We predicted that the NDI issue would drag on, and we were not wrong…
Top of the pile in January of issues to watch was the controversial new dietary ingredient (NDI) draft guidance. (To read our full list of predictions, please click here.)
Tempers seem to have cooled on this, although topics like synthetic versions of botanical compounds remain a tempestuous issue. When we talked to the FDA’s Dr Dan Fabricant recently, he admitted that talks are on-going with the trade associations, but there is currently no timeline on a final guidance.
The presidential election
November’s big day came and went, and nothing really changed. Steve Mister from the Council for Responsible Nutrition (CRN) recently told us that the results of the elections means, “we’ll continue to have four more years of divided government”.
“We’ll continue a lot of emphasis on regulation, and that was the first four years of the Obama administration. I think we’ll continue to see that and I don’t think we’ll see a dramatic ramping up.”
The dietary supplements industry was quite vocal about its support for the other guy, but maintaining the status quo in the White House means there is more stability at FDA…
We predicted more to come out on the topic of adulteration in the dietary supplements industry, and we haven’t been disappointed.
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) has continued to publish articles about the issue, and ABC’s Mark Blumenthal told us recently that black cohosh and pomegranate extracts are the next two topics in the series.
Other papers in the series, all published in HerbalGram, included grapefruit seed extracts (HerbalGram, 2012, 94:62-66), bilberry (HerbalGram, 2012, 96:64-73), skullcap (HerbalGram, 2012, 93:34-41), and a historical overview of the adulteration dilemma (HerbalGram, 2011, 92:42-57).
GMPs and industry compliance has dominated headlines in 2012. Elan Sudberg, CEO of Alkemists Laboratories, has said that current GMP compliance levels are ‘all over the place’, but ‘for the most part there is an increase in compliance’.
FDA’s Dr Fabricant has been equally vocal about how the Agency views industry compliance, and quotes by him in the Chicago Tribune angered many within the industry.
In an interview with NutraIngredients-USA at SupplySide West, Dr Fabricant stood by his comments, and noted: “There is not a clear indication there will be a drop in non-compliance anytime soon, and that concerns us.”
In addition to warning letters for GMP compliance violations, claims on product labels, websites and social media platforms have been under intense scrutiny by the regulatory agencies. FDA has not held back in sending warning letters for claims that have strayed too far into the realm of drug or disease claims.
What a success! The games recorded only eight drug violations – only one of which was linked to a dietary supplement – compared to 19 in the 2008 Beijing Games and 26 in Athens in 2004.
Trond Husø from the Anti-Doping Database (http://dopinglist.com/) told us there were a further 15 athletes selected for their national teams who tested positive in the immediate lead-up to the games, bringing the total to 23.
At the Olympics more than 5000 tests were performed in the GlaxoSmithKline-sponsored testing unit run by King’s College specialists under IOC jurisdiction. That meant about 1-in-2 athletes including every medal winner would be tested for more than 240 prohibited substances.
We also wondered in January if this would be the year that the DMAA issue would be put to bed. In April, the FDA issues warning letters against a number of companies alleging that the DMAA in their products is synthetic and not allowed for use in dietary supplements. We then had a couple more studies that failed to find DMAA in geranium, including one study described by many industry observers as the ‘final nail in the DMAA coffin’.
Like a zombie movie, some companies are refusing to accept that DMAA’s time may be up, with USPLabs leading the fight back with studies of its own that claim to prove the existence of DMAA in plant material.
So what will follow DMAA? We’ve seen the re-emergence of synephrine (bitter orange) and the arrival of supplements containing compounds like dendrobium (orchid). A class action from California alleged that the leading dendrobium supplement in this sector – Craze – contained amphetamines. The company behind the supplement – New York-based Driven Sports, Inc. – has defended the ingredient, and the product continues to perform well in retail outlets.
Expect the FDA to continue to keep a very close eye on the pre-workout category in 2013, and we’ll talk more about this in our 2013 predictions article in January.