Lawyers credit FDA dietary supplements office for improved communications

Lawyers credit FDA dietary supplements office for improved communications

January 1, 0001, Natural Products Insider

Natural Products Insider included Miriam Guggenheim’s remarks from a recent event hosted by the Council for Responsible Nutrition. . Ms. Guggenheim, who served on a panel about areas in which the Office of Dietary Supplement Programs (ODSP) is faring well since its creation in December 2015, Ms. Guggenheim suggested the relationship has improved between ODSP leadership and the industry. “There’s more of a respect for industry and starting position that industry really is out to do the right thing. They are not looking to cut corners, and that with appropriate guidance and clear and consistent guidance from FDA, industry players really are desirous of doing the right thing.”

Ms. Guggenheim said there are ways in which ODSP is providing incentives for “bad players” and disincentives for “good players” through “erratic enforcement and lack of clear guidance, so you don’t have the folks who would do things right even getting into the fray. They’re sitting on the sidelines while the less scrupulous players are jumping in and not necessarily crossing every ‘T’ and dotting every ‘I,” she added.

Ms. Guggenheim proceeded to cite  the CBD market as an  example. “The CBD context is exactly where you see the folks who would be the responsible players, who would apply the most rigorous GMPs [good manufacturing practices] and identity evaluations for the material … sitting back and waiting for clarity,” she said. FDA’s inaction, she added, means “only those who are willing to take a risk are entering the space, and that shouldn’t be the way the agency incentivizes the industry.”