Essential Formulas Incorporated (EFI) and the newly formed Dietary Supplements Manufacturers and Marketers Association (DSMMA) filed comments prepared by The Venable Law Firm with the U.S. Food and Drug Administration (FDA) last week to withdraw the agency’s New Dietary Ingredient (NDI) Notification Draft Guidance, stating “It is our belief that the Guidelines exceed the authority provided by law. Further, the Guidelines should have been issued, if issued at all, as a "rule" applicable to the FDA's rule-making authority.”
According to EFI President and CEO Michael Schoor, “ The FDA’s Draft Guidance must be more narrowly tailored to accomplish the agency’s primary mission to protect and promote the health of U.S. citizens, without causing unwarranted injury to legitimate businesses and without denying consumers access to products that are important to their health and well being.”
EFI, DSMMA and an extensive list of others objecting to the Guidelines suggest that the Draft Guidance is unlawful in numerous respects and changes in interpretation and policy require notice and comment rulemaking. Because the terms of the Draft Guidance are at such tension with the statute, it is especially inappropriate to avoid the administrative due process requirements of rulemaking including judicial review. The Draft Guidance’s standards are significant changes to prior FDA regulatory standards (e.g., the exclusion of certain synthetic ingredients and probiotics from the definition of dietary ingredient). As such, FDA must follow its long-established rulemaking procedures to make such changes.
In addition, other specific areas of concern about the draft guidance include:
· the proposed definition of ‘dietary supplement’ cannot be squared with the statute;
· the Proposed Standards for ‘old’ dietary ingredients are unreasonable and unlawful;
· the requirement to submit product-specific notifications is unreasonable and contrary to congressional intent;
· the FDA’s transformation of NDI notifications in food additive petitions is contrary to the statute;
· the FDA fails to address the impact on small businesses.
“We urge the FDA to reconsider positions articulated in the Draft Guidance that are contrary to the statute and Congressional intent, contrary to science and to reasoned policy considerations and fully analyze the impact on small businesses of compliance with the NDI notification submission requirements under the Draft Guidance,” stressed Mr. Schoor.