DSHEA at 25: Time for Celebration and Discussion

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The Dietary Supplement Health and Education Act (DSHEA) is officially 25 years old, and the industry is paying homage—and wondering about the future.

At a Glance: Then and Now…

1994 —> 2019
$4 billion industry —> $46 billion industry
42% of American adults use —> 77% of American adults use
 Trending: echinacea —> Trending: CBD          

The American Herbal Products Association (AHPA) released a statement of appreciation for DSHEA: “I hope you find a moment today to celebrate the 25th anniversary of the enactment of this momentous law,” said AHPA President Michael McGuffin. “The law has enabled the supplement industry to benefit from and contribute to an evolution in U.S. health by providing greater personal health care choices for consumers and promoting healthy lifestyle choices that increase consumer wellness.”

The Council for Responsible Nutrition (CRN), too, released a statement summarizing the debt the industry owes to DSHEA—and the importance of preserving its intent. “DSHEA’s anniversary week serves as an opportunity to recognize a quarter of a century of providing access to safe, quality products and health information to consumers, and regulatory certainty and incentives for improvement for the dietary supplement industry,” said Steve Mister, President and CEO. “DSHEA created the category of ‘dietary supplements,’ established the rights and requirements of businesses looking to enter the market, and secured access to a wide range of health products that consumers demanded.”

Present-day issues, however, require that we take a close look at DSHEA: “Today, consumer usage is at an all-time high and the product category continues to have a wide margin of safety,” Mister said. “As we celebrate the past, we must also think about the future and how we can improve the regulatory framework DSHEA created without disturbing the timeless balance of safety and access.”

At the Legal, Regulatory, and Compliance Forum on Dietary Supplements, Mister said that CBD could prove that DSHEA works—or could bring it down. Recently, though, he told WholeFoods that he was hopeful on the former: “DSHEA is ideally suited to deal with something like CBD. It requires a filed notification demonstrating that the product is reasonably expected to be safe. If FDA enforces this and other safeguards…it will create a regulated framework for CBD.”

Related: CRN on DSHEA at 25: The Industry is at a Crossroads
Dietary Supplements Regulatory Summit: Industry/FDA Unite; Discuss Future of DSHEA
FDA to Strengthen Regulation of Dietary Supplements in Collaboration with Industry

At SupplySide West, which featured a panel titled “DSHEA at 25: Legal Reform and the Future of the Law,” experts put forth their thoughts on DSHEA—and their concerns. “DSHEA in many ways has worked wonderfully,” Jim Emme, CEO of NOW Foods, told the crowd at the session. “It created an environment in which we can say we truly are regulated.” As for the future, Emme added: “25 years ago I said ‘Absolutely don’t touch DSHEA,’ but as the industry has grown, I’ve come to the conclusion that we do need to evolve and adapt to a more global environment and one where consumers are getting information from everywhere.” Emme explained his concerns: “One of the worst things that could happen is a consumer gets ill, but in the age of the internet and direct to consumer selling, there are these fast-and-loose companies and that’s a concern.”

McGuffin put forth the opinion that the Industry should hold off on any alterations until there’s actually a problem: “I like DSHEA 1.0,” he said, referring to 1994. “We’re now at DSHEA 1.1 because the law has been amended numerous times…I think in general in looking to see if we should seek to amend DSHEA or any law we should be asking whether any proposed change…will protect public health? Will it improve consumer access or [lead to] better information for consumers? Will it improve product quality? If we don’t have those criteria then we don’t need to act…we also should know that there is a problem that needs to be solved and that the law we enact would solve those problems. If we’re going to move we should meet those kinds of criteria before we propose any change to a law that’s working very well.”

Daniel Fabricant, Ph.D., President and CEO of the Natural Products Association, also noted that the Industry shouldn’t alter the law without plenty of forethought: “No one has a goal. What’s the goal? What’s going to happen in the next 25 years? What do we want that to look like?” Conversations need to focus on clear goals, he added, “and especially on what we need to do in and around the regulatory system, the legislative system, the judicial system—there’s not a lot of clarity and there’s not a lot of discussion.”

Using CBD as an example, Dr. Fabricant pointed to NPA’s recent poll, which found that 41% of Americans surveyed wrongly assumed FDA had already developed safety standards for CBD and 65% believe Congress should direct FDA to quickly set safety standards. “CBD is a promising new natural product,” he said in a press release, “but there is an acute risk of another major public health crisis if Congress allows these products to go unregulated or directs FDA to go easy on illegal products flooding the market. If CBD experiences a vaping-like crisis, it’s bad for public health, bad for the benefits CBD offers and bad for the hemp industry’s growth and job-creating potential.”

The message is clear: The Industry is what it is today thanks to DSHEA. As to the future of DSHEA and what the Industry will be tomorrow? WholeFoods will keep you updated.

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