Dietary Supplement Update

Transcription

1 Dietary Supplement Update Daniel Fabricant, Ph.D. Director, Division of Dietary Supplement Programs, Office of Nutrition, Labeling and Dietary Supplements, Center for Food Safety and Applied Nutrition, Food and Drug Administration 1 The Menu New Dietary Ingredient (NDI) guidance 21 CFR Part 111 cgmps Adverse event reporting (AERs) Tainted Supplements Other matters The take away Questions 1

2 NDI fun facts There are about 55,600 dietary supplement products on the market, and the Institute of Medicine has estimated that 1,000 new dietary supplements are introduced to the market each year, yet FDA has only received approximately 700 NDI notifications since we began reviewing NDI notifications some 16 years ago. More NDI fun facts We have acknowledged 158 of those notifications. An acknowledgement means that we do not object to the marketing of the ingredient in a dietary supplement under the conditions of use proposed in the notification. To date we have objected to 442 notifications. A number of objections still find their way onto the market. 2

3 NDI Guidance Under the FDA Food Safety and Modernization Act (FSMA), FDA is required to publish NDI guidance not later than 180 days after the date of enactment. The guidance is intended to inform and assist manufacturers, distributors, and other industry entities in deciding when a premarket safety notification for a dietary supplement containing a new dietary ingredient (NDI) is necessary and in preparing premarket safety notifications. 3

4 NDI guidance Guidance represents the FDA's current thinking on this topic. It does NOT create or confer any rights for or on any person and does not operate to bind FDA or the public. 21 CFR Part 111 Official Action Indicated 25% for FY10 Letter to Industry- December 15, 2010 ( ResourcesForYou/Consumers/ BuyingUsingMedicineSafely/ MedicationHealthFraud/UCM pdf) New Food GMPs Preventive Control/HACCP (Sec. 103) & Intentional Adulteration (Sec. 106) 4

5 Number of CAERS cases (individuals)^ consuming dietary supplements and experiencing an adverse event January 1, 2007 through December 31, 2010 Number of CAERS Cases Year From Voluntary Reports From Mandatory Reports $ Both Voluntary and Mandatory Reports Total Cases Per Year * Total Cases Per Report Type ^For , counts were obtained using FDA Received Date and year of first report for a case if there were multiple reports for a case (e.g., both a voluntary report and a mandatory report; follow-up reports); CAERS was searched on May 26, 2011 for these counts; *There were two cases with a voluntary report in 2007 that also had information submitted under a mandatory report; one in 2009 and one in $-Submission will not be construed by FDA as an admission that the dietary supplement involved caused or contributed to the adverse event being reported. Soladek Received seven reports of serious health problems occurring in consumers using the product. The problems include decreased renal function, elevated levels of calcium in the blood, fatigue, heart arrhythmia, vomiting, and diarrhea. Symptoms of vitamin D toxicity include weakness, fatigue, headache, nausea, vomiting, diarrhea, changes in mental status, increased blood pressure, abnormal heart rate or rhythm, kidney damage, and coma. Symptoms of vitamin A toxicity include anemia, anorexia, alopecia, joint pain, bone weakness, bulging eyes, liver abnormalities, and birth defects. Other related products 5

6 Serious Health Risks In the past few months, there have been reports in all three high risk product categories of serious adverse events including two deaths. Health risks are compounded by false and misleading marketing: Undeclared ingredients -- at times, up to 10 times the recommended starting doses False claims to be natural, herbal, or safe Inadequate or absent safety warnings Hidden ingredients may interact with other medications a consumer may be taking Poor manufacturing quality controls Professional careers adversely affected by positive drug tests (e.g. amphetamines, anabolic steroids) police, firefighter, military, athletes 11 Hidden Ingredients Prescription drug ingredients, including controlled substances Analogues of prescription drug ingredients Unapproved scheduled controlled substances Ingredients with an IND and under clinical investigation Novel ingredients that have never been studied in humans Ingredients approved as drugs in other countries Ingredients that have been removed from the US market for safety reasons 12 6

