How ConsumerLab.com Serves the Sports Nutrition Industry. Quality and Identity for Supplements

Transcription

1 How ConsumerLab.com Serves the Sports Nutrition Industry. Quality and Identity for Supplements Mark Anderson, Ph.D., Vice President, Research ConsumerLab.com June 12, 2015, 8:30 AM Austin Hilton, Salon B

2 DISCLOSURE Mark Anderson, Ph.D. No conflicts to disclose. Information is based on independent Product Reviews funded by subscriptions to ConsumerLab.com. CL is an independent organization with no ownership from or in companies which make, distribute or sell health or nutrition products.

3 Who We Are Experts in health-product testing and consumer health information Tod Cooperman, M.D., President & Founder Consumer health expert with 19 years experience evaluating health services/products; Expert witness to Senate and House subcommittees regarding supplements Mark Anderson, Ph.D., V.P. Research Pharmacologist/toxicologist with 20 years experience in dietary supplement research; active member of AOAC International. Lisa K. Sabin, Vice President for Business Development Lisa Sabin joined ConsumerLab.com from Prevention Magazine.

4 Overview What Is ConsumerLab.com? Testing Programs Recent Findings for: Protein Powders Creatine Supplements Weight Loss Supplements Others Things to Check with Supplements

5 ConsumerLab.com MISSION: To identify the best quality supplement products through independent testing. Since 1999, the leading independent group evaluating and reporting on dietary supplements and nutrition products in the U.S. Over 3,500 products tested from over 400 brands. 75,000+ individual members; institutional subscribers include gov t, universities, hospitals, public libraries

6 QUALITY PRODUCT????

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8 Testing Programs Product Reviews Quality Certification Program Special Testing (for Clinical Trials) Raw Material Testing

9 Product Reviews Testing for Quality: Identity Quantity Purity & Freshness Disintegration Safety Label Claims Products selected by CL. Multiple samples purchased as a consumer would from retail, direct distributors, healthcare providers, etc. Pill disintegration tested in-house. Other tests sent to expert labs blinded. Confirmation of failures in second lab. Results published online for CL members, including latest clinical information and consumer tips. Test methods and approval criteria published online free to public at

10 Categories Reviewed -- Over 60 categories tested Examples B vitamins Calcium Cholesterol Lowerers CoQ10 Creatine/HMB/Glutamine DHEA Enzymes (lactase) Echinacea Garlic Ginkgo Ginseng Glucosamine/Chondroitin Iron Isoflavones Lutein/Zeaxanthin Magnesium Melatonin Milk Thistle MSM Multivitamins/Multiminerals Nutrition Bars Nutrition Powders Omega-3 & 6 fatty acids Probiotics Red Yeast Rice Resveratrol Saw Palmetto St. John s Wort Valerian Vitamins A, C, D, E & K

11 New Categories Aloe Arginine Ashwagandha Boswellia Curcumin Energy Drinks Ginger Gluten Horny Goat Weed N-Acetyl Cysteine Theanine Maca Rhodiola Yohimbe

12 Consumers Help Us Decide What to Test 2014 ConsumerLab.com Supplement Users Survey* * Based on sample of 10,326 readers of ConsumerLab.com e-newsletter. Shown are first 10 of 32 most popular categories. Respondents used 1,639 different brands.

13 Quality Certification Program Oldest 3 rd party dietary supplement certification program (started 1999) Allows consumer to identify additional high-quality products. Certified products are listed online. Only 3 rd party program to freely publish testing methods/criteria same as in our Product Reviews Stricter criteria than other programs, e.g., Prop 65 lead limit (0.5 mcg/day) vs. industry (10 mcg/day). Like other programs, manufacturer or distributor requests and pays for testing of a specific product Product can not be provided must be purchased on the market

14 What We Have Found One out of four supplements is poor quality* Herbals: Vitamins/Minerals: Other Supplements: Nutritionals/Other: 43% failed 21% failed 21% failed 20% failed *Of products selected by ConsumerLab.com

15 Test Results for Selected Sport Supplements

16 Protein Powders & Drinks Among 16 products selected, five failed testing: One was contaminated with lead (12.7 mcg per scoop) Two had more cholesterol than labeled and one contained 52% more sugar (12.2 g vs. 8 gm). One contained only 31.9% of its listed protein (7.3 g per scoop instead of 23 g)

17 Protein Powders & Drinks Protein analyses: To avoid counting free amino acids or other amine-containing compounds in the product as protein, High- Performance Liquid Chromatography (HPLC) analysis of both the hydrolyzed and unhydrolyzed sample was used. Dumas (combustion) and Kjeldahl methods cannot detect adulterants.

18 Creatine Among 13 creatine and creatine/bcaa products selected, all three liquid creatine supplements failed testing 2 contained less than 4% of the listed creatine and all were contaminated with creatinine. All creatine-only (and BCAA-only) powders passed testing. One combination powder failed for inadequate labeling. The cost to obtain 5 grams of creatine from a high-quality product ranged from just 9 cents to $1.36. ISSUE: Creatine is unstable in liquid. Powders are more stable, although prices range widely for similar amounts.

