But in several respects, it can best be characterized as "back-to-the-future."
The agency's warning-letter policy is of major importance to the grain, feed and grain processing industry, particularly since food/feed safety legislation being contemplated by Congress would give FDA broad new powers to require establishments to conduct hazard analyses, implement controls to prevent or reduce such hazards to acceptable levels, and implement written food/feed safety plans.
During an Aug. 6 speech to the Food and Drug Law Institute's annual meeting – you may read the text by clicking here – Dr. Hamburg said that the agency generally would begin issuing warning letters within 15 business days after notifying an offending facility that it was "significantly out of compliance." She said the new procedure is designed to rectify what she termed a "steep decline" in the agency's enforcement activity over "the past several years," in which some "serious violations have gone unaddressed for far too long." She said such violations include those involving product quality, adulteration and misbranding; false, misleading or otherwise unlawful labeling; and misleading advertising.
Hamburg also warned that FDA no longer will issue multiple warning letters to noncompliant firms before taking enforcement action. "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," she said. [Emphasis in original.] In addition, the FDA commissioner said the agency will "prioritize" follow-up to enforcement actions or product recalls by responding with a follow-up inspection or investigation to assess whether the offending establishment has made required changes to its practices. The agency also will "work more closely" with "regulatory partners," including state, local and international officials, to develop "effective risk- control and enforcement strategies," she said.
In a Federal Register notice issued Aug. 11, FDA further clarified the policy, which it said would take effect Sept. 15. Under the policy, FDA said it generally will issue warning letters 15 business days after the issuance of an FDA 483 Form that contains the inspection observations that constitute significant violations that may warrant enforcement action. That ostensibly has been the policy previously, with FDA's warning letters generally requiring establishments to provide a written response to the agency within 15 working days after receipt, with an explanation of steps being taken to correct violations and to prevent their recurrence. But what will change is that the agency generally no longer will delay issuing a warning letter while awaiting a tardy response from the targeted establishment.
Under the new policy, FDA states that if it receives from the affected establishment a response to the inspectional findings within 15 business days after the FDA 483 Form is issued, it will conduct a detailed review of the firm's response before determining whether to issue a warning letter. However, if the response from the affected establishment is received later than 15 business days after the FDA 483 Form is issued, a warning letter for serious violations likely will be issued, and the establishment's tardy response will be evaluated as part of the documentation received in direct response to the warning letter itself. FDA states that this procedure is designed to address past situations in which the issuance of warning letters – and the undertaking of potential enforcement action – has been deferred because of delays by establishments in responding to FDA 483 Form observations, as well as by multiple responses received from such establishments.
FDA did indicate in its Aug. 11 Federal Register notice that it plans to review this warning letter policy after 18 months to determine if it should be continued, with or without possible adjustments.
What's Changed: So, what's really changed?
In discussions with senior FDA officials this week, the NGFA has obtained the following information that puts the warning letter policy into better perspective:
- The major change is that the Obama administration is reversing a policy implemented by the Bush administration that generally required all warning letters to be reviewed and approved by FDA's Office of General Counsel before being issued. Only during its final year did the Bush administration begin allowing certain warning letters that were formatted under a pre-determined template to be issued without general counsel review.
The Obama administration is reversing this policy, such that generally, only those warning letters that involve substantive questions of law will be reviewed by FDA's general counsel's office in an effort to streamline what the new administration believes had become a backlog in reviewing warning letters prior to issuance. Top FDA officials told the NGFA that the kind of warning letters that still will be reviewed by the general counsel's office will be those involving alleged violations pertaining to advertising and labeling claims, as well as novel ingredients. But warning letters that involve alleged violations of current good manufacturing practice regulations (CGMPs) generally no longer will be reviewed by the FDA general counsel's office. This change reflects the policy that existed during the Clinton and previous Republican administrations, according to FDA. These officials projected that the biggest impact will be to expedite warning letters issued on human food and human drug products, not on animal feed or feed ingredients.
- The new policy concerning general counsel review of warning letters does not mean FDA district offices will have unbridled authority to issue such letters without appropriate review from FDA headquarters. FDA officials said that after meeting with Commissioner Hamburg, they envision management officials at FDA's various Centers – such as the Center for Veterinary Medicine (which regulates animal feed) and Center for Food Safety and Applied Nutrition (which regulates human food and raw agricultural commodities) – still being responsible for reviewing warning letters involving serious violations before they are issued. However, there were indications that if the alleged violations involve CGMPs where the law and science are "clear," district office directors will retain existing authority to issue warning letters.
- In Dr. Hamburg's speech, she stated that FDA would establish a new, formal warning letter "close-out" process in which the agency will post on its website information from a reinspection or other FDA determination that indicates an establishment has corrected violations cited in the warning letter and is in good standing as a way to motivate corrective actions. She stated that "not every type of warning letter will be eligible for a 'close-out' letter."
Key FDA officials said exceptions to the new "close-out" policy would be fairly rare, and cited such situations as an establishment or farm cited for violations of the BSE-prevention feed rule, but which subsequently has gone out of business since the warning letter was issued. Another example cited was a situation in which a correction made in response to warning letter cannot be validated (such as a biomedical monitoring device based upon an outdated research study).
- FDA officials did tell the NGFA that because the Obama administration is placing a greater emphasis on enforcement than the Bush administration, FDA district offices may be more inclined to pursue violations that they believe merit regulatory action than they had in the past, simply because they believed such alleged violations would not be pursued by FDA under the Bush administration.
The NGFA will continue to closely monitor FDA's implementation of its new warning-letter policy, and would appreciate being contacted by NGFA member companies that believe it is being implemented improperly. Contact Randy Gordon, NGFA vice president for communications and government relations at rgordon@ngfa.org, 202-289-0873, extension 12; or NGFA Director of Feed Services David Fairfield at dfairfield@ngfa.org, 712-243-4035.