How Do FDA and FTC Regulate Ayurveda Products?

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Ayurvedic medicine, with its deep, historical roots in India, is still relatively new to the U.S. market-but growing quickly. For those unfamiliar with Ayurveda, it is an ancient Indian system of holistic medicine that combines the use of plants and herbs as medicinal treatment and a variety of lifestyle practices, including for diet and exercise. As the market has grown, so have advertising claims around ingredients or products with ties to Ayurvedic medicine.

In the U.S., practices such as Ayurveda, Chinese medicine, and homeopathy are referred to as “complementary and alternative medicine,” or CAM. According to the U.S. National Center for Complementary and Integrative Health (NCCIH), “many Americans-more than 30% of adults and about 12% of children-use healthcare approaches developed outside of mainstream Western, or conventional, medicine.”¹ In the U.S., NCCIH is the main federal agency charged with conducting scientific research on complementary and integrative health techniques.

FDA Clarifies Regulations for CAM Products

FDA has noted the rise of Ayurveda in the U.S. In particular, the agency says, as the market proliferates, there is increased confusion over how the Federal Food, Drug, and Cosmetic Act (FD&C Act, which governs food, drugs, and cosmetics), as well the Public Health Service Act (PHS Act, the law that gives FDA the authority to quarantine products arriving from foreign countries), apply to the Ayurveda category. In 2006, the agency aimed to dispel some confusion by publishing draft guidance, “Draft Guidance for Industry: Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration.”²

FDA’s CAM guidance states that Ayurveda products may indeed be subject to the FD&C Act as well as the PHS Act. Some CAM therapies or practices would fall under the scope of biological products under the PHS Act, or food, drug, or cosmetics (such as dietary supplements) under the FD&C Act.

As such, CAM products are not exempt from FD&C Act or PHS Act regulations. As FDA’s guidance explains, “This means, for example, if a person decides to produce and sell raw vegetable juice for use in juice therapy to promote optimal health, that product is a food subject to the requirements for foods in the [FD&C] Act and FDA regulations, including the hazard analysis and critical control point (HACCP) system requirements for juices in 21 CFR part 120. If the juice therapy is intended for use as part of a disease treatment regimen instead of for the general wellness, the vegetable juice would also be subject to regulation as a drug under the [FD&C] Act.”³ In short, FDA stressed, the agency applies the same statutory definitions to CAM products that it applies to conventional products.

What kind of enforcement actions has FDA taken against CAM products? The “Alternative Medicine Fraud” page on FDA’s website lists several warning letters the agency issued regarding CAM products relating to a variety of issues-most commonly, disease-treatment claims on products that are not approved drugs.⁴ Since the page was last updated in 2010, there have been additional warning letters⁵, safety alerts⁶, and import alerts posted⁷. 

In addition, in early 2015, FDA held a workshop to discuss the regulatory framework governing homeopathic products. Homeopathic products, which target holistic medicine, must meet the regulations of an FDA Compliance Policy Guide. While this guide does not require homeopathic products to have premarket approval, it does set forth a formal definition for homeopathic products as well as outline packaging and labeling guidelines.⁸

To date, no other FDA changes to the regulatory framework for CAM products have been announced.

FTC Increasingly Scrutinizing Substantiation

Following FDA’s homeopathic workshop, the FTC held its own workshop on homeopathic products in August 2015. The FTC’s primary interest in homeopathic products is to prevent unfair or deceptive advertising practices. Just as it has for other categories, the FTC has taken a primary interest in ensuring marketing claims are backed by adequate substantiation. The FTC also announced in late September that the agency will be issuing guidance relating to homeopathic products and claims as a follow-up to its 2015 workshop. 

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The FTC’s currently available guidance, “Dietary Supplements: An Advertising Guide for Industry,” speaks to “traditional use” claims, suggesting that marketers of traditional-use products look closely at how consumers perceive advertising claims and the degree of supporting evidence such claims require.⁹ The guidance also points out that it is important to avoid inferences that such products have been evaluated for efficacy if that is not the case. Also, the Guidance notes, “[as] consumer awareness of and experience with ‘traditional use’ supplements evolve, the extent and type of qualification necessary is also likely to change.”

The FTC also cautioned traditional-use products from making disease claims, noting that “an advertiser should not suggest, either directly or indirectly, that a supplement product will provide a disease benefit unless there is competent and reliable scientific evidence to substantiate that benefit.” The agency said it would “closely scrutinize the scientific support for such claims, particularly where the claim could lead consumers to forego other treatments that have been validated by scientific evidence, or to self-medicate for potentially serious conditions without medical supervision.”¹⁰

Historically, the FTC has not been very active in enforcing against “traditional use” claims; however, given recent FTC enforcement trends of looking closely at product and claims substantiation, it is foreseeable that the agency may take a conservative view of whether a claim based in traditional use can be properly substantiated. Companies marketing in this space will want to be sure to consider the forthcoming new guidance and the full body of available substantiation to determine whether the FTC’s “competent and reliable scientific evidence” standard can be met. 

Kristi Wolff is a partner in the Advertising and Food and Drug Law practice of Kelley Drye & Warren LLP.

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References:

1. https://nccih.nih.gov/health/integrative-health
2. www.fda.gov/regulatoryinformation/guidances/ucm144657.htm#f3
3. Id.
4. www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/medicationhealthfraud/ucm207747.htm
5. www.fda.gov/iceci/enforcementactions/warningletters/2016/ucm482627.htm
6. www.fda.gov/Food/RecallsOutbreaksEmergencies/SafetyAlertsAdvisories/ucm463159.htm
7. www.accessdata.fda.gov/cms_ia/importalert_1151.html
8. www.fda.gov/Drugs/NewsEvents/ucm430539.htm
9. https://www.ftc.gov/tips-advice/business-center/guidance/dietary-supplements-advertising-guide-industry
10. Id.