested in the labeling of the dietary supplement will reasonably be expected to be safe, and the manufacturer or distributor of the dietary supplement containing the NDI provides FDA with information, including any citation to published articles, which is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such dietary ingredient is reasonably be expected to be safe. This notification is to be provided at least 75 days before the product is introduced or delivered for introduction into
interstate commerce.