With DSHEA – the Dietary Supplement Health and Education Act – celebrating its 25th anniversary this year, there are a lot of conversations happening around the existing regulations and what may come next.
Just recently, FDA Commissioner Scott Gottlieb announced the inception of a public dialogue process this Spring to discuss possible changes to DSHEA, the launch of a Botanical Safety Consortium, and ways to reinvigorate the NDI process.
Speaking at length with NutraIngredients-USA, industry veteran Venardos said: “I think DSHEA has served consumers, the government, and the industry well for the past quarter century. Keep in mind it was passed unanimously by Congress and signed into law by President Clinton. FDA has been in a state of implementing the law for the past quarter century and it’s not quite fully implemented yet.
“There are areas where we in the industry would like to see FDA fully take advantage of their opportunity to create guidance such as the revised draft guidance on New Dietary Ingredients, and also to do a more robust job in signal detection when it comes to post market surveillance.”
“We know from our friends at FDA… that they don’t have the resources that they would like to do. You’re talking about 28 full-time equivalent positions for an industry that’s somewhere around $40 billion.
“I think there are things they could be doing in the area of enforcement to level the regulatory playing field,” said Venardos. “We know, for example, through our work at the Natural Products Association that there are companies that are violative. They are selling products containing drug analogues, they’re selling products masquerading as supplements making disease risk reduction claims, there are products being held in facilities that are not cGMP compliant. FDA currently doesn’t have the resources to address all of those at the same time.”
Transparency, accountability, and more
Venardos, who is currently vice president of regulatory and government affairs at bodybuilding.com, also shared some thoughts on how to better regulate dietary supplements in the interest of protecting consumer health, improving transparency, ensuring a level regulatory playing field, and FDA staff accountability.
Structural Re-Alignment & Enhanced Accountability
1. Separate the FDA Center for Food Safety & Applied Nutrition as well as the Office of Dietary Supplement Programs from the current FDA. Roll them into an enhanced United States Department of Agriculture & Nutrition.
2. Give FDA the authority to not only seize violative product but also assets of the offending parties. Seized assets could then be used to add FTEs to more vigorously enforce current regulations.
3. Within one year of seeking public comment on an issue, the Agency must render a final decision concerning the matter in question. A good example is vinpocetine.
4. The Director of the Office of Dietary Supplement Programs should be given the authority to sign Warning Letters.
The Office of Dietary Supplement Programs should be required to:
a. Post all 483s within one month of issuance (and updated as further information becomes available)
b. Post all NDIs (while not disclosing any business confidential information) and an indication as to the status of the NDI
c. On a quarterly basis, post redacted summaries of Serious Adverse Event reports and FDA ‘s assessment of the data to help stakeholders understand the potential for health risks given the Agency’s signal detection.
The Office of Dietary Supplement Programs should be required to increase its capacity to conduct a greater number of rigorous cGMP inspections of manufacturers and holding facilities.
Venardos on FDA Commissioner Scott Gottlieb
“I’ve had the chance to opportunity to be with and meet Commissioner Gottlieb in his prior work outside of FDA, and when he was at FDA during the Bush Administration. He is a fine, thoughtful, well-spoken professional.”