Celebrating 30 years of DSHEA: Taking a look back to look forward

Its writing and passage were fueled by a mix of historical, cultural and political factors that created a unique climate for regulatory reform—from the rise of health-conscious consumerism and public distrust in government intervention to a powerful grassroots movement advocating for industry and health freedom. 

The law amended the Federal Food, Drug, and Cosmetic Act of 1938, creating a regulatory framework specific to dietary supplements. It emphasized consumer access and the industry’s ability to operate without undue regulation but within a set of provisions governing definitions, claims, safety, statements of nutritional support, labeling, new dietary ingredients and good manufacturing practices.

By categorizing dietary supplements as a subset of food rather than drugs, DSHEA ensured that they would not be subject to the same strict pre-market approval requirements as pharmaceuticals. Instead, it shifted the burden of safety and truthfulness in labeling to manufacturers, while the Food and Drug Administration (FDA) retained the authority to act against unsafe or misleading products but only after they had been brought to market.

Below a collection of articles offering a glimpse into DSHEA’s storied past and some of the considerations going forward.

A look back at the Proxmire Amendments: ‘There wouldn’t have been much of an industry’ ​: Before DSHEA and today’s booming dietary supplement market, there were the Proxmire Amendements. 

The role NPQAA played in the passage of DSHEA​: The short-lived Natural Products Quality Assurance Alliance played an important behind-the-scenes role in the passage of DSHEA, but what was it and how did it help sway Congressional support for DSHEA?

Fmali v Heckler: The landmark herb case that changed the industry​: It started with 10-speed bicycles and ended with an Appeals Court decision in 1983 that changed the herb industry and knocked FDA down a peg. 

A look back at the OTC botanical drug route ​: In 1992, Bill Clinton was elected president, Silence of the Lambs swept the Academy Awards, grunge broke into mainstream fashion, and the phrase “surfing the Internet” was coined. 

'A titan of the Senate': Supplements industry pays tribute to Sen. Orrin Hatch ​: The dietary supplements industry paid tribute to Sen. Orrin Hatch, who passed away on Saturday, April 23, 2022 in Salt Lake City, Utah at the age of 88.

DSHEA at 25: Revisiting our conversation with Scott Bass and Loren Israelsen​: From the brilliant strategy of Sen. Orrin Hatch to the upswell of grassroots consumer pressure and the ‘highly unusual’ personal intervention of an FDA Commissioner, the development and passage of the Dietary Supplement Health and Education Act is a fascinating story...

Dietary supplement industry remembers Bill Richardson​: Former New Mexico governor and congressman Bill Richardson, who died Sept. 1 at age 75, dedicated his life to public service and freeing political hostages, but he also championed the dietary supplement industry when it needed it most.

DSHEA at 30: ODSP director ticks through industry report card​: At the DSHEA Summit held in Salt Lake City this past June, Dr. Cara Welch, director of the Office of Dietary Supplement Programs (ODSP), had an allotted 10 minutes to provide a report card on the state of the industry.

'Uniting for a higher purpose': The story behind DSHEA​: Loren Israelsen, president of the United Natural Products Association and a key architect of DSHEA, discusses the beginnings of DSHEA and how fierce competitors came together for a common cause.

Considering clinically relevant herb-drug interactions 30 years on​: When DSHEA created the modern U.S. dietary supplement industry in 1994, it also conferred a new identity on botanicals and with it some considerations about potential phytochemical interactions.

USP advocates for regulatory reform in dietary supplement industry​: Since the passage of DSHEA, the dietary supplement industry has expanded from about 4,000 products to an estimated 80,000 today. With 80% of U.S. consumers using dietary supplements, some say a stronger regulatory framework is needed to address the growing and changing industry, including the United States Pharmacopeia (USP).

Sen. Durbin reintroduces Dietary Supplement Listing Act, industry reacts​: U.S. Senate Majority Whip Richard Durbin (D-IL) introduced the Dietary Supplement Listing Act of 2024, which would require dietary supplement manufacturers to list their products with the Food and Drug Administration (FDA).

The DSHEA Summit in pictures​: The DSHEA Summit, which took place on June 10, 2024, brought together the architects of the law and key industry stakeholders to discuss the past, present and future of the U.S. dietary supplements industry.