ACTION ALERT!!!!!
Memo Re: FDA’s Request for Comments on the Prohibition of Introduction into Interstate Commerce of Any Food to Which has Been Added a Drug or Biologic with Certain Exceptions
Date: December 7, 2008
Recently NHFA/NFHC received numerous emails requesting confirmation of accuracy of Action Alerts being drafted and circulated by a number of health freedom advocacy organizations about an FDA Request for Comments. We write this memo to let our supporters know that the Request for Comments is indeed important but the sky is not falling.
Many wonderful organizations and supplement companies have provided comments to the FDA to offer the FDA guidance as to the interpretation of the 2007 law passed amending the Federal Food, Drug, and Cosmetic Act. The law prohibits, with certain exceptions, interstate movement of foods to which drugs or biological products have been added. The wording causing concern is the prohibition of:
The introduction or delivery for introduction into interstate commerce of any food to which has been added a drug approved under section 505, a biological product licensed under section 351 of the Public Health Service Act, or a drug or a biological product for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public…”(Section 912 of FDAAA established a new section 301(ll) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 331(ll)).
The FDA request for comments was posted July 29, 2008 and the final deadline for comment was October 27, 2008. Some companies and organizations obtained an extension of the deadline and submitted their comments as late as November 25, 2008.
The main issue presented has to do with the potential of the FDA to interpret the new law in a way that would conflict with the protections spelled out in DSHEA (Dietary Supplement Health and Education Act of 1994) for dietary supplements and research being done on dietary supplements. Regarding implementing this new law, the FDA believes that they have the power of discretion to interpret the new law and they asked the public for feedback on what impact various interpretations would have on products and consumers. No formal rulemaking by FDA has been initiated.
Many companies and organizations have submitted comments to offer guidance to the FDA. NHFA recommends for a detailed understanding of the issues that you read the comments submitted to the FDA by the American Herbal Products Association (AHPA). (Link below) They have done an excellent and thorough job at providing guidance to the FDA on how the FDA should proceed, and what the understanding and the expectations for interpretation of the law advocates of DSHEA have. NHFA does not support the FDA deeming dietary supplements that are being investigated to be considered “drugs” just because they are being studied, and we expect the FDA to uphold the current definition of a dietary supplement and its clear protection that clinical research can be done on dietary supplements without them being considered drugs. We support AHPA’s comments that: “It is AHPA’s position that in order for a substance to be a “drug” that cannot be added to food under section 301(ll), the drug must be the same as a “drug” that is approved under Section 505 or that is the subject of substantial clinical investigations for drug-use endpoints that have been made public and which have been authorized under 21 CFR Part 312 for the diagnosis, cure, mitigation, treatment or prevention of disease. Absent any specific legislative instruction, the term “drug” must be assumed to have the same meaning in section 301(ll) as it has in every other part of the Act.”
Go to Regulations.Gov website. They have similar comments regarding biologics.
In addition we appreciate the vigilance that the National Health Federation provides about this Request for Comment, and we support the facts spelled out in the Press Release circulated by the National Health Federation and their statement: “Under the looser wording of Section 301(ll), the risk is that anyone – especially pharmaceutical companies or predatory supplement companies – could launch a clinical investigation on an ingredient, publish the data, and then they or the FDA could claim that the ingredient is no longer a dietary supplement but a drug. Or, even worse, the FDA could decide on its own that some dietary supplement such as Omega-3 oil, which has almost 5,000 published studies on its beneficial effects, fell within the "clinical investigation" ambit of Section 301(ll) and would henceforth be treated as a drug instead.” That is the essence of what the trade associations and many persons are concerned about. However, as the law firm of Ullman, Shapiro & Ullman has backed up with substantial legal research in its comments submitted to the FDA last month, the FDA has no authority to apply Section 301(ll) to dietary supp lements because Section 301(ll) neither amends nor overrules Section 201(ff)(3). Practically everyone else – including the NHF – joins in this assessment. http://www.thenhf.com/press_releases/pr_01_dec_2008.html
At this current point, NHFA is confident that the FDA will appreciate and listen to the guidance that has been provided to them by experts in the field and that they will honor the interpretations of existing law in the best light. However, as health freedom advocates we will be vigilant to this issue, and if the FDA waivers in their path of protection of DSHEA, we will cross that bridge if we come to it with a united strong voice and action.
Diane M. Miller J.D.
Director of Law and Public Policy
National Health Freedom Action
PMB 218, 2136 Ford Parkway
St. Paul, MN 55116-1863
Phone: 507-663-9018
Fax: 507-663-9013
Alt: 651-470-7367
