New York, NY—On June 27-28, the American Conference Institute (ACI) in collaboration with the Council for Responsible Nutrition (CRN) hosted the fourth annual “Legal, Regulatory and Compliance Forum on Dietary Supplements.”
The forum, which addressed new class action threats, enforcement activities by the state and federal government, state GMO laws, Prop 65 reforms and more was co-chaired by Scott Bass, partner and head of Global Life Sciences at Sidney Austin LLP and Steve Mister, president and CEO of CRN, who not only gave an overview of each topic, but also predicted agendas for the new Office of Dietary Supplement Programs (ODSPs).
Mister’s “Dietary Supplements: The State of the Union” began with a summary of last year’s actions by NY Attorney General Eric Schneiderman, who sent cease and desist letters to four retailers and rallied AGs to investigate the industry after DNA barcoding results of herbal supplements suggested retailers were selling fraudulent and potentially dangerous supplements. Though the attention brought negative press, Mister believes the situation has also had some positives. “I think the industry is now very engaged in looking at quality, at transparency, and at accountability. We see a number of industry-led initiatives going on, and you have both manufacturers and retailers focused on improving the reputation of the industry, not just in superficial ways, but actually doing things that will change the way people look at the industry.”
Mister also discussed several issues that the Industry is currently facing. The first was Senators Richard Blumenthal (D-CT)’s and Dick Durbin (D-IL)’s National Defense Authorization Act, which would have “required dietary supplements sold on military bases to have a third party certification as determined by FDA without giving any standards for what that would be.” While the bill was never voted on, Mister stated that the act of “demonstrating the political pressure of the industry to rally when something happens” was the most significant outcome.
The Dietary Supplement Labeling Act of 2014 was also referenced. Although the bill has not been introduced since 2014, Mister speculates that if introduced again, the bill could include:
- A mandatory product registration
- A mandatory label database
- Labeling warnings for “possible adverse effects”
- Pre-Market submission of claim substantiation
What the Industry Should Watch Out for
Mister noted that industry members should be concerned with Senator Claire McCaskill (D-MO), who is the ranking member of the Senate Aging Committee. While the Senate Aging Committee has no authority to determine which bills make it to the floor, Mister stated that McCaskill has a podium on which to garner enough publicity that can cause trouble for the industry. Recently, McCaskill wrote letters to retailers urging them to stop selling picamillion, a substance that does not meet the statutory definition of a dietary ingredient, and also wrote to healthcare professionals and associates that represent healthcare professionals asking them about supplements interactions with cancer medications.
The question of what would happen to the industry under the Safe Food Act of 2015 was also raised. Under the act, the FDA and USDA would reorganize and be placed under a single agency. The biggest concern is whether supplements would be placed under a food or a drug agency.
What the Agency Is Working on Now
With all of the current challenges the industry is facing, Mister was also able to point out a few potentially positive aspects, one being the ability to alter the Flex Spending Account (FSA) and Health Savings Account (HSA) rules to allow consumers to set aside pre-tax money to reimburse their qualified medical expenses.
There was also talk of seeking the inclusions of multivitamins and possibly other supplements, with FDA-approved health claims, for recipients receiving WIC and SNAP benefits.
Another positive is a study commissioned by CRN titled “Economic Impact of the Industry.” The study, which is available on CRN’s website, examines the effect the industry has on the economy and local community. The study also focuses on how the industry contributes to jobs and wages and what will happen to the economy if the industry were to shut down.
Regulations and FDA
With almost 500 GMP inspections in 2015, industry is urging FDA to take those who fail inspection repeatedly more seriously. Regarding FDA’s “sluggish response to steroids, synthetic stimulants and caffeine,” Mister believes the industry needs to see more prosecution in order for companies to be deterred.
Regulation and the FTC:
Recent cases and investigations that have made a substantial impact on the industry were:
- POM Wonderful: The court ruled the agency cannot impose a requirement of two randomized controlled trails to prove claims.
- Basic Research: the court ruled the agency had overreached by redefining “competent and reliable scientific evidence” by requiring RCTs and refusing to consider other kinds of data.
- Hi-Tech Pharmaceuticals: The court ruled against the agency for only allowing two RCTs and not allowing other evidence, such as evidence from an expert.
- Bayer/Phillips Colon Health: The court ruled Bayer did not violate the “competent and reliable scientific evidence” and ruled against the agency for holding Bayer to two RCTs for advertising claims.
State legislative activity is also heating up in Illinois, Ohio and New York with restrictions being placed on pure powdered caffeine. New York is also attempting to restrict sexual enhancement products, though the bill has not moved at this point. A new nutritionist licensing bill is also being sought, which would require nutritionists to become a registered dietitian in order to give advice on diet, improvement of health and overall nutrition.
What Does It All Mean for the Industry?
With all of the new scrutiny and unwanted press attention, Mister states that this may be “a tumultuous time for the dietary supplement industry and multiple challenges will be ahead.” Mister believes the best way to handle this is with “carefully monitoring, proactive initiatives and quick-trigger responses.”
Posted on WholeFoods Magazine Online, 8/15/2016