The popularity of hemp grew exponentially with the passage of the 2018 Farm Bill (“Farm Bill”). Per the definition section of the Farm Bill, hemp, with a concentration of no more than 0.3% of Tetrahydrocannabinols (“THC”), on a dry weight basis (also known as cannabidiol or “CBD”), was removed from the controlled substances list. As a result, businesses rushed to produce products that include hemp as an ingredient. Hemp products containing more than 0.3% THC continue to be classified as illegal marijuana. Businesses investing in hemp advertising are tempted to boast about the efficacy of their products to consumers. However, before doing so, businesses should get familiar with regulations related to hemp product advertising.
Are businesses allowed to advertise the efficacy of their hemp products?
FDA and FTC Advertising Regulations
The U.S. Food and Drug Administration (“FDA”) and the Federal Trade Commission (“FTC”) are the primary regulatory bodies that oversee hemp product advertising. The Farm Bill explicitly preserved the FDA’s authority to regulate products containing cannabis or cannabis-derived compounds under both the Federal Food, Drug and Cosmetic Act (the “FD&C Act”) and Section 351 of the Public Health Services Act (the “PHS Act”). The FDA regulates products that are intended to affect the structure or function of the body, or are used to diagnose, cure, mitigate, treat or prevent disease. Products that fall under this umbrella may come under FDA scrutiny if the products are labeled in a false or misleading way, do not bear required labeling information, or are otherwise produced or packaged in a deceptive manner.
The FTC prohibits product advertising that includes claims that the subject products prevent, treat, or cure human disease, unless the product seller has competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, that substantiate that the claims are true when made. Additionally, to make or exaggerate such claims, whether directly or indirectly, through the use of a product name, website name, metatags, or other means, without rigorous scientific evidence sufficient to substantiate such claims is a violation of FTC regulations and businesses that do so, may soon find themselves investigated by the FTC.
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Hemp Advertising
Businesses that advertise that their hemp infused products can diagnose, cure, mitigate, treat or prevent disease risk receiving warning letters from the FDA and/or FTC. Examples of language that the FDA and FTC have found to be evidence that the intended use of the product was to diagnose, cure, mitigate, treat or prevent a disease include: “for chronic pain,” “reduces inflammation” and “supports healthy sleep.” However, because hemp seeds themselves do not naturally contain any THC, the FDA has treated products containing only hemp-seed derived ingredients in a different way. Hemp seed products may be treated as homeopathic remedies that receive a different level of scrutiny from the FDA and FTC for products that are intended solely for conditions that can be resolved spontaneously with or without specific treatment and are open to self-diagnosis. The FDA’s top concern is consumer safety. As such, the FDA will bring enforcement action against homeopathic product sellers if there is reason to question the safety of a given product. Similarly, the FTC does not exempt homeopathic products from the prohibition against making misleading claims on packaging. However, packaging that includes a disclaimer that: (1) there is no scientific evidence that the product works; and (2) the product’s claims are based only on theories of homeopathy (from the 1700s that are not accepted by most modern medical experts), may prevent associated efficacy claims from being considered misleading.
In addition to federal regulations, businesses must be aware of how each state regulates hemp products and hemp advertising. Businesses should consult with experienced marketing attorneys before bringing hemp products to market or risk federal and state regulatory action.
If you need assistance reviewing your hemp advertising, please e-mail us at info@kleinmoynihan.com or call us at (212) 246-0900.
The material contained herein is provided for informational purposes only and is not legal advice, nor is it a substitute for obtaining legal advice from an attorney. Each situation is unique, and you should not act or rely on any information contained herein without seeking the advice of an experienced attorney.
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