AHPA urges FDA to break NDI issue into targeted guidances

AHPA filed its comments yesterday as part of the effort by the US Food and Drug Administration to gather input on how the regulation of dietary supplements might be improved.

The effort, dubbed ‘DSHEA 2.0’ as an industry insider shorthand, was inaugurated under former FDA Commissioner Dr Scott Gottlieb, MD. FDA held a meeting on the subject, under the formal title Responsible Innovation in Dietary Supplements, on May 16, at which time a public docket was opened for comments from industry and consumers.

AHPA’s comments focus on four areas:  revision of the New Dietary Ingredient Draft Guidance, a suggestion on regulation of ‘traditional use’ claims,  a framework for how the drug exclusion clause relating to Investigation New Drug applications could be altered, and a call for FDA to finally define the terms ‘natural’ and ‘healthy.’

Long, winding road on NDIs

The agency issued its first draft guidance on NDIs in 2011.  After significant pushback from and interaction with industry stakeholders and lawmakers (including former US Sen. Orrin Hatch, R-UT), FDA retrenched, and reissued the draft guidance 2016.  

That version also was a cause for concern within the industry, and has remained in draft form in the three years since it was issued.  FDA has repeatedly said that a proposed final form of the guidance would be issued ‘soon.’

Rather than wait for the whole guidance to be altered, and the probably inevitable give-and-take between the agency and the industry that will ensue, AHPA suggests the agency break down the process down into smaller chunks and issue targeted guidance on certain clauses of the draft guidance. 

It has often been observed by officials at FDA that the number of NDI Notifications over the years does not seem to reflect the number of new products on the market, which implies that many products are being sold with only sketchy regulatory underpinning. Quick agreement on all problematical points in the NDI draft guidance might be unlikely, but APHA said there is a need to make certain aspects of the system function better in the near term to incentivize compliance.

“[T]there is general agreement from all quarters that improvement is needed in the systems that have been established to implement these provisions,” ​AHPA said.

Four suggestions for targeted guidance

AHPA suggests the following targeted guidances should be issued:

• A guidance on how ingredients ought to be characterized. ​ AHPA notes that, “FDA has continued to observe lack of information on ingredient identity as a common flaw in NDINs.” ​ Giving more precise instructions on how ingredients should be described within a notification will make FDA’s job easier, AHPA noted.  The trade organization made a similar comment in response to the 2016 version of the draft guidance.
• Formalize the use of master files in NDINs. ​ The master file suggestion was contained in teh 2016 draft guidance; AHPA suggests that FDA further develop the idea so that companies could hold as trade secrets the precise specifications and manufacturing processes for their ingredients, and could grant the use of this information to other companies.
• Clarify the conditions of use provision. ​AHPA suggests a targeted guidance on this subject could help companies formulate the conditions of use portion of their NDI Notifications. 
• Step up enforcement of ‘knockoff’ NDIs. ​ As matters stand, companies that spend the time and money to file an NDIN risk having that effort go to benefit a competitor, who could bring a similar, but not necessarily identical, ingredient to market under the same regulatory umbrella.  This disincentives compliance, AHPA said.

Suggestions on claims, INDs and ‘natural’ definitions

On subjects beyond the NDI provisions, AHPA suggested that FDA work to harmonize its regulations with those of the Federal Trade Commission on how a company can market a dietary supplement with a ‘traditional use’ claim.

“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,”​ the organization wrote.

AHPA also suggested that FDA clarify exactly how an Investigation New Drug application on an ingredient can prevent that ingredient from being lawfully marketed as a dietary supplement.  INDs have a period in which they are confidential;  AHPA notes that a dietary supplement ingredient developer currently runs the risk of losing its investment if the existence of the IND is disclosed at some later date. 

Also, the trade organization suggested that FDA get around to defining the terms ‘natural’ and ‘healthy.’  AHPA said there are many herbal products that meet the definition of these terms as they are commonly understood.