Claims That Can Get You in Trouble

Transcription

1 Claims That Can Get You in Trouble What s New in Advertising Claims for Dietary Supplements Steve Mister President & CEO, CRN

2 FTC Requirements for Advertising Claims must be truthful, not misleading and substantiated with adequate support Competent and reliable scientific evidence Applies to express and implied claims Flexible standard for evidence FTC also has authority to challenge unfair trade practices that cause or likely to cause substantial injury to consumers Sections 5, 12, and 15 of the FTC Act 2

3 Competent and reliable scientific evidence defined as tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area, that have been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results. 3

4 Lane Labs 2000 FTC case with LaneLabs for BeneFin and SkinAnswer FTC found Lane Labs to have misled consumers and required a consent decree Standard consent order admitted wrongdoing and promised not to sin again 4

5 The Consent Decree The decree forbade express or implied misrepresentations regarding the existence, contents, validity, results, conclusions, or interpretations of any test, study or research in connection with the manufacturing, labeling, advertising, promotion, offering for sale, sale, or distribution of any food, dietary supplement, or drug. Lane Labs must refrain from making any representation about the effect of [a] product on any disease or disorder, or the effect of such product on the structure or function of the human body, or about any other health benefits of such product, unless, at the time the representation is made, it possessed and relied upon competent and reliable scientific evidence that substantiates the representation. Classic fencing in language to prevent future violations 5

6 Fast forward to 2009 Lane Labs New FTC action against Lane Labs -- AdvaCal and Fertil Male FTC argued that LL violated the earlier consent decree, but NJ federal court held that scientific minds could differ studies presented were competent and reliable scientific evidence. FTC announced the standard consent order language would change! 6

7 New Consent Orders Claims must substantiated by at least two randomized, double blind, placebo-controlled clinical trials, Conducted by different researchers independently of each other, and Claims to treat or prevent disease must be approved by FDA through drug approval or OTC monograph 7

8 Kellogg s Rice Krispies Now helps support your child s immunity with 25 FTC Consent Order prohibits percent Daily Value of Kellog s from making claims Antioxidants about any health and benefit Nutrients of any Vitamins food unless A, B, the C, claims and E. are backed improved by scientific to include evidence antioxidants and not misleading. and nutrients that your family needs to help them stay healthy. 8

9 Nestlé's Boost Kid s Essentials Prevents upper respiratory infections Consent order requires Nestle to: stop claiming that BOOST will reduce the risk of colds, flu, and other upper respiratory tract infections unless the claim is approved by FDA, and the claim is backed by at least two well-designed human clinical studies. Protects against colds and flu by strengthening the immune system Reduces absences from daycare or school due to illness 9

10 POM Wonderful Backed by $25 million in The FTC complaint medical alleges: research. many of POM s Proven scientific to studies fight for did not POM lawsuit show against heart FTC disease alleges cardiovascular, benefit. new prostate substantiation the some standard of the is and invalid prostate erectile because: cancer health. studies it exceeds POM FTC s relied jurisdiction, on were Further neither proof blinded of heart nor is arbitrary controlled. and capricious, healthy and benefits it violates the the erectile First Amendment. dysfunction Clinical study studies POM prove. relied upon did not show that POM Juice was any more effective than a placebo. 10

11 Airborne & Store Brand Versions Reduce $26 million the risk in of fines or to Airborne prevent colds and flu Protect Store against brand cases or fight signal that retailers germs can t hide behind the brand s advertising Reduce the severity or duration Product of a manufacturers cold and ingredient suppliers may be liable too if they Protect originated against the colds claims and flu in crowded places Boost the immune system. 11

12 Cold MD Originally an NAD 94% case, Faster ended Recovery up with FTC and $5.5 Increased million judgment Immune Resistance by 312% Consent Order prohibits use of any Clinically Proven Results! disease claim unless approved by FDA Is lymphocyte proliferation a valid marker for cold symptoms? Claims must be supported by competent and reliable scientific evidence Are mice studies valid for rhinoviruses? Ingredient study vs. actual product Company may not misrepresent the results of any test or study Recall study of 61 elderly Chinese subjects 12

13 Would these claims fly today? 13

14 FDA Requirements for Labeling Claims Dietary Supplements may make nutrient content claims, structure/function claims, and with FDA approval, certain health claims. Supplements may not make claims to prevent, treat, cure, diagnose or mitigate a disease. Mfrs of dietary supplements must posses substantiation that any claims they make are truthful and not misleading 21 U.S.C. 343(r)(6). 14

15 Lipton Green Tea Website references four studies that showed a cholesterol-lowering effect with green tea FDA says that evidences the intended use is to treat disease That makes the product a drug! 15

16 Canada Dry Green Tea Ginger Ale "enhanced with 200 mg of antioxidants from green tea and vitamin C" FDA does not consider it appropriate to fortify snack foods such as carbonated beverages Wording does not comply with requirements for nutrient content claims see 21 C.F.R

17 National Advertising Division Part of the CBBB Reviews DS ads for truthfulness & substantiation Industry challenges and NADinitiated monitoring Issues complete decisions Refers noncompliant cases to FTC 17

18 Blockade Blocks and locks viruses cold NAD decision held that : from entering human Blocks viruses cells studies were not In vitro laboratory Works to target and block viruses sufficient to support before claims they multiply Acts before the Virus Can Attack -- Blockade works to target and block viruses before they can replicate A bioavailability study of 6 people was too The bioactive molecules in small to prove effect in general population Blockade seek out viruses, bind to them and create a coating around them. This coating is like a fence aroundwho the virus that blocks its the abilityflu Studies on people already had to attach to and enter cells. could not be extrapolated to flu prevention up to 100% success rate in inhibiting the entry of enveloped viruses (like influenza). 18

19 Disney Multivitamin Gummies Touts the Benefits of DHA for healthy brain and eye development Contains DHA 100 milligrams (mg.) vs. 100 micrograms (mcg.) 19

20 Reversitall Reduces the risk of heart disease, liver disease, Alzheimer s, cancer and diabetes Provides greater performance than resveratrol alone = 750 bottles of red wine Lacking data in humans No data that product keeps skin healthy and supple 20

21 I-flex Clinically effective joint relief Joint relief to 4 out of every 5 people Works faster than glucosamine Study result lacked statistical significance No comparative study was performed 21

22 GenFX Stimulate your body s own production of HGH The same results [as HGH injection] simply and affordably You become better at fighting diseases No research on the product itself, just the ingredients Benefits of HGH vs. demonstrated benefits of product Relevance of studies to the product 22

23 Santica In a recent study, 94% reported seeing results clinically proven to actually help reduce cellulite by helping promote healthy cell metabolism may lead to measurable reduction in your hips, thighs, abdomen and ankles can produce results without any changes in diet, exercise or lifestyle 23

24 Cognivin Improves mental performance and short term memory loss resulting from stress and aging Quickly boosts memory, learning and concentration Help reduce forgetfulness Improve mental focus Inhibit age-related cognitive decline Improve memory retention Reduce stress and anxiety Provide sustained energy Elevate mood 24

25 MegaRed Better, faster and more powerful than fish oil 3x better for supporting cardiovascular health Clinically show to support cardiovascular health No head to head comparison Different biomarkers at work 25

26 Prenatal Multi +DHA Combines a prenatal vitamin with DHA Reduces the risk of having a child with brain or spinal cord birth defects What about the interaction of DHA and folic acid in the body? 26

27 CRN s Roadmap for Retailers 27

28 Thank you Steve Mister Phone: (202)