The Food and Drug Administration (FDA) is announcing two decisions on health claims that were the subject of a court decision. One proposed claim that stated 0.8 mg of folic acid in a dietary supplement was more effective in reducing the risk of neural tube defects than a lower amount in foods was not authorized. Although FDA determined that this claim could not be appropriately qualified without being misleading, the agency did provide examples of appropriate qualified claims.
FDA determined that the second proposed health claim about dietary fiber and reduced risk of colorectal cancer could not be authorized because the results of studies about dietary fiber consistently showed a lack of relationship between dietary fiber supplements and the risk of colorectal cancer. Neither could the claim be qualified because the suitable evidence against the claim outweighed the evidence for it.
Further, FDA announced that decisions on two other health claims that were also the subject of the court case, one about omega-3 fatty acids and the other about antioxidants, would be issued no later than October 24, 2000.
FDA has modified its approach in processing these claims and future new health claim petitions for dietary supplements. If a health claim meets the significant scientific agreement (SSA) standard of evidence, the agency will publish a proposal or an interim final rule to authorize the claim. Rather than denying all petitions that do not meet the SSA standard, FDA intends to exercise enforcement discretion for qualified health claims for dietary supplements when the following conditions are met:
- The health claim petition meets FDA requirements for such petitions;
- The scientific evidence supporting the claim outweighs the scientific evidence against the claim;
- Consumer health and safety are not threatened; and
- The claims meet the general requirements for a health claim.
In 1990, FDA adopted the same procedure for health claims for dietary supplements that Congress had prescribed in the Nutrition Labeling and Education Act for conventional foods. This procedure requires that the evidence supporting a health claim be presented to FDA for review before the claim can appear on the labeling.
On January 6, 1993, FDA announced its decision not to authorize the use of three health claims for conventional foods: dietary fiber and cancer, antioxidant vitamins and cancer, and omega-3 fatty acids and coronary heart disease. The agency followed up with a decision not to authorize the claims in the labeling of dietary supplements on October 14, 1993. On that same day, FDA proposed to authorize a health claim for the relationship between folate and reduced risk of neural tube defects, and proposed not to allow such a claim to include a statement that folate from one source is more effective than folate from another source. This proposal became final for dietary supplements in January 1994, and FDA subsequently issued a final rule authorizing use of the claim on dietary supplements and conventional foods on March 5, 1996.
In 1998, FDA's general health claim regulations for dietary supplements were challenged, as was FDA's decision not to authorize the four health claims. On January 15, 1999, the U.S. Court of Appeals for the D.C. Circuit invalidated the regulations prohibiting use of the four health claims and directed FDA to reconsider authorization of the claims. The court also required FDA to clarify the SSA standard for authorizing health claims, either by issuing a regulatory definition of SSA or by defining it on a case-by-case basis. On March 1, 1999, FDA filed a petition for a rehearing by the full Court of Appeals, which was denied.
In December 1999, the Federal Register published FDA's plans to carry out the court's decision. Since the court's decision, FDA has:
- Updated scientific evidence on the four claims (Fall 1999-Spring 2000);
- Issued guidance clarifying the SSA standard (December 22, 1999);
- Held a public meeting to solicit input on changes to health claims regulations on dietary supplements (April 4, 2000);
- Issued a rule to revoke the regulations invalidated by the court decision (0ctober 3, 2000);
- Issued a notice updating its implementation strategy (October 6, 2000); and
- Announced a decision on two of the four health claims (October 10, 2000).
Details on these decisions may be found on the FDA Website at www.cfsan.fda.gov and selecting the section "Dietary Supplements" under "Program Areas" or by choosing one of the documents below: