Speaking at last week’s Now, New, Next event in Phoenix, AZ, Mister, President and CEO of the Council for Responsible, told attendees: “We are already seeing this concept play out with TiO2. The EU has recently banned it. Not because there is any evidence that it is dangerous, but because there is not sufficient evidence that it is safe. The mantra is ‘When in doubt, just say no.’
“In Italy, where there has been a series of adverse events associated with turmeric, the precautionary principle has led to a withdrawal not just of the implicated products, but of health claims for all turmeric products.
“Make no mistake, the precautionary principle is not limited to TiO2; not limited to Europe; not limited to government bodies. It’s a mindset that is selectively applied whenever there is uncertainty. It removes all risk from society by starting with the premise that any risk is too much,” added Mister.
Consumer watchdogs in the US are also now looking at TiO2 and exploring ways to remove the ingredient from the market. And some plaintiffs’ attorneys have launched class actions against companies who use titanium dioxide “for their failure to warn based on those European actions”, he said.
The precautionary principle, which is the proposition that governments should err on the side of not accepting any risk for consumers, is also impacting efforts defend weight management products at the state level, said Mister. “When there is little or no perceived benefit, it’s easy to find supposed risks that justify restriction,” he said.
“So, we have negative portrayals of the industry as unregulated and potentially risky, one-sided coverage of the science without critical review, and a precautionary principle that argues any risk is too much (especially if there is no little or no benefit).
“This constellation of factors is a recipe for concern.”
MPL, prepare for other “would-be enforcers”, and more
In a wide-ranging speech at CRN’s annual conference, Mister also looked at a range of other issues affecting the industry, and what the response should be.
Mister said CRN advocates for new tools and resources, noting, “We can’t rely on the old ways of defending ourselves in this new environment.
“The solution goes beyond just demonstrating how we are already regulated to considering what new tools we can give our regulators that assure them our products don’t create unreasonable risk.”
Mister said the top of this list is Mandatory Product Listing (MPL), of which CRN has been a staunch proponent for several years. Language to establish an MPL had been attached to a bill reauthorizing FDA user fees for much of the summer, only for the dietary supplement provisions to be removed in the final bill that passed Congress recently.
“In an era where the narrative is working against us, it troubles me that opponents of mandatory listing will assert that FDA can adequately regulate an industry that it really can’t see. It just goes against any credibility we have accumulated,” he said.
“But let’s be clear: This is NOT a fundamental change in the balance of DSHEA – it’s a tool for enforcement. DSHEA is a law that was created when there were 4,000 products in the market, mostly sold in independent retailers versus a market today where there are more than 80,000 products today, sold online, direct to consumer, in retail, mass market, through medical professionals. The agency needs new tools just to keep up.”
Mister continued by noting that if FDA doesn’t project strength, there are no shortage of other would-be enforcers, with plaintiff lawyers keeping a close eye on the industry, while State legislative activity is also showing no signs of slowing down.
One key example was the recent attempt by lawmakers in California to pass a bill (AB-1341) that would have restricted the sale by retailers of certain dietary supplements for weight loss without a prescription or ID to those under 18. Included in the bill was a framework where the California Dept. of Public Health (CDPH) would have to evaluate each product based on express claims of weight loss on the label and whether the ingredients contribute to one of eight negative health conditions.
The bill was first introduced in the first quarter of 2021, and dietary supplement trade associations lodged their opposition. However, amendments introduced during the summer to narrow the scope and blunt some of the impact led to some associations to remove their opposition to the bill and adopt a neutral position, notably CRN and the American Herbal Products Association (AHPA).
Governor Newsom announced late September that he would not sign the bill into law, stating that the work required by CDPH to establish a list of dietary supplements that would be subject to the bill is beyond the scope of the department's capabilities.
“We dodged a bullet this year, but the issue will return next year,” said Mister.
Major retail chains are also taking matters into their own hands, said Mister, with their own programs using private third-party auditors to get assurance that GMPs are being observed.
Mister also said that self-regulation is vital. Over the past year, the association has published voluntary best practices for proprietary blends and a considerations document for dosage forms, he said.
Uncertain times
Mister concluded his talk by stressing that the industry today is not the same as the industry of 1994. “We need to accept that we are no longer a few former natural products enthusiasts who will forgive the occasional manufacturing error or overlook illegal ingredients or misleading claims.
“Today we are soccer moms, retirees, millennials, weekend warriors, professional athletes, pregnant mothers, but one of the fastest growing categories right now is children’s supplements. We are a $56 billion industry and that calls for being responsible in ways that weren’t required 28 years ago.
“It calls for not just exercising responsibility in times of uncertainty,” he said.
EDITOR'S NOTE: This article has been amended to clarify the chronology and details around California Bill AB-1341. We apologize for the initial ambiguity.