People checking off list on clipboard surrounded by dietary supplements

Dietary Supplements Regulatory Updates Amid COVID-19

Denis Storey
May 29, 2020

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More than three-quarters of American adults take dietary supplements regularly. These products, which can include anything from multivitamins to botanicals, are treated differently than food and beverage products by the FDA.

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Whether it’s the impact on the economy, the latest number of cases, or predictions about what’s coming next, it’s impossible to escape the pandemic.

Last year, dietary supplement sales reached a record of $48.7 billion. Sales have continued to rise, with people looking for alternatives to stay healthy, keeping supplement makers extremely busy, and potentially missing a few critical regulatory updates.

ODS Releases 2019 Annual Report

When Congress passed the Dietary Supplement Health and Education Act (DSHEA) of 1994, it changed the game for dietary supplements in America.The landmark legislation classified dietary supplements as a special category of food. It directed the Secretary of the Department of Health and Human Services (HHS) to establish the Office of Dietary Supplements (ODS) within the National Institutes of Health (NIH).

The ODS focuses on strengthening knowledge of dietary supplements in America, particularly the concept that nutrients and other natural substances might benefit health beyond essential nutrition. 

Each year, the ODS releases an annual report, detailing key accomplishments and research findings. The 2019 ODS Annual Report outlined several new developments.

The ODS continues to deliver against its 2017-2021 strategy plan with several key accomplishments in 2019.

Highlights include:

  1. Grants: In 2019, ODS co-funded 59 grants worth more than $10 million, and six Scholar’s Projects valued at $450,000. These included studies of more than two dozen administrative supplements and two single laboratory validation administrative supplements. These funding mechanisms allow investigators, including junior scientists, to expand their NIH-funded projects’ scientific scope to include studies related to dietary supplements.

  2. CARBON Program: The ODS supports the Centers for Advancing Research on Botanical and Other Natural Products (CARBON) Program, running it jointly with the National Center for Complementary and Integrative Health (NCCIH). The program supported the development of three new methods. The first is for purifying different flavone glycosides, a prerequisite for determining whether they have various biological activities. The second is a set of procedures for turmeric extract preparations with very different chemistries, required deciding which turmeric components contribute to biological activities. The last is an analytical method for quality control, using nuclear magnetic resonance (NMR) to check the amino acid sequence and peptide drugs’ content.

  3. Validation Methods: Ongoing collaboration between ODS and the USDA Methods and Food Composition Laboratory has spearheaded improved guidelines for validating methods to identify and authenticate botanical materials commonly used in dietary supplements.

  4. DLSD: The ODS supports the development of a dietary supplement label database (DSLD). About 1,000 new labels per month were added to the DLSD in 2019, reaching 98,863 labels by the end of the year. The ODS is working on a visualization project to improve the DSLD graphic interface for quick and advanced search results. In addition to a spreadsheet, search results will also be available in a graphic format.

  5. Dietary Research: To identify gaps in dietary intakes, ODS continues to compare adult multivitamin-mineral and prenatal supplement content to actual nutrient needs. ODS staff are also developing a case for prenatal supplements and supplements, making weight-loss claims, prebiotic and probiotic supplements, and fiber supplement claims.

  6. Public Inquiries: ODS staff responded to 567 public inquiries in 2019; roughly two-thirds of these inquiries were about vitamins and minerals. Last year’s inquiries required the most significant number of responses since the program began.

FTC Announces Refunds

In other regulatory news, the Federal Trade Commission announced that it’s mailing 22,581 refund checks worth more than $470,000 to U.S. consumers who bought two health products the agency called deceptively marketed: TrueAloe and AloeCran, both produced by NatureCity. The average amount of each check is $20.83.

According to the FTC’s complaint, filed in October 2019, “the Florida company deceived consumers with claims that TrueAloe and AloeCran were effective treatments for a range of conditions affecting seniors, including chronic pain, ulcerative colitis, diabetes, and acid reflux.”

The FTC charged that the company’s claims were deceptive and not supported by competent and reliable scientific evidence. Additionally, the FTC asserted the company used testimonial reviews by seemingly independent users but failed to disclose those reviewers received free products or free lifetime memberships as compensation.

The court order resolving the complaint bars the company from making false and unsubstantiated health claims and requires them to pay $537,500 to finance the consumer refunds.

“The FTC has shown over and over that it will go after companies we believe are peddling false health claims about their pills and potions,” said Andrew Smith, Director of the FTC’s Bureau of Consumer Protection. “Our settlement with NatureCity is the latest example, and we’re especially concerned that the company targeted older adults and tried to steer them away from standard medical treatments.”

FDA’s COVID-19 Supplement Industry Response

The FDA remains responsible for overseeing the dietary supplement industry during COVID-19. However, to protect its employees, some routine facility inspections have been postponed. With that said, the FDA continues “for-cause inspection assignments” deemed “mission-critical.”

On a related note, a trio of leading supplement trade organizations – the Council for Responsible Nutrition (CRN), the United Natural Products Alliance (UNPA), and the Consumer Healthcare Products Association (CHPA) – sent a letter to the ODS proposing a framework for a New Dietary Ingredients (NDI) master file. The letter explained that such a tool would “streamline the collection and protection of data investments made by ingredient manufacturers.” It provides a way to keep confidential information secure such as safety data related to an NDI and enables companies to authorize others to properly reference master file data. 

Without proof of authorization, a company cannot claim to have the same ingredient as another. With the NDI-MF use, the FDA can identify and enforce against specific marketing of NDIs that fail to comply with the notification to reference master file data properly. Regulators are still on the job, and consumer safety remains the top priority. Companies must always be accountable for their products' quality and consistency to maintain customer satisfaction and safety, and adhering to regulatory requirements is as critical as ever.

Find out how TraceGains can help your supplements company stay compliant by downloading this helpful eBook, “Dietary Supplements: A New Era of Compliance and Standardization.”