1. Claims – Consumer Perspective David Schardt Center for Science in the Public Interest (CSPI)

2. 3 kinds of health-related claims: health claims structure/function claims nutrient content claims

3. Health claims characterize the relationship of any substance to a disease or health-related condition Requires significant scientific agreement based on the totality of publicly available information

4. Legal health claim Diets low in saturated fat and cholesterol and rich in fruits, vegetables, and grain products that contain some types of dietary fiber, particularly soluble fiber, may reduce the risk of heart disease, a disease associated with many factors.

5. Illegal health claims How Lifeway Kefir Helps You Autoimmune Disorders: Helps manage or alleviate symptoms. Crohn’s and Colitis: Reduces the severity of symptoms, lessening abdominal pain, diarrhea and nausea. Yeast Infections: Several studies show that Kefir can reduce both the number and severity of yeast infections. http://www.lifeway.net/HealthWellness/HowKefirHelpsYou.aspx

6. Qualified health claim Very limited and preliminary scientific research suggests that eating one-half to one cup of tomatoes and/or tomato sauce a week may reduce the risk of prostate cancer. FDA concludes that there is little scientific evidence supporting this claim.

7. Structure/function claims Describe the role of, or characterize the mechanism by which a nutrient affects a body structure or function

13. Health claims FDA has approved only 12 health claims and about 20 qualified health claims

14. Structure/function claims Thousands of structure/function claims on foods and dietary supplements All legal claims for probiotics are structure/function claims

15. Manufacturers can say almost anything they want in a S/F claim, short of a disease claim. They’re supposed to have substantiation But there are no requirements about the kinds of evidence a company is supposed to have

16. No requirements about providing that evidence to FDA FDA does not have the authority to demand the evidence FDA does not review the basis for S/F claims

17. Industry controls structure/function claims, not FDA Little wonder why it likes them Cheap, easy to do, no accountability AND Consumers think S/F claims are just as good as health claims

18. FOOD LABELING FDA Needs to Reassess Its Approach to Protecting Consumers from False or Misleading Claims GAO January 2011 GAO-11-102

19. According to research conducted by FDA, the International Food Information Council, and academia, “consumers have difficulty distinguishing among the many different types of claims on food labels, including health claims, qualified health claims, structure/function claims, and nutrient content claims.”

20. According to a 2008 industry study, “consumers rate the level of scientific evidence and other attributes associated with a product containing a structure/ function claim as similar to the evidence and other attributes of health claims with significant scientific agreement on a product.”

21. “consumers are just as likely to purchase a product with a structure/function claim, which FDA does not review, as they are to purchase a product with a health claim supported by significant scientific agreement, which FDA does review.”

22. “structure/ function claims were perhaps the most popular of all the claims the council tested: Most consumers liked their brevity and general health messages more than health claims, which they saw as too wordy and too disease specific.”

23. Diets low in saturated fat and cholesterol and rich in fruits, vegetables, and grain products that contain some types of dietary fiber, particularly soluble fiber, may reduce the risk of heart disease, a disease associated with many factors. vs “promotes a healthy heart”

24. “consumers find it difficult to understand the degree of scientific support for qualified health claims on food labels.”

25. “none of the tested language, whether appearing in real or fictitious product advertisements, communicated serious limitations in scientific evidence. In addition, consumers interpreted all of the tested advertisements in a disparate fashion.”

26. If S/F claims were truthful and not misleading, this wouldn’t be such a problem • Based on small, preliminary unpublished studies • Studied in clinical populations • Using different formulations • And different dosages • Looking at markers of unknown significance • Sometimes, the research shows the product doesn't work as claimed

27. Probiotics have an additional problem: Manufacturers don’t have to disclose which strain(s) they use in their products Or how much they use