NDIs – New Dietary Ingredients
The topic that gripped the industry for the second half of 2011 shows no signs of going away. The comment period on the Food and Drug Administration’s (FDA) NDI draft guidance closed on December 2, 2011, and now the FDA must wade through 146,000 pages of comments.
Will FDA go back to the drawing board on the NDI guidance? The draft guidance is the agency's current thinking on NDIs and to hit the reset button would mean a big shift in mind set.
Will we get a revised guidance – a compromise document – that captures the industry’s main comments? It depends on where the compromises must be made. Only time will tell. Expect NDIs to stay front and center for the industry.
And FDA has no deadline to respond to the comments, so this may drag on until…
The presidential election
Under President Obama the industry has experienced important developments: The Food Safety Modernization Act was introduced; ObamaCare struggled to its feet like a new born fawn while the wolves circled it, waiting for an opening to take it down; and of course FDA released the NDI draft guidance on President Obama’s watch.
November may seem like a long way away, but for the likes of Barrack Obama, Mitt Romney, Rick Santorum, Ron Paul et al., November is right at the forefront of their minds. The identity of the person sitting in the Oval Office obviously has significance for the industry – a new president may shake up FDA, appoint a new commissioner, and what would that do to the rest?
Trade associations
There will definitely be changes at the top of the Natural Products Association (NPA). The association announced just before the holidays that John Gay would leave his position as chief executive. Interestingly, no temporary replacement has been announced and the association will be steered by an interim leadership team.
NPA president Jeff Wrights said the process of finding a replacement had already begun and that he was confident of securing an “outstanding leader who can help us tackle the challenges we face as an industry and build on our success”.
Another change in the trade association landscape is the imminent arrival of the Dietary Supplement Manufacturers and Marketers Association (DSMMA). The DSMMA is said to be finalizing its by-laws and then an official announcement on the association’s founding will be made, along with a list of the founding members.
Adulteration
Consumers expect products that are safe and efficacious. Adulteration, and the economically motivated kind in particular, is a topic that will come to fore in 2012 more than ever.
We’ve already seen some bold and noble initiatives launched, like the collaboration between the American Botanical Council (ABC), the American Herbal Pharmacopoeia (AHP); and the University of Mississippi’s National Center for Natural Products Research (NCNPR) to tackle botanical adulteration.
Other groups and associations are also tackling this problem head-on and we can expect more in 2012.
GMPs
The NDI draft guidance may have dominated the headlines, but GMPs continue to be a vital issue for the industry, and FDA is enforcing them. FDA’s Daniel Fabricant, PhD, has already hinted at a tougher response to GMP violations, while Loren Israelsen from the United Natural Products Alliance (UNPA) told us recently that the GMP issue is a “topic of disappointment”.
“There is a general low level of GMP compliance,” Israelsen said. “This could be economic in terms of the cost to implement, or it could be that the threat versus reward ratio is not balanced.”
Either way, the issue cannot be ignored and companies need to ensure they are GMP compliant. We’ve already seen stiff prison sentences and million dollar fines related to GMP violations…
Watch those claims – everywhere…
2011 saw a visible increase in enforcement of claims by FDA and the Federal Trade Commission, and there were clear examples of the two working together. Label claims and claims being made on websites are under constant scrutiny, but companies should also watch what they say on social media platforms.
A warning letter from FDA to Nenningers Naturals, LLC from East Setauket, NY, at the end of last year referenced claims being made on the company’s Facebook and Twitter accounts.
The Olympics
Four years have passed since the last ones? Really? The world’s finest athletes will contest 26 sports in 39 disciplines at the 30th Olympiad in London, England. Pressures on athletes to perform are not easing and there will always be those who seek that little advantage in a pill or syringe.
Sadly for the industry, athletes often point to that supplement bottle on the shelf and plead ignorance of what it contains. Labels are clear, as is the list of banned substances. Could this be the year that the DMAA issue is put to bed? That’s what Travis Tygart, CEO of the US Anti-Doping Agency (USADA), is hoping.
The end of 2012 saw the first class actions brought against manufacturers of DMAA-containing products, and Tygart recently told us that he expected more class actions to come.
It will be incredibly satisfying if the games can pass with no fingers pointed at the industry. Indeed, many companies are getting certification that their products are safe for athletes. This week both GMP Labs and Wellness International Network obtained NSF Certified for Sport. Expect more to follow.
Delivery formats?
2011 was the year of the gummy – they were everywhere and adults seemed to love them just as much as the kids. So what next? We already previewed some of the up and coming delivery formats, from straws to beans, from strips to Blast Caps.
With all these new formats coming on the market it will be interesting to see how these blur the lines between food and dietary supplements, and what the regulatory folks make of all this.
There are clearly opportunities here, but there may also be regulatory pitfalls.