Six Key Takeaways on Dietary Supplement Regulation, 30 Years Post-DSHEA | JD Supra (2024)

Six Key Takeaways on Dietary Supplement Regulation, 30 Years Post-DSHEA | JD Supra (1)

How advertisers, consumers, influencers, and others are changing the industry

Dietary supplement industry leaders and regulators gathered in Salt Lake City in June to examine the current status of the Dietary Supplement Health and Education Act of 1994 (DSHEA), 30 years after that legal building block became law. For those who may be new to this area, DSHEA is the law that defined "dietary supplements" as a subset of "food" under the federal Food Drug and Cosmetic Act. DSHEA also created categories of dietary ingredients, i.e., "old" and "new," and authorized the Food and Drug Administration (FDA) to regulate dietary supplements, in part by establishing good manufacturing practices, codified in 21 C.F.R. §§ 111, et seq. Simply put, the reason that we have a product category called "dietary supplement" is because of the framework established by DSHEA and FDA's implementing regulations.

Panelists expressed gratitude for how well DSHEA has operated to support the industry but also expressed concern about whether the law needs to be updated to keep pace with consumer demands, technology, and the differences in advertising today versus three decades ago.

Here are six key takeaways:

  • Consumers are more informed. By laying the groundwork for the dietary supplement industry, DSHEA also created a pathway for broader advertising and more informed consumers. As one speaker noted, "no one knew what gingko was in 1994" and now it's easily found at every mass retailer and online.
  • Changes in advertising add to the compliance challenges. Influencer marketing and self-care messaging have been powerful tools in reaching consumers over social media platforms that were not even contemplated when DSHEA was passed, creating an entirely "different marketplace with new, innovative ingredients, claims, marketing tactics, and an environment that evolves in days, not years," to quote one speaker. Many panelists expressed concern about the difficulty in managing the limitations on claims, both from a substantiation and structure-function compliance standpoint. Panelists also expressed concern that the FDA and the Federal Trade Commission (FTC) have been resistant to allowing industry to feature claims that address clinical research and innovation because of existing structure-function limitations and the FTC's evolving standards for "competent and reliable scientific evidence."
  • There is no consensus on how to improve enforcement. Panelists discussed the perceived lack of enforcement by the FDA and FTC on "bad actors" but did not agree on whether the solution would be to clarify or increase regulatory jurisdiction, increase involvement by other enforcers such as state attorneys general, or implement a broader self-regulatory program. As many readers may know, the National Advertising Division (NAD), an advertising self-regulatory body, regularly considers dietary supplement cases and provides multiple avenues for companies seeking to help ensure a compliant marketplace.
  • Contract manufacturers may get more scrutiny. Focusing on product compliance, Dr. Cara Welch, FDA's director of the Office of Dietary Supplement Programs, noted that her office believes inspection and scrutiny of contract manufacturers' compliance is an efficient investment because contract manufacturers regularly produce products for several brands. The agency's challenge, Welch noted, is that FDA does not currently have pre-inspection transparency into which contract manufacturers produce which products. A mandatory product listing is one way to achieve such transparency, but …
  • Mandatory product listing (MPL) isn't universally favored or opposed. Building on the potential for contract manufacturers as an avenue for evaluating compliance across brands, the potential use of MPL to achieve such transparency was met with mixed reaction. Welch favored it as a means of more easily identifying the party ultimately responsible for a product and giving the agency a full view of the market. Others noted that MPL would also drive public trust.

    Industry representatives countered that MPL details must be considered, including whether failing to submit materials to the MPL registry would render a product misbranded or ineligible for import or export. Industry also noted the need for a single regulator to help address recent state legislative efforts to restrict sales of certain products to persons under age 18, suggesting that to get industry on board with MPL, express preemption of state sale and labeling laws must be up for discussion. In short, if industry is going to broadly agree to submit to MPL, then there must be greater legal benefit and protection in it for them.

  • Would DSHEA be possible today? DSHEA was built on legislative compromise. Multiple speakers expressed concern that this kind of compromise probably isn't likely in today's highly partisan political climate and because industry champions from the past are no longer in office.

Despite varying opinions on how best to tackle these challenges, there was optimism that Congress may be open to creating a new framework for functional foods, which would broaden allowable claims, and accept that their risk profile is greater than that of conventional foods or supplements. This optimism was based largely on FDA's position that there is no current pathway for cannabidiol (CBD) and that a new structure is necessary. A new program specific to CBD would be economically inefficient, but if a new program included other functional products, it could bode well for the future of the industry.

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Six Key Takeaways on Dietary Supplement Regulation, 30 Years Post-DSHEA | JD Supra (2024)


What is one of the key parts of the DSHEA law? ›

The Dietary Supplement Health and Education Act (DSHEA) requires that a manufacturer or distributor notify FDA in advance and submit safety information if it intends to market a dietary supplement in the United States that contains a "new dietary ingredient," unless the new dietary ingredient is present in the food ...

