Ayurveda, which is a traditional system of medicine, originated more than 3000 years ago. This field of medicine pays larger emphasis on building strength of mind and body to cope with different kinds of stressors and infections.[i] There are studies which suggest that ayurveda can reduce pain, manage with symptoms of type 2 diabetes, etc.[ii] Though this medicine has historical roots in India, it is relevant to the United States, where the market for Ayurvedic products is seen to be growing. Growing market means increasing advertisements and claims.
In USA, ayurveda is one of the practices under the umbrella term of “complementary and alternative medicine” (‘CAM’) along with other health care practices such as Chinese medicine, homeopathy, electropathy etc. The National Center for Complementary and Alternative Medicine (‘NCCAM’) is a center within National Institutes of Health. NCCAM defines CAM as “a group of diverse medical and health care systems, practices, and products that are not presently considered to be part of conventional medicine.”[iii] The term complementary has been used as a medicine being used with conventional medicines, whereas alternative medicines are medicines being used instead of conventional medicines. This area, according to U.S. National Center for Complementary and Integrative Health (‘NCCIH’) is being used by many Americans.[iv] This agency (NCCIH) is a federal agency charged with conducting scientific research on complementary and integrative health techniques. In addition, NCCAM reported that more than one-third of American adults use some form of CAM and visit CAM providers each year.[v] It was also reported that visits to CAM providers exceeds each year when compared to visits to primary care physicians.[vi]
Given the increasing use of CAM products in USA, FDA has also noticed increasing confusion as to whether these products are subject to Food, Drug, and Cosmetic Act (‘FD&C Act’) and/ or the Public Health Services Act (‘PHS Act’). To address this confusion, FDA provided a guidance document[vii] clarifying when a CAM product would be subject to FD&C Act or PHS Act. This guidance clarifies that depending on what the CAM therapy, practice, or product is, it may be subject to regulation as a drug, device, cosmetic, food (including additives and dietary supplements) or biological products under the PHS Act. These definitions could cover some of the CAM products. Secondly, CAM products are not exempted from regulation under FD&C Act or PHS Act. For example: if you are a producer and manufacturer of a vegetable juice which is being promoted for its optimal health benefits, this product would be regulated as ‘food’ in FD&C Act and FDA regulations, including hazard analysis and critical control point (HACCP), which is laid down in 21 CFR part 120.[viii]
Due to the vast array of CAM products, all having some unique features making it difficult for there to be a straight-jacketed formula on whether FD&C Act or PHS Act applies to them. However, the domain is subject to regulations under these statutes. If a product meets the statutory definition of drug, device, biological product, food, etc., it becomes subject to these regulations. For example, if there is a herbal tea which claims to treat arthritis in humans (intended use), it would be considered as a ‘biologically based practice” under the CAM domain and a “drug” under section 201(g)(1)(b) of FD&C Act. This is because of its intended use, which is to cure, mitigate, treat or prevent a particular disease in the human body. This herbal tea could also be perceived as a “new drug” under section 201(p)(1) of FD&C Act, unless it is generally recognized as safe and effective for use under the conditions prescribed, recommended or suggested in the labeling. If treated as a “new drug,” this tea would be required to meet Act’s premarket review and approval process by FDA. In the device hemisphere, there is an acupuncture which is a CAM therapy, but also uses needles which are regulated as a medical device by FDA. In this case, the acupuncture needles (21 CFR 880.5580) would be regulated by FDA as a medical device, however not the practice of acupuncture itself.
Hence, the guidance in ways addresses the question of whether FD&C Act and PHS Act have any impact on CAM products. If you need help in understanding if your complimentary or alternative medicine such as ayurveda, Chinese medicine etc. are to be regulated by the FDA, or are struggling with the application process for the administration’s approvals, EMMA International’s team of experts can help! Give us a call at 248-987-4497 or email info@emmainternational.com to see how we can help.
[i] Golechha M. Time to realise the true potential of Ayurveda against COVID-19. Brain Behav Immun. 2020 Jul;87:130-131. doi: 10.1016/j.bbi.2020.05.003. Epub 2020 May 7. PMID: 32389701; PMCID: PMC7204691.
[ii] National Center for Complimentary and Integrative Health, Ayurvedic Medicine: In Depth. Available at: https://www.nccih.nih.gov/health/ayurvedic-medicine-in-depth.
[iii] U.S. Food and Drug Administration, Complementary and Alternative Medicine Products and their Regulation by the Food and Drug Administration, Draft Guidance for Industry, available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/complementary-and-alternative-medicine-products-and-their-regulation-food-and-drug-administration.
[iv] National Center for Complimentary and Integrative Health, Complementary, Alternative, or Integrative Health: What’s in a name?, available at: https://www.nccih.nih.gov/health/complementary-alternative-or-integrative-health-whats-in-a-name.
[v] Institute of Medicine (2005), Complementary and Alternative Medicine in the United States, pages 34-35.
[vi] Id.
[vii] U.S. Food and Drug Administration, Complementary and Alternative Medicine Products and their Regulation by the Food and Drug Administration, Draft Guidance for Industry, available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/complementary-and-alternative-medicine-products-and-their-regulation-food-and-drug-administration.
[viii] Id.
