Back in 2015, an investigation by the New York Attorney General’s office revealed that many dietary supplements contain ingredients that aren’t found on the label. That could all change thanks to an overhaul by the U.S. Food and Drug Administration’s oversight of the supplement industry.
The FDA said Monday that it is setting up new ways to quickly inform the public when there’s concern about an illegal or potentially dangerous ingredient, updating how it evaluates new dietary ingredients coming on the market, and creating new enforcement strategies. According to the agency, it’s all part of a bid to protect the consumers who use the vitamins, minerals, and herbs that fall within the dietary supplement industry, but the move could also help the pharmaceutical companies that make rival products. In a statement, FDA Commissioner Scott Gottlieb called the effort “one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years.”
The federal Dietary Supplement Health and Education Act, which regulates the manufacture and labeling of dietary supplements, was enacted in 1994, and hasn’t been overhauled since, although the FDA did create the Office of Dietary Supplement Programs three years ago. As dietary supplements have mushroomed into what the FDA says is a $40 billion industry comprising more than 50,000 unique products, it’s hard to argue that some oversight is not needed.
Globally, supplements are a $128 billion business, according to Nutrition Business Journal 2017 data, and a good chunk of that is in the United States, where three out of every four American consumers take a dietary supplement on a regular basis. The business is getting even bigger as more and more companies try to cash in on the $3.7 trillion wellness industry. While no one seems entirely sure how to define wellness (soundbaths? regular baths? high end floss? aromatherapy?), supplements are certainly part of the equation, even when they are devastating for the environment and may not actually work.
The FDA is hoping to crack down on spurious claims made by supplement companies. To kick off the campaign, it sent 12 warning letters and five online advisory letters to companies making and selling supplements that claim to prevent, treat, or cure diseases like Alzheimer’s, and health conditions, including diabetes and cancer.
Here are the companies that got warning letters:
- John Gray’s Mars Venus LLC: Products include 2-AEP Membrane Complex, Ionic Silver Water, L-Glutathione, Liposomal DHA – Ultimate Omega-3 Brain Support, Liposomal Methyl B12/Folate, NAC N-Acetyl-L-Cysteine, and Vectomega).
- TEK Naturals: Products include BURN4Her, BurnerTEK, Mind Ignite, TEK Male, and TestoTEK.
- Pure Nootropics, LLC: Products include Vitamin D3 5000 IU, Turkey Tail Mushroom Powder, and Ginkgo Biloba Capsules.
- Capris Associates Inc. / BR Naturals: Products include Avocado Oil, Black Seed Oil, Moringa Powder, Premium Olive Oil D.O.P., Pumpkin Seed Oil, and Unrefined Coconut Oil.
- Nutrition Coalition Inc: Products include Alpha-Lipoic Acid, Colostrum Alpha Whey III (Liquid), Colloidal Silver, CoQ10, Curcumin, Echinacea Root, Liva-Vite, L-Carnitine, Milk Thistle, Selenium, Ultimate Willard’s Water Lotion with Goat’s Milk, Vinpocetine, Vitamin B Complex, Vitamin C, Vitamin D3, Vitamin E, and Willard’s Water.
- Gold Crown Natural Products: Products include New Ultra Colostrum, Melatonin with Valerian, Anamu & Llanten, and Circulation Max.
- Sovereign Laboratories, LLC: Products include Colostrum-LD, Viralox, and Curcumin-LD.
- Earth Turns, LLC: Products include Green Tea Extract, Cogni-Flex, GlucoFit 48mg, Fundamental D3 1000, and Fundamental Omega-3.
- DK Vitamins: Products include Green Tea Extract, Cogni-Flex, GlucoFit 48mg, Fundamental D3 1000, and Fundamental Omega-3.
- Emmbros Overseas Lifestyle PVT LTD: Products include Morpheme Remedies Arthcare Plus, Morpheme Remedies Cinnamon, Morpheme Remedies Diabeta Plus, Daily Vital Multivitamin, Morpheme Remedies Fenugreek, Morpheme Remedies Garlic, Morpheme Remedies Guduchi, Morpheme Remedies Memocare Plus, Morpheme Remedies Mind Plus, Morpheme Remedies Mucuna Pruriens, Nourish Vitals Seed & Fruit Mix, and St. Botanic Fish Oil.
- Peak Nootropics LLC (aka Advanced Nootropics): Products include Adrafinil, Aniracetam, Bacopa Monnieri, L-Dopa, L-Theanine, Noopept, Oxiracetam, Phenibut, Phenylpiracetam, Piracetam, Rhodiola Rosea, and Uridine.
- Blue Ridge Silver: BLUE RIDGE SILVER Colloidal Silver products.