Several legal and regulatory developments in 2016 had a major impact on the dietary supplement industry in the United States. Among the most pivotal were a 102-page draft new dietary ingredient (NDI) guidance, a Federal Register notice on the ingredient known as vinpocetine, and an FTC consent decree entered by Herbalife Ltd.
To understand the ramifications of the FDA guidance, one must start with DSHEA, the 1994 Dietary Supplement Health and Education Act. In the law, the 103rd U.S. Congress laid out a requirement that manufacturers or distributors notify FDA 75 days in advance—and provide the agency safety-related information—before marketing an NDI in a supplement.
In August 2016, FDA published new draft NDI guidance, which supplanted a 2011 document and represents the agency’s thinking on the NDI notification (NDIN) requirements under the law. As the comment period closed Monday, Dec. 12, final comments poured in to FDA from major trade associations and other esteemed institutions, underscoring the document’s significance.
That the industry has devoted so much ink to the 2016 draft NDI guidance is arguably a pleasant departure from the previous year’s hullabaloo, when the industry was the target of public scrutiny after New York Attorney General Eric Scheiderman accused four supplement retailers of fraud.
On the heels of Schneiderman’s herbal supplements investigation, the mainstream media, state attorneys general and other critics called for reforms to DSHEA and stronger FDA oversight of supplements.
Generally, the 2016 NDI draft guidance hasn’t produced sensational headlines that call into question the integrity of supplements. But the new document is complex and controversial, posing challenges to an industry that is striving to balance investments in innovation and regulatory compliance.
“It is important to stress our concern that some of FDA’s views and requirements laid out in this guidance will act as deterrents to increased compliance because of the vastly increased costs triggered by an inappropriate and unfounded expansion in the scope of products subject to NDIN requirements," said Loren Israelsen, president of the United Natural Products Alliance (UNPA), in comments filed Dec. 12 with FDA. “That said, we also hasten to add our agreement with FDA on other issues contained within the guidance which we believe support the mission of public health and safety for dietary supplements."
Steven Tave, acting director of FDA’s Office of Dietary Supplement Programs, has described the notification process as the “only pre-market opportunity the agency has to identify unsafe supplements before they are available to consumers."
FDA rarely takes enforcement action to remove a supplement from the U.S. market unless it has concerns that an ingredient is unsafe. That fact may help to explain the industry’s consternation upon learning in a Sept. 7, 2016 Federal Register that FDA was considering prohibiting vinpocetine from supplements.
Some industry leaders blasted FDA for reversing its position on the legality of the ingredient several years after the agency received five NDI notifications on vinpocetine without objecting to any of them.
In the Federal Register notice, FDA tentatively determined vinpocetine does not qualify as a dietary ingredient and is excluded from the definition of a dietary supplement. Supplement leaders expressed concerns that FDA’s position—if made final—was inequitable and would undermine confidence in the NDIN process, discouraging innovation.
Another 2016 supplement-related development worthy of highlighting is Herbalife’s recent settlement with federal regulators. In 2014, more than a year after the billionaire Bill Ackman accused Herbalife of exploiting minorities and operating an immense pyramid scheme that was doomed to fail, FTC confirmed opening an investigation into the multi-level marketing (MLM) company.
Under an FTC consent decree announced in July 2016, Herbalife agreed to pay US$200 million and change a number of its business practices. The agreement could function as a roadmap for changes in the broader $36 billion direct selling industry, and perhaps over the long term give investors greater confidence in the legitimacy of Herbalife and its MLM brethren.