Before we ring in the new year with a prospectus on the future of our industry, let’s recap the pivotal events of 2016 and what you did to support our trade association. NPA took a two-prong approach to Puerto Rico, which tried to impose a burdensome regulatory scheme on dietary supplements that amounted to nothing more than a money grab for the commonwealth. NPA’s grassroots in step 1 was necessary to gain attention from Congress to look at the Administrative Order 346. Step 2 involved NPA working with allies of the Congressional Task Force including Sen. Hatch and Rep Ryan Zinke and include it in the Task Force’s directives in the Puerto Rico Oversight, Management, and Economic Stability Act (PROMESA). As a result of NPA’s efforts, Puerto Rico’s Secretary of Health, Ana Ríus, placed a moratorium on AO 346. In local press (translated here), Ríus is on the record as stating that the only communication that she has had in this regard was in an email that she received on Friday from an advisor of U.S. Senate President Orrin Hatch, in which he asks to talk about this provision in PROMESA. She affirmed that prior to the enactment of the federal law, she did not know that this would be included. Chalk one up for allies on Capitol Hill and members of the Natural Products Association. Congratulations to Rep. Zinke for being selected as Interior Secretary.
The head-scratcher of the year had to be FDA’s use of an administrative proceeding to ban an ingredient that has been acknowledged without comment as an NDI five times over. It sent the message that you could file an NDI, receive a good-day letter from FDA, be lawfully marketed for 2 decades, and finally have FDA re-think it 20 years later, which by the way is the same time frame for establishing historical use. It also sets up a bad precedence that if left unchecked, the industry would feel the impact of a repeat. NPA engaged FDA to figure the cause for their concern. After understanding their issue, NPA wrapped up a nice Christmas gift in our comprehensive comments back to FDA to address how vinpocetine fits under 201(ff)(1) of the Federal Food, Drug, and Cosmetic Act. You can read them here if you need an escape from your relatives and immediate family. We think you will find a rather interesting argument that only former regulators could have developed.
The NDI re-draft was nothing new, but the reviews were mixed among the various trade groups. NPA wrote 98 pages of comments you can read here, so you know which way we were leaning with regard to the NDI guidance. NPA asked for a complete re-write overhaul. While guidance on this topic is critical to the industry, we need guidance that is reasonable and reflects the standard of safety set aside for dietary supplements in DSHEA. Unfortunately, the guidance sets up barriers to business by demanding food-additive levels of testing. The guidance treats botanicals different from synthetic copies of the other dietary ingredients, which is unreasonable, and it singles out probiotics. The guidance clearly points out the ingredient categories that are naughty and nice. FDA even failed to include self-affirmed GRAS as a pathway to market. NPA will be vigilant in how FDA exercises their enforcement discretion over the next year on NDIs.
To the surprise of many, FDA put a call out to industry to determine whether a definition for “natural” in human food is needed. NPA laid out a fair, reasonable approach to using the term “natural” or “all-natural/100% natural” in our comments here. NPA developed a tiered approach that parallels USDA’s Organic Standard. NPA will continue to advocate for one overarching definition of natural from FDA which would pre-empt any definitions which may be proposed by states.
NPA also beat back new changes to dietary supplement labels, applied from proposed conventional food labeling changes. When the proposed rule for Nutrition Facts Labeling (NFL) rolled out, NPA submitted a total of 3 comments to challenge FDA’s position. In particular, NPA challenged FDA’s lack of empirical data for insisting on changes to the Supplement Facts label. NPA astutely analyzed FDA’s submitted eye-tracking studies to point out errors, which actually supported our suppositions. You can re-read those comments here.
Finally, NPA also drafted comments to IOM on Women, Infants and Children (WIC) to expand the program to include dietary supplements. NPA attempted to expand HSA/FSA coverage to include dietary supplements. NPA drafted numerous comments on guidance and rules related to the Sunscreen Innovation Act. NPA enacted grass roots to deny a Massachusetts bill to restrict the sale of weight loss and muscle building supplements to minors as well as Richard Blumenthal’s defense authorization amendment to require third party certification for supplement sold on military bases.