Health Claims for Dietary Supplements: FDA Rejects, Qualifies and Remains Undecided
WASHINGTON--Almost eight years later, Pearson v. Shalala is still making headlines. In a follow-up to its interim enforcement strategy for Pearson v. Shalala, the Food and Drug Administration (FDA), in reviewing the four health claims intended for dietary supplements, did not authorize two. The agency modified the language of one and postponed its decision on the remaining one.
So far, the FDA's decisions have been met with incredulity. "It's a mixed bag," said Jonathan Emord, of Emord & Associates P.C., the law firm that represented the plaintiffs (including scientists, dietary supplement companies and more than 700 physicians) in Pearson v. Shalala.
FDA determined that the claims for fiber and folic acid could not be "appropriately qualified." However, the agency did consider whether the claims could be reworded with more appropriate, qualifying language. According to an FDA "Talk Paper," it could not authorize the claim that dietary fiber may reduce the risk of colon cancer, because studies about dietary fiber "consistently showed a lack of relationship between dietary fiber supplements and the risk of colorectal cancer." FDA also found that there was more evidence against the claim than for it, one of the agency's prerequisites for issuing a health claim.
According to Emord, the FDA decision for fiber is unsupportable, but the agency's decision may also be based on different endpoints (conditions noted at the end of the study) than what the plaintiffs had envisioned. Rather than fight the decision now, he said that other studies are being conducted using alternative endpoints to determine if the claim is justified.
The National Nutritional Foods Association (NNFA) released a statement suggesting that FDA should be flexible in reviewing health claims for dietary supplements, but the agency should also make certain that adequate scientific standards continue to be upheld. "My impression is that FDA relied on a thorough review of the science for their determination," said Phil Harvey, Ph.D., NNFA's director of science and quality assurance. "Although the outcome is not what some would have liked, the process was fair."
FDA also did not authorize that 0.8 mg of folic acid in supplement form may be more effective than that found in food in reducing the risk for neural tube defects in pregnant women. FDA explained its decision by stating that the submitted claim could not be appropriately qualified without being misleading. However, FDA did provide examples of appropriately qualified claims.
"They are giving women the misleading impression that folic acids found in food are equally reliable in reducing the risk of neural tube defect births than dietary supplements with 0.8 mg [of folic acid] in them," Emord said, adding that FDA is erroneously guiding women into believing that daily values of folic acid can be consumed with the variable amounts found in meats and vegetables. Also, he notes, storage and heating foods destroy folate levels. He said he plans to sue in order to get this health claim ultimately approved.
However, FDA decided that, even though the claim was suggestive and inconclusive, the scientific evidence for the cardioprotective benefits of omega-3 fatty acids outweighed those against it. FDA approved the following claim: "The scientific evidence about whether omega-3 fatty acids may reduce the risk of coronary heart disease (CHD) is suggestive, but not conclusive. Studies in the general population have looked at diets containing fish and it is not known whether diets or omega-3 fatty acids in fish may have a possible effect on a reduced risk of CHD. It is not known what effect omega-3 fatty acids in fish may or may not have on risk of CHD in the general population." This will replace the industry-suggested claim of "Consumption of omega-3 fatty acids may reduce the risk of coronary heart disease," which FDA considered suggestive, inconclusive and misleading.
"An overwhelming amount of evidence from various studies certainly demonstrates that omega-3 fatty acids [by themselves] have cardiovascular benefits," said Bob Walker, vice president of sales and marketing at Pharmline, a manufacturer of omega-3. He also said that there are ways to get around this modified claim. "I think there needs to be more PR and better consumer education [on the industry's part]."
FDA explained in its Oct. 31 letter to Emord & Associates that research was conducted looking at people who consumed fish, and it is unknown whether the fish or the omega-3 in the fish led to the resulting reduction in heart disease. By rejecting the industry-suggested health claim, FDA contradicts the American Heart Association's advice to eat at least two servings of fish per week for its omega-3's cardioprotective effects.
Emord said he and his clients were pleased to see FDA permit an association with omega-3 fatty acids and the reduction of heart disease. However, he said he was disappointed that the agency will not allow this claim to be used on the food omega-3 is derived from (fish). Also, the claim itself is "so wordy and so incomprehensible in the second and third sentences, that we think that most consumers will simply not understand what the agency is trying to convey," Emord stated. As a result, he said that companies in the omega-3 business plan to inundate the market with a consumer-savvy revised version of the FDA claim, not only on dietary supplements but on food products as well. Emord cites the First Amendment for the companies' decision.
FDA also stipulated that labels must guide customers to consume less than two grams, (preferably only one gram) per day so as to not exceed the upper intake level of three grams per day; the agency explained in its letter that this is a safety precaution, as every individual has different omega-3 baseline levels.
FDA postponed its decision on antioxidants' effects on cancer, citing new studies, the amount of antioxidants and the various cancers were making its decision more labor-intensive. FDA expects to release its decision on Nov. 30.
For additional information about the decisions made on fiber and folic acid, visit www.cfsan.fda.gov/~lrd/tppearso.html. For a copy of FDA's health claim for omega-3 fatty acids, visit www.cfsan.fda.gov/~dms/ds-ltr11.html.