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FDA Launches Dietary Supplement Working Group

Posted by Marianne C. LeBlanc

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Who hasn’t seen weight loss pills, herbal vitamins, protein powder and other supplements while grocery shopping? They are a staple of American life. Over the past 25 years, the dietary supplement market has grown from a $4 billion industry to $40 billion. But U.S. Food and Drug Administration (FDA) regulation has failed to keep up. There is so little oversight that the supplements you buy at the grocery store may not be tested or safe, or they may do nothing at all.

In 1994, Congress passed the Dietary Supplement Health and Education Act (DSHEA), a first of its kind statute to regulate supplements. The law imposes some labeling and manufacturing requirements, and allows the FDA to take harmful products off the market. Those meager requirements are where the regulation stops.

Since the enactment of DSHEA, however, the dietary supplement market has continued to grow substantially. At last, on February 11, 2019, the FDA announced a new “Dietary Supplement Working Group.” The group’s mission is to modernize regulation of the booming dietary supplement industry.

If I Buy It At The Grocery Store, Isn’t It Safe?

Not necessarily. The current law only allows the FDA to stop the sale of a dietary supplement if they can prove the ingredients are harmful, an after-the-fact regulation.

The FDA’s website states: 

“Federal law does not require dietary supplements to be proven safe to FDA's satisfaction before they are marketed.”

The FDA cannot act until after a product is brought to market, and then reported to the FDA as potentially harmful. The harm must then be substantiated “as resources permit.” In other words, if the FDA can get to it.

This means the products can make it to grocery store shelves, be sold online through retailers like Amazon, and incessantly promoted on Instagram, Facebook, and Twitter, long before users may be made aware of the risks. The law does not require the product to be proven safe, nor that the claimed benefits are accurate, such as “all natural” or “aids in weight loss”.

The reason for this rather lackadaisical oversight is that Congress has defined these supplements as a food group. They are not subject to the same rigorous vetting process as drugs. Instead of needing scientific research and pre-approval like prescription and drug store medicine, supplements can only be reviewed when “adulterous” activity is reported to the FDA.

Dietary Supplements Found to Contain Banned Ingredients and Prescription Drugs

There is essentially no way to know what is actually contained in a dietary supplement. Only after a bad event has occurred will the FDA test it – after it has caused serious harm or even consumer deaths.  

With 50,000–80,000 different products on the market, there is a large opportunity for bad actors to distribute their products with mislabeled ingredient lists.

Among the most frightening are supplements with extra ingredients, which are not labeled and not communicated to the consumer. Some supplements promoting weight-loss have been found to contain sibutramine, which is banned in the United States for risk of heart attack and stroke.

Other products illegally contain prescription drugs. This endangers consumers, who are put at risk for anything from unexpected side effects to potentially fatal interactions with other drugs.    

What Can Consumers Expect From the FDA In The Future?

The FDA has pledged to crack down on the massive industry, and has acknowledged that the growing market has exceeded the FDA’s ability and authority to protect the public. The FDA plans to modernize how it regulates the tens of thousands of supplements sold today.

For more information on the proposed modernization, the FDA will be holding a public meeting on May 16, 2019 to foster a collaborative discussion on how to better their oversight of the industry. The meeting will be held at the FDA Center for Food and Safety and Applied Nutrition in Maryland.

For assistance with injuries involving consumer products, contact us. SUGARMAN’s personal injury attorneys have experience in product liability cases. Call us at 617-542-1000, email info@sugarman.com, or fill out a Contact Form.