FDA Warns Dietary Supplement Makers: Be Safe and Legal

Green tea pills (Getty Images/Alobeti)

In February 2019, the Food and Drug Administration (FDA) sent letters to twelve dietary supplement companies warning them of their illegal marketing of products that claim to prevent or cure serious diseases, including Alzheimer’s, or provide substantial health benefits, especially in weight control.

The letters and five online advisories the FDA posted online will affect green tea products, both their production, safety, labeling and marketing. Green tea is growing in popularity as scientific research begins to confirm the medical value of its antioxidants, especially the “magic molecule” Epigallocatechin gallate (EGCG). While green tea is mostly consumed as a drink, supplements are increasing at a faster rate.  The issue the FDA’s announcements are raising is how to ensure the pills and powders are as safe as the leaf, and responsibly marketed.

Green tea was the specific concern in one of the dozen letters. The firm specializes in natural supplements for personal care and emphasizes on its site that it is “a moral and honest company.” The FDA regards it as a misleading one and picks out as questionable and hence illegal such statements as “Green tea may also help to reduce the occurrence of Alzheimer’s disease.” The FDA’s commissioner, Scott Gottlieb, MD., stresses that its plans to modernize and enhance its oversight of supplements is targeted at misbranding and consumer safety. “I’ve personally benefited from the use of dietary supplements and, as a physician, recognize the benefits of certain supplements,” but, “Simply put, health fraud scams prey on vulnerable populations, waste money and often delay proper medical care.”

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Supplements have been a regulatory problem for the FDA for decades in that they are legally sold as a food and thus fall outside the strict requirements of pharmaceutical testing and certification but more and more of them are bought for their perceived medical value. Here, the FDA has no authority to test and certify the accuracy of the claims. It can respond only after a supplement hits the market and take action if there is evidence of adulteration or harm.

Of particular concern is the unreliability and even absence of accurate labeling of ingredients. There are no known adverse impacts of green tea drinking and supplements are safe except where the levels of EGCG and catechin compounds are hepatotoxic, meaning they cause very severe and even fatal liver damage. The European Food and Safety Authority, Health Canada, and Norway’s Mattilsynet safety agency have all moved to require warnings on green tea labeling. There are headline news reports of cases of overdosage. Studies show that many products contain no indication of concentrations of potentially dangerous ingredients.

The problem is not the supplements; they are safe. It is that the lack of oversight permits fraud and irresponsibility. Consumers take safety on trust and lack knowledge, information and protection. The dietary supplement industry continues to expand beyond easy monitoring. 3 out of every 4 US adults takes a supplement on a regular basis. For older people, the figure is 4 in 5, and 1 in 3 for children. The FDA reports that when the Federal legislation now in effect was passed in 1994, this was a niche market of $4 billion and is now a $50 billion business of 80,000 products.

While there are many sceptics about the likelihood of the FDA’s initiative leading to comprehensive change, they applaud its bringing the concerns to wider public attention. “We as a society hold drug manufacturers to extremely high standards, requiring extensive proof of efficacy and safety.” It’s time for this to include dietary supplements.

Sources: , FDA, Everyday Health

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