The FDA's rules provide a mechanism by which dietary supplement marketers can petition the FDA to issue a rule that specific health claims can be made about dietary supplements. 21 CFR §101.70 lays out the procedural steps that a petitioner must follow to submit a proposed health claim. In addition to following these procedural rules, 21 CFR §101.14 sets forth the standard pursuant to which the FDA will evaluate the claim.

Until October 10th, 2000, the standard that dietary supplement marketers were required to meet in order to make a health claim for supplements was the same standard that the FDA applied to foods. That standard provides:

FDA will promulgate regulations authorizing a health claim only when it determines, based on the totality of publicly available scientific evidence (including evidence from well-designed studies conducted in a manner which is consistent with generally recognized scientific procedures and principles), that there is significant scientific agreement, among experts qualified by scientific training and experience to evaluate such claims, that the claim is supported by such evidence.1

While this sounds good in theory, the FDA was extremely stingy when it came to authorizing specific health claims for both foods and dietary supplements. However, in 1993, four proposed health claims were submitted to the FDA by Durk Pearson, Sandy Shaw, The American Preventative Medical Association, and Citizens for Health. The claims the petitioners sought were:

(1) "Consumption of antioxidant vitamins may reduce the risk of certain kinds of cancers."

(2) "Consumption of fiber may reduce the risk of colorectal cancer."

(3) "Consumption of omega-3 fatty acids may reduce the risk of coronary heart disease."

(4) ".8 mg of folic acid in a dietary supplement is more effective in reducing the risk of neural tube defects than a lower amount in foods in common form."

The FDA rejected these claims because the evidence supplied by the petitioners did not, in the FDA's view, satisfy the "significant scientific agreement" standard of §101.14. The petitioners appealed the FDA's decision to the U.S. District Court, but the FDA's decision was upheld.2 The petitioners then appealed the decision to the United States Court of Appeals and finally met with success.3

Pearson v. Shalala

The Court of Appeals reversed the District Court's decision, and held that the FDA's "significant scientific agreement" standard was unconstitutionally vague and unduly restricted the petitioner's First Amendment right to free speech. The court further found that there were less restrictive regulatory options available to the FDA, such as the use of disclaimers in conjunction with the claims, which would nevertheless satisfy the FDA's regulatory concerns. In the end, however, the court ordered the FDA to more clearly articulate what the term "significant scientific agreement" means.

On October 6th, the FDA issued its long awaited clarification to the "significant scientific agreement" standard. While the significant scientific standard shall remain the standard that the agency will apply when deciding whether to issue a rule authorizing a health claim, the FDA also stated that it will "exercise its enforcement discretion in appropriate circumstances."4 Anyone who considers this statement will be left shaking his or her head, wondering what that means! To clarify, the FDA stated:

Specifically, the agency will consider exercising enforcement discretion for a dietary supplement health claim when the following conditions are met: (1) The claim is the subject of a health claim petition that meets the requirements of §101.70; (2) the scientific evidence in support of the claim outweighs the scientific evidence against the claim, the claim is appropriately qualified, and all statements in the claim are consistent with the weight of the scientific evidence; (3) consumer health and safety are not threatened; and (4) the claim meets the general requirements for health claims in §101.14, except for the requirement that the evidence supporting the claim meet the significant scientific agreement standard and the requirement that the claim is made in accordance with an authorizing regulation.5

So there we have it! Shaking off that which is not new, the import of the new standard is that the scientific evidence supporting the claim must outweigh the scientific evidence against the claim. If the scientific evidence satisfies this standard, and the other requirements are met, the FDA will issue a letter to the petitioner indicating that it is appropriate to make a qualified health claim.6

The Status of the Pearson Claims

So how has the FDA applied its new standard? Four days after the new standard was issued, the FDA announced decisions on two of the four Pearson health claims. With respect to the claim that consumption of fiber may reduce the risk of colorectal cancer, the FDA analyzed the evidence both for and against the claim and found that the scientific evidence for the claim did not outweigh the contrary evidence. Accordingly, the FDA rejected the claim.

The FDA also issued its decision on the claim regarding Folic Acid and Neural Tube Defects ("NTDs"). As with the fiber claim, the NTD claim was also rejected. However, the basis for the FDA's finding that the claim was improper was not based on the fact that there was insufficient evidence to link consumption of Folic Acid to a decrease in NTDs. Rather, it was based on the finding that the specific claim stated that ".8 mg" of Folic Acid helped prevent NTDs. The FDA stated that the evidence it reviewed indicated that lesser amounts of Folic Acid were linked to NTD prevention.

To accommodate this finding, the Agency stated that it will exercise its enforcement discretion, and will allow Folic Acid/NTD claims that are properly qualified. The FDA specifically cited the following four claims as examples of that which it will permit:7

Example 1: Healthful diets with adequate folate may reduce a woman's risk of having a child with a brain or spinal cord birth defect. The Institute of Medicine of the National Academy of Sciences recommends that women capable of becoming pregnant consume 400 mcg folate daily from supplements, fortified foods, or both, in addition to consuming food folate from a varied diet.

Example 2: Healthful diets with adequate folate may reduce a woman's risk of having a child with a brain or spinal cord birth defect. The scientific evidence that 400 mcg folic acid daily reduces the risk of such defects is stronger than the evidence for the effectiveness of lower amounts. This is because most such tests have not looked at amounts less than 400 mcg folic acid daily.

Example 3: Healthful diets with adequate folate may reduce a woman's risk of having a child with a brain or spinal cord birth defect. Women capable of becoming pregnant should take 400 mcg folate/day from fortified foods and/or a supplement, in addition to food folate from a varied diet. It is not known whether the same level of protection can be achieved by using only food that is naturally rich in folate. Neither is it known whether lower intakes would be protective or whether there is a threshold below which no protection occurs.

Example 4: Healthful diets with adequate folate may reduce a woman's risk of having a child with a brain or spinal cord birth defect. Women capable of becoming pregnant should take 400 mcg of folate per day from a supplement or fortified foods and consume food folate from a varied diet. It is not know whether the same level of protection can be achieved by using lower amounts.

Granted, no supplement marketing genius is going to do back flips over these claims given the extensive qualifications that are attached. Nevertheless, these claims are but the first examples we have seen applying the new health claim standard. It will be most interesting to see where the FDA goes with the antioxidant/cancer claim and the omega-3 fatty acid/coronary heart disease claim.

The FDA has indicated that it intends to have its decisions on these claims by October 24th, so watch your e-mail on the 25th, as we will promptly send out a supplemental SalesWatch Online to update you on these critical claims. In addition, we are certain to see an influx of new health claims submitted to the FDA for approval in the coming months. While I certainly do not anticipate that the FDA will open the floodgates and allow a multitude of health claims, the door has been opened a bit wider for marketers that have done their homework and have strong scientific support for their products to make more compelling marketing claims beyond benign structure/function claims.

1. 21 CFR §101.14.

3. Pearson v. Shalala, 164 F.3d 650 (DC Cir. 1999).

4. 65 Fed. Reg. 59856

5. Id.

6. Letter Regarding Dietary Supplement Health Claim for Fiber With Respect to Colorectal Cancer, Docket No. 91N-0098.

7. Letter Regarding Dietary Supplement Health Claim for Folic Acid With Respect to Neural Tube Defects, Docket No. 91N-100H.