Hamburg

Hamburg

The FDA has put supplement companies on notice that violators can expect earlier detection and prosecution. Remarks by commissioner Margaret Hamburg on Aug. 6 strongly suggest that the agency has shifted to a policy of less talk and more action. In a speech to the Food and Drug Law Institute, Hamburg said the FDA will be more vigilant, strategic, quick and visible.

To that end, Hamburg said the FDA has instituted six policy changes:

  • Fewer, if any warnings. “If we find that we must move quickly to address significant health concerns or egregious violations, we will consider immediate action – even before we have issued a formal warning letter,” Hamburg said.
  • Greater emphasis on swift enforcement. “When the public health is at risk, the FDA will reach out to our partners to take rapid action while we alert the public and prepare longer-term responses,” she said.
  • Fewer warning letters. The letters are now limited to significant legal issues. “Most enforcement letters will be able to move forward through a more streamlined process.,” Hamburg said.
  • Shorter post-inspection deadlines. “When the FDA finds that a firm is significantly out of compliance, we expect a prompt response,” she said. “The firm will generally have no more than fifteen working days in which to respond before the FDA moves ahead with a warning letter or enforcement action.”
  • More follow-up on enforcement actions. “After a warning letter is issued or a major product recall occurs, we will make it a priority to follow up promptly with appropriate action, such as an inspection or investigation to assess whether or not a company has made required changes in its practices,” Hamburg said.
  • Public notice of completed corrections. “We will provide to the firm a ‘close-out’ letter, indicating that the issues in the warning letter have been successfully addressed.”

In sum, a supplement maker can expect a knock on the door before getting a letter in the mail. If the FDA perceives a significant risk to public health, it will ask enforcement agencies to take immediate steps. In some circumstances, there will be no warning and no negotiation before a plant is shut down or a product is recalled.

Why is the change in policy needed? Hamburg, who has been on the job just 90 days,  pointed to slow action on serious violations regarding product quality; adulteration and misbranding; false, misleading, or otherwise unlawful labeling; and misleading advertising. Agencies took to long to respond because of procedures and policies, she said.

The industry response must be to get better or get out. Get better at controlling ingredient quality; get better at manufacturing; get better at documentation; get better at advertising and marketing; get better at legal representation. Otherwise, get out of the business.

While the actions may seem harsh, they increase the public’s confidence in the dietary supplement industry, Hamburg said.  “The solution is a commitment to compliance backed by a strong compliance program. Now is a good time to reassess whether you have such an effort in place.”

About 

Joel B. Rothman represents clients in intellectual property infringement litigation involving patents, trademarks, copyrights, trade secrets, defamation, trade libel, unfair competition, unfair and deceptive trade practices, and commercial matters. Joel’s litigation practice also includes significant focus on electronic discovery issues such as e-discovery management and motion practice relating to e-discovery.