Developing treatments for Alzheimer’s disease has been notoriously difficult, and now the US Food and Drug Administration (FDA) is cracking down on companies fraudulently claiming that their dietary supplements can help treat, prevent or even cure the disease.
FDA on Monday released 12 warning letters and five advisory letters to foreign and domestic companies that are illegally selling more than 58 unapproved new drugs and/or misbranded drugs that claim to prevent, treat or cure Alzheimer’s disease and a number of other serious diseases and health conditions.
“Today’s actions are part of the FDA’s larger effort to address the booming growth of the dietary supplement industry through the implementation of modern regulatory initiatives that will enable the agency to preserve the balanced vision of the Dietary Supplement Health and Education Act (DSHEA), enacted by Congress 25 years ago,” FDA Commissioner Scott Gottlieb said.
Gottlieb also outlined several ways in which FDA is looking to move its regulation of dietary supplements forward, particularly as in the 25 years since Congress passed the Dietary Supplement Health and Education Act
(DSHEA), the law that enabled 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,” Gottlieb said.
As far as upcoming changes, FDA is exploring new ways to communicate more quickly when concerns arise that an ingredient is unlawful and potentially dangerous and should not be marketed in dietary supplements. He also noted how FDA is pushing toward the submission of new dietary ingredient (NDI) notifications so FDA
could evaluate the safety of a new ingredient before it becomes available
“We’re continuing to develop guidance for preparing NDI notifications to ensure FDA can thoroughly review the safety of these ingredients. In conjunction with this effort, we’re planning to update our compliance policy regarding NDIs,” he said.
The agency is also planning a public meeting this spring on the topic of responsible innovation in the dietary supplement industry, opening the possibility for a broader conversation on whether certain changes to the DSHEA might be helpful.
For example, some stakeholders have suggested that the statute should be amended to establish avenues for dietary supplement exclusivity and add a product listing requirement. A mandatory listing requirement could also provide significant benefits by improving transparency in the marketplace and promoting risk-based regulation, Gottlieb said.
The Council for Responsible Nutrition, a trade association for the dietary supplement and functional food industry, applauded the moves by Gottlieb and FDA, and called on Congressional appropriators to allocate to FDA the funding required to adequately police supplements and follow through on enforcement.