FDA Announces Plans to Tighten Oversight of Dietary Supplements; Issues Warnings to 17 Companies

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For Presence Marketing Newsletter, March 2019
By Steven Hoffman

In what Food and Drug Administration (FDA) Commissioner Scott Gottlieb called “one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years,” FDA on February 11 announces plans to strengthen its oversight of the dietary supplements market.  

“In the 25 years since Congress passed the Dietary Supplement Health and Education Act (DSHEA), the law that transformed the FDA’s authority to regulate dietary supplements, the dietary supplement market has grown significantly. What was once a $4 billion industry comprised of about 4,000 unique products, is now an industry worth more than $40 billion, with more than 50,000 – and possibly as many as 80,000 or even more – different products available to consumers,” Gottlieb said in a statement.

According to FDA, the use of dietary supplements, such as vitamins, minerals or herbs, “has become a routine part of the American lifestyle.” Three out of every four American consumers take a dietary supplement on a regular basis. For older Americans, the rate rises to four in five. And one in three children take supplements, either given to them by their parents or, commonly as teenagers, taking them on their own, the agency said. 

Commissioner Gottlieb’s statement acknowledged the widespread use of supplements and also that “most players in this industry act responsibly” under the regulatory framework that exists under current law. He also said, however, that “bad actors” have been able to “exploit the halo” created by good companies, and so have been able to distribute and sell potentially dangerous products that put consumers at risk.

“As the popularity of supplements has grown, so have the number of entities marketing potentially dangerous products or making unproven or misleading claims about the health benefits they may deliver,” Gottlieb said. 

Under the new policy, FDA is developing a “rapid-response tool” to alert the public to avoid buying products that may contain unlawful or potentially dangerous ingredients. The agency also is looking to update its compliance policies with new dietary ingredient notifications (NDIs), which requires manufacturers to alert the FDA of any ingredients that weren’t sold in the U.S. before 1994.

“An effective NDI notification process represents the FDA’s only opportunity to evaluate the safety of a new ingredient before it becomes available to consumers and helps promote transparency and risk-based allocation of resources,” Gottlieb said.

FDA also is creating the Botanical Safety Consortium, a partnership between the public and private sectors, to evaluate the safety of botanical ingredients and mixtures in supplements.

“As we celebrate in 2019 the 25th anniversary of the passage of DSHEA, AHPA shares Commissioner Gottlieb’s vision…of finding the right balance between preserving consumers’ access to lawful supplements, while also protecting the public from unsafe and unlawful products and holding accountable companies that are not in compliance with the law,” Michael McGuffin, President of the American Herbal Products Association (AHPA), said in a statement. “AHPA has previously communicated specific suggestions for regulatory improvements to FDA and we look forward to a robust and transparent discussion on how best to serve Americans who include supplement products in their families’ health care choices,” he said.

Regarding NDIs, McGuffin added, “AHPA has invested significant resources to assist industry in submitting NDI notifications that meet the statutory requirements to bring a new ingredient to market. We have also submitted thoughtful comments to FDA’s prior draft NDI guidance documents and will continue to provide input so that any eventual guidance is both useful to the trade and does not stray from FDA’s statutory authority.” 

Under its tightened regulations, FDA also is hoping to make enforcement processes easier, which allows employees to issue warnings to companies and consumers. The agency on February 11 rolled out part of its plan when it sent warning letters to 17 companies for “illegally selling” products that it said claim to treat Alzheimer’s disease.

“I’ve personally benefited from the use of dietary supplements and, as a physician, recognize the benefits of certain supplements as a part of a comprehensive care plan,” Commissioner Gottlieb said. “It’s clear to me that dietary supplements play an important role in our lives as we strive to stay healthy. It’s also clear that the U.S. Food and Drug Administration plays an important role in helping consumers make use of safe, high-quality dietary supplements while also protecting Americans from the potential dangers of products that don’t meet the agency’s standards for marketing.”