7 Weight Loss Products More than 40 recalled products Consumer alerts concerning more than 70 products Hidden Ingredients: sibutramine controlled substance and obesity drug bumetanide a potent diuretic fluoxetine an antidepressant rimonabant not approved for marketing in US cetilistat an unapproved experimental obesity drug fenfluramine stimulant drug withdrawn from US market propranolol beta-blocker drug Examples: Slim 30 SoloSlim Que She 2 Day Diet StarCaps Venom Hyperdrive 13 Masquerades as Legitimate Supplement 14 7

8 Sexual Enhancement Products More than 70 recalled products 4 consumer warnings Hidden Ingredients: sildenafil erectile dysfunction drug (Viagra) tadalafil erectile dysfunction drug (Cialis) vardenafil erectile dysfunction drug (Levitra) piperidenafil analogue of vardenafil sulfoaildenafil analogue of sildenafil benzamidenafil - a newly discovered PDE5 inhibitor Examples: Erectzia Vigor 100 Aziffa Mojo Zotrex Zilex Prolatis 15 Masquerades as Legitimate Conventional Food 16 8

9 Body Building Products More than 90 recalled products A public health advisory issued about certain body building products Steroid Ingredients: Many products contain undeclared listed anabolic steroids Aromatase inhibitors estrogen blockers Prohormones and SARMs Long chemical names that are confusing to consumers: Ø 19-Norandrosta-4,9-diene-3,17 dione Ø 17α-methyl-etioallocholan-2-ene-17b-ol Ø 4-hydroxyandrostenedione (4-OHA) Ø 2α,3α-epithio-17α-methyl-17β-hydroxy-5α- etioallocholane Ø Androsta-1,4-dien-3,17-dione Examples: TREN-Xtreme Straight Drol Epi-Tren ESTRO Xtreme Methadrol Reversitol Rage RV5 17 Masquerades as Legitimate Supplement 18 9

10 Tainted Supplement Pathway to Market FOREIGN DOMESTIC Finished Product Raw Material U.S. Border Importer Contract Manufacturer(s) (bottler, labeler, ingredient manufacturer, encapsulator) Niche/Community Distributors Own Label Distributors Large Distributors Consumer Notable Recent Actions 2011 Recalls and Alerts U-Prosta prostate health contained undeclared terazosin (FDA drug for BPH) Black Ant sexual enhancement sildenafil (Viagra) Svelte 30 weight loss sibutramine Extenze counterfeit tadalafil and sibutramine Celerite weight loss sibutramine Nite Rider sexual enhancement sildenafil Fruta Planta weight loss sibutramine Passion Coffee sexual enhancement analog of sildenafil Rock Hard Extreme sexual enhancement analog of sildenafil STUD capsules sexual enhancement analog of sildenafil Regenerect Sexual enhancement- analog of sildenafil 20 10

11 Notable Recent Actions Recent Criminal Prosecutions: In early 2010, VMG Global pleaded guilty to a corporate felony and was fined for selling anabolic steroids under the names Tren Xtreme, Mass Xtreme, and others. In December, Mimi Trieu pleaded guilty to an 18 count indictment charging her with the illegal importation and distribution of more than four million diet pills that contained a controlled substance, unapproved drugs, and a possible carcinogen. In January, a man from Kunming China pled guilty to charges relating to trafficking counterfeit versions of the weight loss drug Alli, as well as unapproved weight loss related drugs marketed in the US as dietary supplements. In early February, several individuals were charged with the misbranding and dispensing of steroids sold as dietary supplements 21 Notable Recent Actions Consumer and Industry Outreach Early March New tainted weight loss supplement videos Widget Weight loss fraud website

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13 Other Issues Recalls Antibiotic dietary supplements NTP/NCTR Aloe Other ingredients 26 13

14 Other Issues Conventional Food/Dietary Supplement Regulatory Line Melatonin products Liquid DS Guidance Pesticides 28 14

15 Thanks OCRA Board CDER: Brad Pace; Elizabeth Miller CFSAN: Bob Moore ORA: Gary Coody Questions? 15