FDA Decision to Suspend On-Site Inspections Shifts Safety Guarantees to Manufacturers

WASHINGTON, D.C. _ The law firm of Arnall Golden Gregory LLP (AGG) and the Natural Products Association (NPA) are providing industry insights on the impact of the Food and Drug Administration’s new move to suspend all routine plant inspections amid concerns over the rapid spread of the novel coronavirus, COVID-19.

The FDA explained its decision Wednesday as being essential to the safety of its own inspection teams, and in reaction to manufacturing plants prohibiting visitors in an effort to prevent spread of the virus. AGG and the NPA convened an urgent industry teleconference on Wednesday night, to raise questions about the agency’s decision:

1.  Does it put the safety of the nation’s food supply in peril?
2. Does it raise the specter of ‘bad actors’ taking advantage of new regulatory blind spots?
3. What should manufacturers do to protect themselves?

“The move clearly shifts the great responsibility of safety assurance back onto the manufacturers,” said Kevin Bell, a Washington D.C., partner at AGG, and a long-recognized nutritional industry legal and regulatory expert.

Bell urged all food and nutritional supplement industry companies to devise solid standard operating procedures, while acknowledging a new imperative to adapt as market and regulatory conditions will likely continue to change at a breakneck pace.

The FDA’s announcement that it was temporarily postponing routine inspections of facilities that produce food, medical devices, pharmaceuticals, cosmetics, veterinary products and other products came one week after it suspended foreign inspections.

Understanding a quick response is crucial, AGG and NPA organized the informational panel within hours of the FDA announcement. The interactive conversation lasted three hours as members of the industry sought immediate expert feedback from a panel with vast experience in crisis and food defense training.

“The first mindset for everyone should be we need to come up with best practices for now. And we need to be nimble enough that we can say next week we may be at a different standard,” Bell said.

Dr. Daniel Fabricant, president and CEO of NPA, the leading trade organization for the natural products industry, including organic and health foods and dietary supplements, said a critical way companies can protect themselves is to ensure they are training and communicating effectively with their employees now about COVID-19.

He also said certifiers will need to come to the table and adjust to new needs of the industry. “The whole Coronavirus issue goes to consumer confidence,” Fabricant said.

Attorney Robert Durkin recently joined AGG from the FDA, where he served as acting director of the Office of Dietary Supplement Programs. He stressed the need for all manufacturers to have a strong relationship with their local FDA officials, and to urgently and voluntarily alert them to any violations.

“The bottom feeders in the industry are going to try to take advantage of it,” Durkin said. “You really want to have a relationship with your local FDA and keep them in the loop when you hear of a problem.”

AGG Of Counsel Carolina Wirth, formerly regulatory counsel at the FDA, agreed with the need for vigilance and reporting of concerns.

“The FDA passed the buck,” she said. “There’s no way to know if bad actors are taking advantage of the situation.”

Durkin likewise urged manufacturers to “trust but confirm” their supply chain.

“Pull your supply chain as close as you can. Have a relationship with your partner and your supply chain, in sickness and in health,” he said.

ABOUT ARNALL GOLDEN GREGORY LLP 

Arnall Golden Gregory (AGG) is an Am Law 200 law firm with offices in Atlanta and Washington, DC. Our client-service model is rooted in taking a “business sensibility” approach of fully understanding how our clients’ legal matters fit into their overall business objectives.  We provide industry knowledge, attention to detail, transparency and value to help businesses and individuals achieve their definition of success. Our transaction, litigation and regulatory counselors serve clients in healthcare, real estate, litigation and other dispute resolution, business transactions, fintech, global commerce, economic development, public finance, government investigations and logistics and transportation. With our rich experience and know-how, we don’t ask “if,” we figure out “how.” Visit us at www.agg.com.