1. The New York Attorney General
Unless you lived in New York State, we doubt that many people in the dietary supplements industry would have heard of NY AG Eric Schneiderman 12 months ago. He burst into the collective consciousness of the industry on February 2, 2015 and has been influencing the conversation directly or indirectly ever since.
Say what you will about the approach or the technology employed, it’s clear that AG Schneiderman’s investigation into herbal supplements has pushed discussions about quality and transparency and how the products are regulated into the mainstream arena.
Our September 11 round-up of this investigation will walk you through all the major events of his probe, from those initial DNA tests to Devil’s Claw.
Click on the following link to hear Mark Blumenthal of ABC on how Schneiderman has pushed industry to ramp up quality game.
2. DNA testing
2015 was the year of DNA testing, which offers a lot of potential for botanical testing, and is incredibly reliable, but only when performed on appropriate material. However, botanical extracts are particularly problematic because, while some extracts may contain DNA, it may be of low quality or degraded to a point that makes it impossible to perform proper authentication.
The technology was gradually gaining acceptance in the industry where applicable, but the NY AG’s investigation has elevated its importance, and GNC’s agreement with the AG in March was seen as validation the use of DNA barcoding.
However, there is a potential dark side to this: For starters, DNA testing does not differentiate between plant parts – a leaf, twig, stalk, and root will all have the same plant DNA and give you a positive result. The technique also does not allow of quantification, leading some analytical experts to state that it has become the adulteration tool du jour.
3. Negative media
This is nothing new to the industry and there were plenty of negative articles and TV coverage in 2014 (remember John Oliver?) but it seems that the negative media around the industry journeyed to new levels this year. And there were plenty of stories to keep journalists busy: Results of the NY AG’s probe were heavily covered, particularly by the New York Times; we had coverage of the study into supplement use and ER visits; HBO ran a Real Sports segment on dietary supplement use in the US military and the deaths of several soldiers; the New York Times ran an article was questioning the benefits of omega-3s that was seen to damage the Always Omega-3 campaign; and on and on.
Interestingly, the majority of the mainstream media does now explain that supplements are regulated by DSHEA, even if they then go on to question the effectiveness of the regulations.
We picked this as one of the big trends of 2015, but the NY AG’s probe took the conversation to new places. AG Schneiderman himself called for greater transparency from the industry, while also refusing to make his testing data public (the irony of this should not be ignored, as this is an AG who once said, “Secrecy breeds corruption, while transparency generates confidence”).
The main trade associations have said that more transparency would be a good thing, both for industry standards and consumer confidence in the products. Discussions about product registries have been occurring both in public and private for many months, with the Council for Responsible Nutrition exploring the various options for a registry of products. Voluntary databases already exist, including the Office of Dietary Supplements’ Dietary Supplement Label Database (DSLD), the Natural Products Association’s TruLabel registration database, and UL’s ClearView program.
The industry is not united behind one particular database so we’ll follow how that develops in 2016.
5. FTC vs Bayer
The verdict was welcomed by all in the industry and sets an important legal precedent about what does and does not constitute ‘competent and reliable scientific evidence’.
Last year the US Federal Trade Commission brought a motion against Bayer for claims made in relation to Phillips’ Colon Health. The FTC case focused on two sets of claims – the expressed claims (structure-function claims for dietary supplements) and alleged implied claims. The FTC/DoJ alleged that Bayer violated a 2007 consent decree that prohibited the company making unsubstantiated claims for any dietary supplement it promotes or sells.
Writing in the court opinion (Case 2:07-cv-00001-JLL-JAD Document 196), US District Court Judge Jose Linares stated: “The Court concludes that the Government failed to establish, by clear and convincing evidence, that Bayer violated the 2007 Order issued by this Court.
“The United States did not carry its burden of proving that Bayer failed to possess and rely upon competent and reliable scientific evidence to substantiate its specific claims about PCH’s efficacy for constipation, diarrhea, and gas and bloating. Therefore, this Court declines to find that Bayer is in contempt of the 2007 Order.”
6. Senator McCaskill – The Guardian of the Cognitive Health Galaxy?
The Missouri Senator, who also serves as the ranking member of the US Senate Special Committee on Aging, is no stranger to dietary supplements – she led the Senate sub-committee grilling of Dr Oz in 2014 – but she has come into her won regarding brain health supplements.
