Using Caution with Claims

Male hand holding craft envelope with text WARNING on blue background, concept

With demand for immune support products soaring, FDA and FTC are on alert, monitoring the market for products that made fraudulent prevention and treatment claims. To help brands navigate, the American Herbal Products Association (AHPA) covered the topic in-depth at its 2021 AHPA Congress on Immune Supplements: Regulatory and Research Strategies. Presenting at the event, Cameron Smith, Esq., Senior Director, Counsel, Herbalife Nutrition, outlined the joint FDA/FTC actions taken against marketers, including warning letters to marketers who made:

  • specific reference to COVID-19.
  • an implied connection with COVID by urging consumers to take action in response to current circumstances. For example: “the time to boost your immunity is now.”

While structure/function claims can discuss the support or maintenance of the body’s normal processes, and can include details of the system being supported, Smith stressed that making a claim about the role of specific parts of the immune system (such as “increasing T-cells and B-cells….respond quickly and aggressively to…infection”)
is “perilous.”

Making such claims, he said, could trigger a warning letter…or worse. Smith offered more examples of what not to do when focusing on immune health, including:

  • Mentioning any antiviral or antibacterial role of the immune system.
  • Discussing improvement of immune function after compromise through disease.
  • Referencing colds, flu, or other diseases by name (for example: “specific for boosting immunity against colds and flu”).

As Rakesh Amin of Amin Talati Wasserman LLP pointed out in the January issue of WholeFoods, the concern over claims isn’t limited to immune support. He cautioned that Plaintiffs’ lawyers are attacking claims related to:

  • structure/function benefits
  • protein content
  • “zero” and “no sugar”
  • “no artificial flavor”
  • fruit flavor (variant on vanilla suits)
  • “no artificial colors”
  • ingredient permissibility (alleging products are not “dietary supplements” where no new dietary ingredient notification was filed for the ingredient)
  • product classification (ie. CBD supplement/food challenges).

To mitigate risk, Amin stresses that companies should only make claims that match the science and are substantiated with competent and reliable scientific evidence, and review labeling and marketing materials from the vantage point of the “reasonable consumer” (not merely technical labeling compliance). Being proactive in thinking this all through is essential. As Amin notes, “An ounce of prevention is worth ten pounds of cure nowadays, and developing war chests filled with strong defensible positions is important for long term sustainable growth.”

Offering more insights to help brands work through the necessary steps in formulating lawful claims, Ruth Rodrigues of Nutrasource presents an outline in Concept to Claim: An abbreviated guide for dietary supplement brands. Rodrigues says there are three critical components to successful marketplace access:

  1. Addressing key research questions to help in connecting the science and realizing marketing objectives
  2. Performing a comprehensive literature review, which informs product development teams of strengths and weaknesses of the product and highlights product potential.
  3. Knowing your options when it comes to claim substantiation as well as what to avoid in order to streamline the workflow stay on track.

Access the links above for more legal insights and claims advice on www.WholeFoodsMagazine.com.