10 Misconceptions About Dietary Supplements Regulation

10 Misconceptions About Dietary Supplements Regulation

Denis Storey
October 2, 2020

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Some industries manage to thrive during even the worst economic downturns, such as discount retailers, health care, and dietary supplement manufacturers. At the height of the housing crash, sales of dietary supplements jumped 5% through June 2009.

“In the 52 weeks ending March 8, 2020, the total [supplements] market was up more than 6%,” Joan Driggs, vice president of thought leadership and content for market research firm IRI, told Nutritional Outlook. “That’s a pretty healthy leap for the category.”

 

When the United States woke up to the severity of the coronavirus pandemic, in the weeks leading up to March 8, 2020, overall dietary supplements growth surged more than 35%.

 

This increased demand naturally attracts bad actors, particularly in an industry many see as an unregulated free for all. But, as Len Monheit, Executive Director at the Global Prebiotic Association and CEO of the Trust Transparency Center, points out, nothing could be further from the truth. Monheit spells out ten ways the supplements industry is regulated:

 

  1. The U.S. Food and Drug Administration (FDA) supervises food, drugs, and supplements under the Food Drug and Cosmetic Act of 1938. The FDA has the power to recall products or ingredients it deems a safety threat or risk to public health, inspect facilities, take manufacturers to court, seize products upon import, and other actions to fulfill its obligations and responsibilities to consumers.

  2. The dietary supplements industry falls under the jurisdiction of DSHEA, the Dietary Supplements Health and Education Act, which Congress passed in 1994. DSHEA established a new regulatory environment for supplements as a subset of foods. When detractors claim the industry is unregulated, they usually mean it’s not regulated as “drugs.” This claim is valid because supplements aren’t drugs — DSHEA is specific for supplements and gives loads of authority to the FDA, as they have claimed and proven.

  3. Regulators also oversee dietary supplement manufacturing. In 2007, the FDA released its Good Manufacturing Practices rule for dietary supplements. This rule covers processes, operations, product quality, and other aspects of production, storage, handling, and product quality. Since that time, inspectors have reviewed hundreds of facilities each year, several on multiple occasions.

  4. We often hear of the FDA and other bodies noting that supplements are found to be adulterated with undeclared drugs, usually in the classes of weight loss, sports performance, and sexual enhancement products. This adulteration is illegal, and technically, these products are misbranded as supplements. That is, they’re not allowed to be presented as supplements if these ingredients are found in them. Frequently, mainstream media – among others – will claim this is a supplements industry issue, but again, these products can’t be classified as supplements to start with. The same applies to products containing steroids. This adulteration was specifically covered first in the Anabolic Steroid Act of 2004, and then subsequently in the Designer Anabolic Steroid Control Act of 2014, to cover new and emerging anabolic steroids masquerading as supplements.

  5. Many believe there’s no control over what claims a supplements company can make associated with its product. This is covered a couple of different ways. A supplements company is required to notify the FDA of claims it intends to make within 30 days of that product entering commerce. If a company makes unsubstantiated or misleading claims, it’s subject to FDA and/or Federal Trade Commission (FTC) action.

  6. The FTC has responsibility for the handling of consumer protection in all goods categories. Specifically, all claims made must be substantiated (the company, when called upon, must be able to provide evidence of this), and all claims must be truthful and not misleading (open to incorrect interpretation or be confusing). On its own initiative, or through consumer or market applications through various mechanisms, the FTC can and does investigate egregious claims, taking companies to court and other actions to cause claims to be changed or eliminated. In some cases, fines and redress are significant.

  7. Drug claims, that is claims that a dietary supplement product cures, mitigates, or prevents disease are expressly prohibited and remain illegal. Claims allowed under DSHEA are called structure/function claims and generally use language such as “supports” or “promotes.” The FDA does have several approved health claims for all foods, including dietary supplements.

  8. Detractors say there’s no review for ingredient or product safety for dietary supplements. A more accurate assessment is that there’s no pre-market approval for dietary supplements. However, there is a pre-market submission and review of new dietary ingredients required under the law. This process, known as a New Dietary Ingredient (NDI) notification, requires the company bringing the new ingredient to the market, once identifying it as new (if it’s not new, it’s presumed covered as a grandfathered ingredient under DSHEA) to submit a dossier to the FDA showing it is safe. The FDA ultimately responds to these notifications not with “approval,” but rather a “no objections” statement and indication. This process is specific and unique to the ingredient and processes of the manufacturer. Another way to show ingredient safety that many companies use is to follow what’s known as Generally Recognized as Safe (GRAS) affirmation as a food ingredient (or known in the food supply), a less rigorous and sometimes more expedient process. Both processes are intended to be before commercial availability of the ingredient, and both are dose-specific.

  9. Many frequently claim that no authority, especially the FDA, can get a product off the market, even if it’s shown to present a health or safety risk. This accusation is not true. A specific example is in the case of the ingredient ephedra, removed from the market when the FDA, in 2004, banned the sale of supplements containing ephedrine alkaloids. In another example, the FDA issued a recall in 2009 for 14 products associated with the brand Hydroxycut. This product was subsequently reformulated and reintroduced. Other risk-presenting supplements have also been recalled under FDA orders.

  10. Most consumers believe dietary supplements are safe, and the data supports this. Furthermore, in 2006, lawmakers amended the Food, Drug, and Cosmetic Act to require supplements companies to report serious adverse events (SAEs) to the FDA within 15 days and keep records of all non-serious events for six years. This amendment has provided, arguably for the first time, evidence that the category is safe, considering that more than 70% of U.S. consumers take some form of dietary supplement.

To read Monheit’s entire article, click here.

 

Dietary supplements manufacturers need to be vigilant when it comes to their language when marketing their products, ensuring all claims are substantiated. It’s also essential to maintain complete supply chain visibility so they can better manage their risk.

 

TraceGains helps dietary supplement companies bring all their data and information required for formula and recipe development together in one place while streamlining and automating business processes so teams can work smarter. Join TraceGains for a complimentary webinar, "Faster New Product Development for Supplements Brands" on October 22. Register here

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