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How Marketplaces Can Maintain Compliance With DSHEA Guidelines

The FDA and FTC coordinate the enforcement of DSHEA guidelines in the somewhat tumultuous regulatory environment of dietary supplements. Discover what DSHEA guidelines are and how online e-commerce marketplaces can mountain compliance.Then contact us for a quick strategy session.

The FDCA Was Amended by the Dietary Supplement Health and Education Act (DSHEA) to Include Guidelines for Supplements

In 1994, legislation was introduced to amend the Federal Food Drug and Cosmetics Act (FDCA) titled the Dietary Supplement Health and Education Act (DSHEA). It was amended to “establish standards with respect to dietary supplements.” It’s typically enforced by the US Food and Drug Administration (FDA) as well as the Federal Trade Commission (FTC) underneath the Memorandum of Understanding.

According to the Memorandum of Understanding, “The FTC and the [FDA] share jurisdiction over the marketing of dietary supplements, foods, drugs, devices, and other health-related products. The agencies coordinate their enforcement and regulatory efforts.”

Here’s What E-commerce Online Marketplaces Need to Know to Maintain Compliance with DSHEA's Guidelines

The burden of proof lies with the FDA. Each of the sections listed under DSHEA establish firm guidelines for claims including but not limited to:

The burden of proof is on the FDA: “If it is a dietary supplement or contains a dietary ingredient that … presents a significant or unreasonable risk of illness or injury, is a new dietary ingredient for which there is inadequate information to provide reasonable assurance, the Secretary declares to pose an imminent hazard to public health or safety, and/or contains a dietary ingredient that renders it adulterated … under [those] conditions of use recommended or suggested [on] the labeling of such dietary supplement[s].”

A dietary supplement must include notice on the labeling in instances including but not limited to: if the ingredients present a significant risk; and/or the Secretary declares it a public health or safety hazard; and/or it contains a dietary ingredient that renders it adulterated. Do you want to stay on top of dietary supplement ingredients? Download your free copy of our Top 10 Problematic Ingredients Guide.

Statements of nutritional support: “[Dietary supplements] may not claim to diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases. If the manufacturer of a dietary supplement proposes to make a statement as described … [on] the labeling of the dietary supplement, the manufacturer shall notify the Secretary no later than 30 days after the first marketing of the dietary supplement with such statement that such a statement is being made.”

A greater reliance on e-commerce in recent years has brought many new merchants online who may be unaware of the limitations on how they can describe supplements and their effects. Any seller is at risk of making deceptive or problematic marketing claims, which is why it’s important for marketplaces to understand what supplement sellers can and can’t say. Watch our webinar on problematic claims to learn more.

How Marketplaces Must Maintain Compliance with DSHEA Guidelines — and the FTC

The Federal Trade Commission Act empowers the Federal Trade Commission (FTC) to “prescribe rules defining with specificity acts or practices that are unfair or deceptive, and establishing requirements designed to prevent such acts or practices.”

According to the Health Products Compliance Guidance published in December 2022, “law requires online e-commerce marketplaces ‘to identify all claims the advertising materials communicate to reasonable consumers. Once the claims are identified, the FTC assesses the scientific evidence upon which the company relies to determine whether there is adequate support for those claims.’”

Furthermore, the FTC monitors dietary supplement health claims by:

  • Identifying claims and interpreting ad meaning
  • Substantiating claims
  • And addressing other advertising issues

Changes to DSHEA Could Be on the Horizon

In the FDA’s Summary of FY 2024 Legislative Proposal it states “The FDA is seeking to modernize DSHEA to provide for a transparent marketplace, help facilitate a risk-based regulation of dietary supplements, and clarify FDA’s authorities relating to products marketed as ‘dietary supplements’”.

Download How the FDA’s Proposal to Modernize DSHEA Could Impact Supplement Regulation to learn more.

LegitScript Marketplace Monitoring Helps Marketplaces Follow DSHEA Guidelines

Are you an e-commerce marketplace looking to ensure they’re maintaining compliance with DSHEA? LegitScript Marketplace Monitoring helps you reduce the risk of problematic listings by monitoring your marketplace using the largest database of high-risk and problematic products on the commercial internet. We track 175+ regulatory bodies across 100+ countries in 60+ high-risk areas. Confidently grow your business into new product categories and jurisdictions while eliminating false positives.

Contact us for a quick strategy session.