Health Claims for Dietary Supplements: FDA Rejects, Qualifies and Remains Undecided

Health Claims for Dietary Supplements: FDA Rejects,Qualifies and Remains Undecided

WASHINGTON--Almost eight years later, Pearson v. Shalala is stillmaking headlines. In a follow-up to its interim enforcement strategy for Pearsonv. Shalala, the Food and Drug Administration (FDA), in reviewing the fourhealth claims intended for dietary supplements, did not authorize two. Theagency modified the language of one and postponed its decision on the remainingone.

So far, the FDA's decisions have been met with incredulity. "It's amixed bag," said Jonathan Emord, of Emord & Associates P.C., the lawfirm that represented the plaintiffs (including scientists, dietary supplementcompanies 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 whetherthe claims could be reworded with more appropriate, qualifying language.According to an FDA "Talk Paper," it could not authorize the claimthat dietary fiber may reduce the risk of colon cancer, because studies aboutdietary fiber "consistently showed a lack of relationship between dietaryfiber supplements and the risk of colorectal cancer." FDA also found thatthere was more evidence against the claim than for it, one of the agency'sprerequisites for issuing a health claim.

According to Emord, the FDA decision for fiber is unsupportable, but theagency's decision may also be based on different endpoints (conditions noted atthe end of the study) than what the plaintiffs had envisioned. Rather than fightthe decision now, he said that other studies are being conducted usingalternative endpoints to determine if the claim is justified.

The National Nutritional Foods Association (NNFA) released a statementsuggesting that FDA should be flexible in reviewing health claims for dietarysupplements, but the agency should also make certain that adequate scientificstandards continue to be upheld. "My impression is that FDA relied on athorough review of the science for their determination," said Phil Harvey,Ph.D., NNFA's director of science and quality assurance. "Although theoutcome 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 maybe more effective than that found in food in reducing the risk for neural tubedefects in pregnant women. FDA explained its decision by stating that thesubmitted 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 foundin food are equally reliable in reducing the risk of neural tube defect birthsthan 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 offolic acid can be consumed with the variable amounts found in meats andvegetables. Also, he notes, storage and heating foods destroy folate levels. Hesaid he plans to sue in order to get this health claim ultimately approved.

However, FDA decided that, even though the claim was suggestive andinconclusive, the scientific evidence for the cardioprotective benefits ofomega-3 fatty acids outweighed those against it. FDA approved the followingclaim: "The scientific evidence about whether omega-3 fatty acids mayreduce the risk of coronary heart disease (CHD) is suggestive, but notconclusive. Studies in the general population have looked at diets containingfish and it is not known whether diets or omega-3 fatty acids in fish may have apossible effect on a reduced risk of CHD. It is not known what effect omega-3fatty acids in fish may or may not have on risk of CHD in the generalpopulation." This will replace the industry-suggested claim of"Consumption of omega-3 fatty acids may reduce the risk of coronary heartdisease," which FDA considered suggestive, inconclusive and misleading.

"An overwhelming amount of evidence from various studies certainlydemonstrates that omega-3 fatty acids [by themselves] have cardiovascularbenefits," said Bob Walker, vice president of sales and marketing atPharmline, a manufacturer of omega-3. He also said that there are ways to getaround this modified claim. "I think there needs to be more PR and betterconsumer education [on the industry's part]."

FDA explained in its Oct. 31 letter to Emord & Associates that researchwas conducted looking at people who consumed fish, and it is unknown whether thefish 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 AmericanHeart Association's advice to eat at least two servings of fish per week for itsomega-3's cardioprotective effects.

Emord said he and his clients were pleased to see FDA permit an associationwith omega-3 fatty acids and the reduction of heart disease. However, he said hewas disappointed that the agency will not allow this claim to be used on thefood omega-3 is derived from (fish). Also, the claim itself is "so wordyand so incomprehensible in the second and third sentences, that we think thatmost consumers will simply not understand what the agency is trying toconvey," Emord stated. As a result, he said that companies in the omega-3business plan to inundate the market with a consumer-savvy revised version ofthe 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 twograms, (preferably only one gram) per day so as to not exceed the upper intakelevel of three grams per day; the agency explained in its letter that this is asafety precaution, as every individual has different omega-3 baseline levels.

FDA postponed its decision on antioxidants' effects on cancer, citing newstudies, the amount of antioxidants and the various cancers were making itsdecision 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.