What are dietary supplements according to DSHEA? ›

The term, dietary supplement, was defined by the Dietary Supplement Health and Education Act (DSHEA) as a product (other than tobacco) that is intended to supplement the diet which bears or contains one or more of the following dietary ingredients: a) a vitamin, b) a mineral, c) an herb or other botanical, d) an amino ...

How did the DSHEA Act change the dietary supplement industry? ›

DSHEA specifically reaffirmed the status of dietary supplements as a category of food and created a specific definition for dietary supplements. DSHEA made it clear that ingredients of dietary supplements could not be regulated as food additives.

What is the importance of DSHEA? ›

Data structures and algorithms (DSA) are the essential building blocks of coding. Understanding data structures' importance can help you better grasp how your code operates and how your computer handles the enormous amount of incoming data.

What are the problems with DSHEA? ›

The primary problem with DSHEA is that it severely limits the FDA's ability to ban unsafe dietary supplements because it forces the FDA to regulate dietary supplements reactively instead of proactively.

What is the DSHEA statement? ›

Under the Dietary Supplements Health and Education Act (DSHEA), the manufacturer of a dietary supplement or dietary ingredient is responsible for ensuring that the product is safe before marketing.

What are some safety considerations concerning dietary supplements? ›

Safety and Risk

Some supplements can increase the risk of bleeding or, if taken before surgery, can change your response to anesthesia. Supplements can also interact with some medicines in ways that might cause problems.

Which of the following types of claims was first established under DSHEA? ›

The Dietary Supplement Health and Education Act of 1994 (DSHEA) established some special regulatory requirements and procedures for structure/function claims and two related types of dietary supplement labeling claims, claims of general well-being and claims related to a nutrient deficiency disease.

What are the requirements for DSHEA labeling? ›

Five statements are required: 1) the statement of identity (name of the dietary supplement), 2) the net quantity of contents statement (amount of the dietary supplement), 3) the nutrition labeling, 4) the ingredient list, and 5) the name and place of business of the manufacturer, packer, or distributor.

Which of the following is a primary goal of DSHEA? ›

Abstract. The Dietary Supplement Health and Education Act (DSHEA), enacted in 1994, had two primary goals: to ensure continued consumer access to a wide variety of dietary supplements, and to provide consumers with more information about the intended use of dietary supplements.

What is the DSHEA Act of 1994? ›

Dietary Supplement Health and Education Act of 1994 - Amends the Federal Food, Drug, and Cosmetic Act to define a "dietary supplement" as a product: (1) other than tobacco, intended to supplement the diet that contains a vitamin, mineral, herb or botanical, dietary substance, or a concentrate, metabolite, constituent, ...

What is the history of DSHEA? ›

The Dietary Supplement Health and Education Act of 1994 ("DSHEA"), is a 1994 statute of United States Federal legislation which defines and regulates dietary supplements. Under the act, supplements are regulated by the FDA for Good Manufacturing Practices under 21 CFR Part 111.

Does DSHEA regulate the safety of dietary supplements? ›

Under the Dietary Supplement Health and Education Act of 1994 (DSHEA): Manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded.

What is the purpose of dietary supplementation program? ›

The program's primary goal is to enhance and augment the quality and quantity of food and nutrient intake among its recipients. It prioritizes nutritionally vulnerable or undernourished pregnant mothers and children aged 6-23 months.

What are the DSHEA health claims? ›

DSHEA defines each dietary supplement health claim as follows. Structure/function claims “may describe the role of a nutrient or dietary ingredient intended to affect the normal structure or function of the human body, for example, 'calcium builds strong bones. '”

What are the key points of the Federal Food, Drug, and Cosmetic Act? ›

The FDCA authorizes the FDA with the following tasks, among many others:
  • Mandate drug manufacturers to submit evidence of new drugs' safety and effectiveness before marketing and distribution to the general public.
  • Issue and enforce quality standards for food, drugs, medical devices, and cosmetics.

What were the key elements of the Pure Food and Drug Act? ›

The Pure Food and Drug Act of 1906 prohibited the sale of misbranded or adulterated food and drugs in interstate commerce and laid a foundation for the nation's first consumer protection agency, the Food and Drug Administration (FDA).

What are the major components of the USDA Dietary Guidelines? ›

10 Guidelines
  • Aim for a healthy weight.
  • Be physically active each day.
  • Let the Pyramid guide your food choices.
  • Choose a variety of grains daily, especially whole grains.
  • Choose a variety of fruits and vegetables daily.
  • Keep food safe to eat.

What is a key element of the Nutrition Labeling and Education Act of 1990? ›

Nutrition Labeling and Education Act of 1990 - Amends the Federal Food, Drug, and Cosmetic Act (FDCA) to deem a food misbranded unless its label bears nutrition information that provides: (1) the serving size or other common household unit of measure customarily used; (2) the number of servings or other units per ...

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