19 Garcinia cambogia (HCA) Among 13 supplements selected, only 6 contained the labeled amounts of HCA (hydroxycitric acid). HCA levels were 14% to 81% of expected amounts Those which claimed endorsement by Dr. Oz (which was false) were most likely to fail testing. Our results were used by Dr. Oz to get one product, Miracle Garcinia cambogia off the market. ISSUE: Hot and hyped supplements are more likely to have quality problems and to be sold by scam artists.

20 Green Coffee Bean Extract chlorogenic acids (CGA s) Among 8 supplements selected for testing, 4 did not contain expected amounts of CGAs. Failure levels included none detected, 6.2%, 28.9% and 40.6% CGAs. Caffeine levels ranged from as little as 4 mg to 82 mg per suggested serving. Profile of Chlorogenic acids Product With None Detected

21 Bilberry Anthocyanosides Among eight bilberry supplements selected for testing, one contained only 62.2% of the expected anthocyanosides of which most (85%) was a single compound (cyanadin 3-0-glucoside or kuromanin) a widely sold chemical. Several expected compounds were absent. This strongly suggests adulteration by spiking. Real Adulterated

22 Test Results for Other Related Supplements

23 Cocoa Powders Among 14 cocoa and chocolate products selected for testing, all natural cocoa powders (including two USDA certified organic ) were contaminated with cadmium and/or lead (23.7 mcg/ serving and 1.4 mcg/ serving) Found up to 35.3 mg/g cocoa flavanols. and 1 highly concentrated extract had virtually no flavanols an important polyphenol in cocoa.

24 Coconut Water Touted for rehydration, two of the three leading brandname products had far fewer electrolytes than listed. One had only 18% of the listed sodium the key electrolyte for rehydration. Another had only 59%. Magnesium levels were also lower than claimed (77% and 64%). Other than for potassium, products were not good sources of electrolytes, as promoted. Issue: Variation (+/- 20%) is permitted in naturally occurring food sources, but some manufacturers exceed this limit.

25 Vitamin D Among 23 products selected (including vitamin D/calcium supplements), two popular national products contained too much vitamin D (172.5% and 182.2% of listed amounts) an excessive overage. Too much vitamin D may be harmful. Two products failed USP 30-minute disintegration testing: One took 55 minutes and the other would not break apart even at 60 minutes, suggesting reduced absorption. A powder contained 1 to 2 mcg of lead per suggested serving (1 to 2 scoops). Lead should be avoided.

26 Glucosamine & Chondroitin Quality has improved over the years. Most recently, only two out of 15 products selected by CL failed: One had only 84.6% of its chondroitin sulfate and another failed to disintegrate within the 30 minute USP limit (taking 55 minutes). ISSUES: Glucosamine is made from crab shell, which can be contaminated with lead. Real chondroitin is expensive. Non-specific tests (e.g., CPC titration and size-exclusion chromatography) can be tricked by compounds that are not chondroitin. CL used a more specific method -- enzymatic HPLC.

27 Omega-3 and -6 Seed Oils (Flax, Borage, Others) Among 16 supplements selected for review, one supplement completely lacked the listed GLA a key omega-6 fatty acid. The distributor presented data to CL indicating that the capsules used in the product contained the listed GLA. Retesting of another bottle again showed no GLA. ISSUE: The manufacturer had filled the bottles with the wrong pills but was not testing the finished products, only capsules before bottling. ALSO: One supplement had none of the oils expected (from black currant seed). Why? It was currant fruit, not seed. Check labels for the plant part.

28 Red Yeast Rice Only three products provided the minimum dose known to be effective in lowering cholesterol, 5-18mg/total lovastatin per day. Lovastatin levels ranged across products from mg to 8.4 mg for the same 600 mg dose i.e., a product could contain several hundred times more active ingredient than another and the consumer would have no way to know. Citrinin, a potential kidney toxin, was found in one product from a major national food store. ISSUES: To avoid being an unapproved drug lovastatin amounts are not shown on labels, and contamination can occur.

29 SAMe (S-adenosyl-methionine) Among nine supplements selected, one contained no SAMe and another contained only 74.5% (the highest priced product). ISSUES: 1) SAMe is an expensive, unstable ingredient. Companies can increase margins by putting in less or buying low quality ingredient. In past, the inactive salt portion of molecule (~50% of weight) has been included in ingredient listing suggesting 2X the active amount. 2) Improper packaging can affect stability.

30 Most Common Problems Found Less active ingredient than expected (extract ratio only) Low quality or adulterated ingredient Contamination: Heavy metals, pesticides, manufacturing by-products, Spoilage, microbes Inadequate disintegration of pills More active ingredient than expected Inadequate labeling to describe ingredient (e.g., plant part) Unapproved label claims Other Issues: Insufficient suggested dosage; Nutrients exceeding Upper Tolerable Intake Levels (ULs)

31 GMPs: Are They Helping? Before GMPs (pre 2008): one 1 out of 4 supplements selected by CL failed testing. After GMPs ( ): 25% fail. Herbals: 43% Vitamins/Minerals: 21% Other Supplements: 21% Nutritionals/Other: 20% 65% of GMP inspections ( ) resulted in citations (Form 483) with an average of 7 problems. Most common: Failure to verify product specifications for a finished batch including identity, purity, strength and composition. Others include no master formula, no batch records, not verifying identity of ingredients.

32 Thank you