As we move past the early days of the Biden Administration and the 117th Congress, all signs suggest that we will move into the standard “gridlock” mode that we are all too familiar with from our experiences over the past decade. While the U.S. Food and Drug Administration (FDA) seems to finally be showing signs that it may finally be willing to use its powers over new dietary ingredients (NDIs) to block illegal imports at the border, the agency remains mired in the regulatory morass created by its refusal to even attempt to regulate cannabidiol (CBD). At the Federal Trade Commission (FTC), enforcement appears to remain squarely focused on products and services claiming the ability to prevent, treat or cure COVID-19. In short, the odds of any action that will have a significant impact on the dietary supplement industry coming out of Washington appear remote.
The lack of big news in Washington does not mean that the supplement industry can sit back and rest on the laurels of its past victories. All signs point to the acceleration of the trend that has seen action of concern shift to the state level. As noted by Dr. Daniel Fabricant, president and CEO of the Natural Products Association (NPA):
“Proposed legislation with dangerous and far-reaching implications seems to be bubbling up in more and more state capitals from Albany to Sacramento and we are on full alert for copycat legislation. Thanks to our extensive network of retailers, NPA members and other industry stakeholders, we have been able to block many of these initiatives from seeing the light of day. Just as we work at the state level to block efforts to reduce access to dietary supplements, we are using our interactions on the state level to redoubling our efforts to ask our allies to help expand access to nutritional supplements through federal programs and health savings accounts.”
State Legislation of Concern
While the idea of traveling to, or even having Zoom meetings with state representatives in Albany, NY, Springfield, MA or Sacramento, CA might not have the same sense of glamor and attraction as working with members of the United States Congress in Washington, a review of some of the proposals that have already been introduced in state houses shows why maintaining vigilance on this level is vitally important.
• New York
o AB 4919 Provides that no person shall manufacture, sell or expose for sale any product as a dietary supplement or nutritional supplement without branding or labeling such product with a statement that the product has or has not been tested by the FDA. This bill also calls for the Commissioner of Agriculture and Markets to promulgate rules and regulations defining the terms dietary supplement and nutritional supplement.
o SB 16 and AB 431 Relate to establishing restrictions on the sale of over-the-counter diet pills and dietary supplements for weight loss or muscle building; prohibits the sale of over-the-counter diet pills or dietary supplements for weight loss or muscle building to people under 18; increases the penalty amount for the sale or promotional distribution of dietary supplements containing ephedra. Bill Summary Prohibits the sale of over-the-counter diet pills or dietary supplements for weight loss or muscle building to people under 18. Increases the penalty amount for the sale or promotional distribution of dietary supplements containing ephedra. The bill would make a violation of these provisions by a retail establishment subject to a civil penalty of no more than $2,000.
• California
o AB 1341 Would prohibit a retail establishment from selling dietary supplements for weight loss and over-the-counter diet pills, as defined, to any person under 18 years of age. The bill would require a retail establishment, among other things, to limit access to those products, as specified, and would require the department to determine which products will be subject to those access limitations. The bill would also require the department to develop a health-related notice regarding those products and would require a retail establishment to conspicuously post that notice at each purchase counter. The bill would make a violation of these provisions by a retail establishment subject to a civil penalty of no more than $1,000 and subject to the Unfair Practices Act as an unfair practice.
• Massachusetts
o SD 678 and HD 1309 Prohibit the sale of dietary supplements for weight loss or muscle building to people under 18. This includes but is not limited to thermogens, liptropics, horomones and appetite suppressants. The bill would make a violation of these provisions by a retail establishment subject to a civil penalty of no more than $2,000
o HD 2476 Prohibits the sale of energy drinks to people under the age of 18 years old.
The emergence of these state proposals so early in the new legislative sessions is likely a portent of things to come, and signals an ongoing, misguided effort to scapegoat supplements, trade on persistent myth that they are unregulated and poses a threat to brand the category as dangerous. Moreover, as Fabricant observes, prohibition of popular consumer products almost never works. Prohibiting the sale of products by licensed retailers will only make consumers more vulnerable to fly-by-night outfits selling fake products and illegal drugs masquerading as supplements. Local health food stores have been declared essential by federal and state governments because they provide critical supplies that people need during the pandemic.
Moreover, many of these state proposals are focused on local retailers and do not apply to internet sales, further increasing the potential exposure of consumers to fly-by-night products.
As with issues on the federal level, active engagement can have a significant impact on state legislators, who are even more likely to take direct contact from constituents very seriously. Recent examples where a grass roots, direct action approach worked to block anti-supplement legislation in states houses ample demonstrate this point.
• South Carolina: H4198/H4352 would have prohibited the sale of soft drinks containing a minimum of 71 milligrams of caffeine per 12 fluid ounces and methylxanthines, B vitamins, guarana, ginseng, taurine, glucuronolactone or any extracts or variations of these ingredients to a person under the age of 18.
• Massachusetts: H1978 would have prohibited the sale of beverages with a caffeine content of 6 milligrams per one fluid ounce and containing taurine and glucuronolactone or a soft drink classified as a dietary supplement that contains 80 or more milligrams of caffeine per 8 fluid ounces to a person under the age of 18 years old.
• Illinois: HB3948 would have made it a violation to sell over-the-counter diet pills, including dietary supplements, to any person under the age of 18. The bill would also have restricted the manner in which these products could be displayed and access to these products in accordance with regulations that were to be promulgated by the state Department of Public Health.
The Need to Act
Of particular note, legislation proposed in California, New York and Massachusetts have provisions that would enact more severe penalties for not restricting access to nutritional supplements than if that same retailer sold a minor alcohol or tobacco. State legislators peddling proposals that restrict access to natural products, they are punishing the three in four Americans who use these products every day to maintain their health, which is questionable at best during a pandemic.
If the supplement industry is to continue its successful protection of health freedoms and consumer access to natural products, engagement by all stake holders will be necessary. The need to support trade associations such as the NPA cannot be understated, but there is also much that individuals and companies can do on their own. Most “local” government officials are eager to meet with constituents. You can make direct contact with your state senator or representative. Set a meeting at their local office or even invite them to tour your facility or to visit your store and meet with your employees. This will give you the opportunity to explain the health benefits of your products, as well as the financial impact your business contributes to their district and why it is in their benefit to support beneficial legislation and oppose negative legislation. You never know what a little contact may accomplish. NIE
Marc S. Ullman represents clients in matters relating to all aspects of U.S. Food and Drug Administration and Drug Enforcement Administration matters, regulatory issues, Federal Trade Commission proceedings and litigation. He practiced with one of New York’s leading white collar criminal defense firms for 10 years, where he represented clients in both federal and state prosecutions, as well as numerous related civil matters and other litigations. He can be reached at [email protected].
Kyle Turk is the director of government affairs for the Natural Products Association (NPA) and joined NPA in 2019. Prior to to that, he was working nationally to elect candidates to state-level office, including lieutenant governor, secretary of state and state legislators. Turk has extensive experience in politics and policy, previously working for Deputy Minority Leader Bob Singer in the New Jersey State Senate. At NPA, Turk works with members to advance identified legislative priorities, develop positions and communicate with NPA members on these positions. He also analyzes potential impacts of government action, both proactively and reactively to NPA members. For more information, visit www.npanational.org.
