Urge the FDA to use clinical trials and NOT DEATHS as a measure of supplement safety.

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Urge the FDA to use clinical trials and NOT DEATHS as a measure of supplement safety

Every year, more than 20,000 people go to the emergency room because of nutritional supplements. Roughly 155 deaths were blamed on ephedra, a stimulant used in a variety of supplements, before it was finally banned by the FDA in 2003. An herbal supplement called kratom that is used as a pain remedy has been blamed for at least 44 deaths since 2011 but is still on the market. More than 3,000 supplements are recalled each year .

As a physician who has seen several patients suffer the side effects of supplements, I was shocked to learn that the dietary supplement industry is virtually unregulated with none of the safeguards in place for food, beverages, over-the-counter and prescription drugs.

·         Dietary supplement manufacturers do not need to register their products with the FDA, get FDA approval, or show evidence that their product is effective or even safe prior to offering it for sale.  As a result, dangerous supplements are removed from the market only after they have caused harm.

·         Manufacturers can put virtually any claim on a supplement, without any requirement to provide persuasive clinical evidence, as long as it’s accompanied by the warning: “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.”

·         There is no standardization of active ingredients or mandatory purity guarantees.

·         The FDA did gain the power to inspect supplement manufacturing in 2008, finding problems like poorly measured ingredients, dirty manufacturing equipment, pesticides in herbal products, and contamination with illegal prescription medicines in 70% of supplement manufacturing facilities over five years, but the agency still has no power to prevent the release of unsafe or ineffective products to the market.

·         Fraud is common, even with the most recognized brands.  In 2013, New York Attorney General Eric T. Schneiderman found that only 1 in 5 products tested at Walgreens, Walmart, Target, and GNC contained DNA from the plants advertised on the label. 

These issues are a direct result of the Dietary Supplements Health and Education Act of 1994, a law that supplement manufacturers helped write and pass.  Reversing years of policy under which supplement manufacturers had to demonstrate the safety of their products before the FDA approved the products for sale, the law allows supplements to go directly to market and carry unfounded health claims. If a given product later proves to be harming consumers, the burden is on the FDA to prove that the product is unsafe and then take the producer to court.

I’m Dr. Sreek Cherukuri, and I am calling on you to urge the FDA to take steps to protect all American consumers from an industry shown to be selling products they know are at best, ineffective, and at worst, truly harmful. I propose common-sense basic regulation to safeguard the consumer and prevent fraud:

·         All supplement manufacturers must register with the FDA.

·         Every manufacturer must provide the FDA with a copy of their label as well as a list of ingredients.

·         Manufacturers must show their products are safe for human consumption.