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Do FDA ‘guidance’ documents skirt the regulatory process?

The Food and Drug Administration’s penchant for “guidance” documents as opposed to formal rulemaking needs to end, according to a business-oriented public interest legal foundation.

“FDA’s turn away from notice-and-comment rulemaking has an obvious motive: Formal rulemaking can be quite cumbersome, and FDA would prefer where possible to avoid the time and expense involved,” says attorney Richard Samp. “But the agency’s embrace of informal rulemaking imposes significant and unwarranted regulatory burdens on affected businesses.”

Samp is chief counsel for the 40-year-old Washington Legal Foundation (WLF).

While WLF’s seven-page comment was in response to how FDA might improve regulations on drug evaluations, the agency frequently uses guidance documents to direct food safety efforts as well.

Samp says FDA’s “heavy reliance” on guidance documents as a regulatory tool undercuts the notice-and-comment rulemaking requirements of the federal Administrative Procedure Act (APA) of 1946 and imposes excessive burdens on regulated businesses.

The WLF comments suggest FDA should begin curtailing its use of both guidance and draft guidance documents. It points to two Executive Orders issued by President Donald J. Trump, directing agencies to reduce regulatory burdens on the public.

“There is no question that FDA guidance documents are encompassed with the review process mandated by the two executive orders,” WLF’s comments say. Both executive orders cover any “agency statement of general or particular applicability and future effect designed to implement, interpret, or prescribe law or policy.”

While FDA routinely states that guidance documents do not operate to bind FDA or the public, it also emphasizes that such documents embody FDA’s “current thinking” on regulatory issues. Also, agency enforcement personnel regularly point to guidance documents as their basis for concluding that a regulated entity is not complying with the federal Food, Drug, and Cosmetic Act.

In documenting FDA’s increasing reliance on guidance documents, WLF says the agency has released more than 2,000 guidance and draft guidance documents in recent decades. Many cover topics that were previously covered by formal regulations. The FDA has standard language that accompanies its guidance documents:

“This guidance represents the Food and Drug Administration’s (FDA or Agency) current thinking on this topic. It does not establish any rights for any person and does not bind FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance using the contact information on the title page.”

The Washington Legal Foundation says businesses cannot afford to ignore guidance and draft guidance documents from FDA, but it’s not possible to get courts to review them because of their informal nature.

Federal courts recognize the value of “notice and comment” requirements for public involvement, fairness, and creating a record for judicial review. FDA “in recent decades” has been “far less likely” to adhere to formal regulatory processes, according to the group.

It also calls for these reforms:

  • Draft guidance should automatically expire if not placed into final status within two years.
  • Any guidance that has been in effect for at least five years should be subjected to formal review to determine whether the subject matter of the guidance would more properly be incorporated into formal regulation.
  • No guidance will be issued in draft or final form until after FDA has made a formal determination that the use of APA notice-and-comment procedures is not feasible.

Among its involvements with the FDA regulatory processes, WLF has litigated FDA’s authority to restrict manufacturer speech, including the dissemination of medical texts and peer-reviewed journal where it said FDA’s attempted regulation was “particularly inept.”

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