Activist FDA?

The Food and Drug Administration (FDA) has historically worked in a reactionary manner.  The original Pure Food and Drugs Act was passed by Congress on June 30, 1906 in response to studies that showed deleterious effects of food additives that were already in use in foods. Under Commissioner Scott Gottlieb, M.D., FDA has been busy taking on issues new and old that affect consumer products and in the process is showing signs of becoming an activist organization.

In September of this year the Commissioner announced a request for information on how consumers understand the use of dairy terms on plant based dairy substitutes.  This action comes twenty two years after the first market introduction of “soy milk”.  In the Federal Register Notice FDA invited “comments on the labeling of plant-based products with names that include the names of dairy foods such as “milk,” “cultured milk,” “yogurt,” and “cheese.” The agency plans to use the information gathered “to inform our development of an approach to the labeling of plant-based products that consumers may substitute for dairy foods.”

In recent months the agency has taken steps to curb use of nicotine vaping products by teens and children.  Electronic cigarettes entered the US market in the last decade.  At the time it seemed reasonable that the agency would have taken some action to regulate the devices but it did not. There are now laws and regulations in place that provide FDA with clear authority over the products and this month the FDA Commissioner asked the Center for Tobacco Products to revisit compliance dates for such products; presumably to call for earlier compliance with registration and listing as well as for removal of most flavored tobacco and vaping products.

While taking on an issue after 10 or 20 years is not an ‘activist’ move, in the past week FDA has issued warning letters to companies illegally selling the opioid drug tianeptine in products marked as dietary supplements. Commissioner Gottlieb’s statement about this clearly outlines his intentions for FDA to be more proactive than we have seen in the past:

“This action is part of a broader effort we have underway to re-examine our resources and authorities related to products marketed as dietary supplements, and outline a new policy on how we intend to more vigorously fulfill our obligations to protect consumers from dangerous products and unlawful claims.”

The dietary supplement industry is often labeled as ‘unregulated’ in the news media.  People in the supplement industry know that the sector is fully regulated but that FDA has created a bit of a monster by taking 10 years to publish GMPs, failing to finalize rules for New Dietary Ingredient Notifications,  and by being slow to take enforcement action against bad actors.  Dr. Gottlieb’s statement will be welcomed by many dietary supplement companies who often find their products disadvantaged in the marketplace when they are sold next to brands that do not comply with FDA regulations regarding permissible dietary supplement claims.

FDA under Scott Gottlieb is even showing signs of being proactive.  In October FDA and USDA jointly hosted a public meeting on production of cell-cultured food products derived from livestock and poultry cell lines.  After hearing from stakeholders the agencies have decided that they will jointly regulate these future products. This proactive approach should lead to clear naming and labeling regulations for these innovative products.

This month Dr. Gottlieb also made a statement regarding animal testing in drug development research aimed at reducing the use of dogs in such work.  He also announced guidelines on FDA’s recall authority and promised to continue work to swiftly alert the public and activate recalls.  I at least welcome this forward-looking approach to regulation and am optimistic that FDA’s initiatives to seek input from industry and other stakeholders will lead to regulations that allow for innovation and protect public health.

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