In public comments submitted to FDA on July 15, 2019, the American Herbal Products Association made a number of suggestions to the agency, which has been in dialogue with the industry to modernize regulation of dietary supplements.
In public comments submitted to FDA on July 15, 2019, the American Herbal Products Association (AHPA; Silver Spring, MD) made a number of suggestions to the agency, which has been in dialogue with the industry to modernize regulation of dietary supplements. These comments are a follow-up to the recent public meeting held by FDA called, “Responsible Innovation in Dietary Supplements.”
Among the most pressing issue acknowledged by the agency and the dietary supplement industry is the enforcement of new dietary ingredient notifications (NDINs). Currently, FDA is on its second draft guidance for NDINs, but a number of topics in the proposed guidance remain contentious. For this reason, AHPA suggests that instead of issuing a third draft of the guidance, FDA should instead issue targeted guidance on key NDIN subjects. AHPA identified three priorities for FDA to issue targeted guidance: ingredient identification in an NDIN, clarification of the optional process of submitting a “master file,” and assisting NDIN submitters in describing broad conditions of use for the subject NDIs.
Evidently, a consistent flaw in NDINs is the lack of information on ingredient identity. Therefore, AHPA suggests that FDA issue a guidance on what information should be included in a NDIN to accurately identify the new dietary ingredient. “To the degree that responsible innovation for dietary supplements is dependent on the marketing of NDIs, and recognizing that incomplete descriptions of the identity of an NDI in a submitted NDIN is a hindrance to bringing NDIs to market, AHPA believes FDA can support responsible innovation in dietary supplements with no diminution of (and in fact, in furtherance of) FDA’s ability to efficiently and effectively protect the public from unsafe and unlawful products by providing good guidance on how best to identify an NDI within a submitted NDIN,” writes AHPA.
A “master file” is a concept supported by the industry, and originally introduced by FDA in its 2016 Revised Draft NDI Guidance, but there is a lack of clarity on what a “master file” would entail. The biggest concern for companies submitting NDINs is the protection of intellectual property. “AHPA encourages FDA to establish use of an NDI master file as one option that can help provide an efficient path to compliance for responsible companies and, significantly, also protect the intellectual property of those investing in costly safety studies and interpretive reports,” writes AHPA. “Importantly, FDA should make clear that all safety data submitted in an NDI master file, including unpublished studies, will be considered trade secret information pursuant to 21 C.F.R. § 20.61(a) and therefore remain undisclosed except as directed by the original NDIN submitter.”
In a targeted guidance for describing broad conditions of use, AHPA wants FDA to “provide specific recommendations for the manufacturers or distributors of an NDI to provide in their NDIN broad descriptions of all of the dietary supplements that will include or may include the NDI, so long as the information submitted provides the basis for the submitter’s conclusion that the dietary supplements containing the NDI will be reasonably expected to be safe.”
Another interesting suggestion brought forward by AHPA is for FDA to revise its dietary supplement claims guidance to harmonize with the Federal Trade Commission’s (FTC) rules on “traditional use” claims.
For example, FTC allows marketers to demonstrate a particular benefit by describing its historical and traditional uses “in such a way that consumers understand that the sole basis for the claim is a history of use of the product for a particular purpose.”
“More specifically, AHPA requests that the Agency identify criteria that would support a truthful and nonmisleading claim for a supplement based on traditional use through reliance on clear evidence of traditional use, as documented by contemporary and historical authoritative references, and recognition that such evidence is, in fact, competent and reliable,” writes AHPA.
AHPA also suggested in its comments that FDA revise its interpretation of the drug exclusion clause. The current interpretation of the clause prevents manufacturers to market an ingredient in food or dietary supplements when it is subject of investigational new drug application (IND). The most recent example of this would be CBD, which FDA says cannot be marketed in food or dietary supplements because it is the active in new drugs approved for the treatment of epilepsy. AHPA believes this disincentivizes dietary supplement innovation.
The current interpretation of the drug exclusion clause is particularly unfair when you consider that a company can develop and market a product in compliance with the FD&C Act, while the existence of an IND is maintained by FDA and the IND sponsor as confidential. Then, upon publication of the results of the previously confidential IND, FDA can assert that the manufacturer can no long market its product as a dietary supplement.
“Proper statutory construction and fairness demand that, for the drug exclusion rule to be triggered, all three elements noted above (effective IND, substantial clinical investigations, and publication of their existence) must occur and that the date by which a food or dietary supplement must be marketed to avoid this exclusion is the date on which the drug developer has satisfied all three conditions (and not merely the date on which the confidential IND took effect),” writes AHPA.
Finally, AHPA urges FDA to complete rulemaking to define the terms “natural” and “healthy.” FDA has already issued Federal Register notices on the term “natural” on November 12, 2015, and on the term “healthy” on September 28, 2016, and opened them up to public comment. Unfortunately, little progress has been made since that time.
“Almost certainly many dietary supplement ingredients, including for example herbs and simple herbal extracts, would meet definitions for ‘natural’ and for ‘healthy’ that are based on the plain meanings of those terms,” writes AHPA. “Defining these terms and establishing clear regulatory criteria that must be met to use these terms in dietary supplement labeling would support responsible innovation for products that are, in fact, natural and healthy, and may motivate supplement companies to produce and market dietary ingredients and supplements that meet such definitions.”