Published on June 6th, 20190
The FDA’s Supplement Problem
At a recent public hearing hosted by the FDA, speakers described DSHEA (pronounced duh-shea) as “generally broken,” “not consistently great,” and “a paper tiger” when it comes to giving the FDA the enforcement tools it needs to effectively regulate the $40 billion supplement industry to ensure the safety and efficacy of products.
Critics say DSHEA is ill-equipped to handle an industry that, according to one estimate provided by the FDA at the meeting, is 10 times larger than when the law was passed in 1994. Currently, three in four Americans use supplements, according to the FDA, and the industry continues to grow.
“The realities of today’s marketplace demand a renewed approach to regulation,” Acting FDA Commissioner Ned Sharpless acknowledged in his opening remarks at the public hearing, titled “Responsible Innovation in Dietary Supplements.” “Now is the time to modernize our program to ensure better alignment with the realities of today’s dietary supplement market.”
Just how far is DSHEA lagging behind? Sharpless said the meeting was part of an effort to bring supplement regulation “into the 21st century.”
Diagnosing the problem
Unlike prescription drugs, the FDA does not have the authority to review supplements before they are sold to consumers, which no doubt has contributed to the industry’s explosive growth in the last 25 years. Under DSHEA, the FDA relies on supplement companies to let the agency know when they are about to debut a new product, a self-reporting process that many say is broken.
Several speakers at the public hearing noted that the FDA’s only opportunity to assess the safety and effectiveness of a supplement before it hits the market is through a New Dietary Ingredient Notification, or NDIN. Steve Tave, director of the office of dietary supplement programs at the FDA, called it “the final threshold.”
The problem is not all supplements require an NDIN and of those that do, it is believed that many choose not to file. (There’s also a workaround, which we’ll get to in a minute.) As a result, Tave said the FDA has received only 1,000 NDINs since 1994, during which time the number of supplements on the market has swelled from 4,000 to 80,000, according to the FDA.
The workaround to filing an NDIN is to submit a Generally Recognized as Safe (GRAS) notice to the FDA. The concern with these notices is that supplement companies are effectively doing the FDA’s job by affirming that the ingredients in their products are safe without any input from the agency before the products are in the hands of consumers.
Not surprisingly, it’s a job that supplement companies don’t seem to mind doing. Laura MacCleery, policy director at the nonprofit Center for Science in the Public Interest, said in her remarks that there have been six to seven times more GRAS notices than NDINs since DSHEA became law. The FDA says it reviews and responds to GRAS notices — and can conclude that the application “does not provide a sufficient basis for a GRAS determination” — but the process can take months, if not more. Meanwhile, the supplement remains on the market.
In addition, Ashish Talati, a partner at Amin Talati & Upadhye, said the loophole has a loophole in that GRAS notices do not require documentation of the ingredient actually being “sold and marketed to consumers.” It can just appear in a cookbook, he said. In fact, GRAS applicants need only show that the substance is generally recognized as safe among qualified experts or that the substance doesn’t fit the definition of a food additive that would require premarket approval by the FDA.
Differing opinions on a “DSHEA 2.0”
While some say the supplement industry has not accepted its responsibility to ensure products with harmful ingredients are prevented from reaching consumers, the industry warns against a future in which a “DSHEA 2.0” further hinders innovation.
Andrew Shao, interim senior vice president of scientific and regulatory affairs at the Council for Responsible Nutrition, the supplement industry trade group, said there’s already a disincentive for companies to file NDINs due to a lack of data protections that leaves proprietary information vulnerable to copycat products.
So until there is an incentive to provide premarket notification to the FDA, such as the threat of enforcement action, it will continue to be the Wild West as far as the marketing of supplements is concerned.
Find more of our coverage on supplements here.