Sen McCaskill opened an inquiry into brain health supplements this summer by sending letters to the FDA and 15 major retailers after launching an inquiry into products, regulations, and retailers in the dietary supplement industry that specifically market to seniors using claims about improving memory and treating dementia and Alzheimer’s disease.
This was followed by a letter to Stephen Ostroff, FDA Acting Administrator, calling for the Agency to suspend sales of supplements containing picamilon and vinpocetine pending an investigation, and then when the FDA didn’t act quickly enough for her, she wrote to 10 retailers asking their CEOs to “voluntarily remove any and all products containing picamilon that you may carry from your stores and from your website”.
Sen McCaskill’s focus so far has been on better enforcement of the existing regulations, and not on changing the regulations. Expect more from her in 2016.
7. Federal agencies crackdown
The Department of Justice, Federal Trade Commission, the Food and Drug Administration, the US Postal Inspection Service, the Internal Revenue Service, the Department of Defense. and the US Anti-Doping Agency announced a nationwide sweep targeting more than 100 makers and marketers of dietary supplements for alleged fraudulent ingredients and illegal claims.
The most high profile part of the announcement was the criminal case against controversial supplement company USPlabs LLC and several of its corporate officers.
Dietary supplement trade associations universally welcomed the crackdown, which was announced at a press conference on November 17.
The Natural Products Association issued a general statement, applauding the enforcement action against “rogue elements that are giving the overwhelming majority of legitimate dietary supplement manufacturers and retailers a bad image.
“This is good news both for millions of Americans who use dietary supplements and the hardworking people in our business who are meeting the growing demand for natural products.”
8. Division of Dietary Supplement Programs becoming an Office
This could be significant. It now looks like something of a formality that the FDA’s Division of Dietary Supplement Programs will be elevated to an ‘Office’. Speaking with NutraIngredients-USA at SupplySide West, Dr Cara Welch, Acting Deputy Director of the Division of Dietary Supplement Programs at the FDA, said: “We do believe that it would be good for the dietary supplement program to be elevated to an office. But there are certain processes that have to happen: it has to be signed off on by HSS, and then it has to go to Congress.”
Such an elevation would provide appropriate regulatory attention to the growing industry and increase FDA’s enforcement activities and priorities, said the main trade associations, which are all supporting this.
The probiotics sector continues to grow rapidly, with 20% growth reported by some sources. It continues to successful span dietary supplements, food and beverage applications, and the list of potential health benefits expands almost daily.
The International Probiotics Association underwent some significant changes to make it more agile and vocal in defending and promoting the friendly bugs. George Paraskevakos, formerly director of business development for probiotics supplier Lallemand, was appointed the new executive director, and there were big changes in Europe with the Global Alliance for Probiotics and the Yogurt and Live Fermented Milk Association joining forces with IPA to form a European chapter of the organization.
NutraIngredients-USA also hosted its first Probiota Americas event in San Diego in June and we’ll be back in 2016 when the event will be co-located with the IPA’s World Congress. That will be a must-attend event for every stakeholder in the sector.
10. GNC’s Annus horribilis
Last but by no means least: It’s been a tough year for GNC. The supplement giant was included in the first round of cease and desist letters from the NY AG, and then announced an agreement with AG Schneiderman that affirmed its Herbal Plus products meet FDA GMP requirements and thus validates their quality. The agreement was met with questions and criticism in the industry and Mike Archbold, CEO of GNC, then wrote an open letter to the industry explaining its position.
There were a couple of quarters of ‘disappointing’ financial results, and then the Oregon Attorney General hit them with a lawsuit against the company over supplements that include picamilon and BMPEA. The October 22 lawsuit alleged that these ingredients “do not meet the definition of a legal dietary ingredient and may not lawfully be used in dietary supplements.”
Share prices have fallen for GNC – shares were trading at $46.42 on January 2, 2015 (and they hit a high in August of $50.93) before the OR AG’s actions were announced, which sent prices plummeting. They now trade for $30.49 (December 15), a decline of 34% from the start of the year.
But it hasn’t been all negative for GNC with a new quality initiative for the supplement industry presented at the Dietary Supplement Analytical Summit put on by the United Natural Products Alliance in November. The GNC proposal received some support from the conference organizers
This is not our Spinal Tap moment (going to 11 on a scale of 10) but this is the one that possibly could have made the list had the revised draft guidance been published already. It was promised before the end of 2014 and now we’re almost at the end of 2015 and still no sign. There is still time for it to be released this year, or maybe we’ll have to wait until January…