Cannabidiol (CBD) is a natural compound found in Cannabis Sativa plants, which include marijuana and hemp plants. Lately, there`s been a lot of hype around CBD-infused skin products. You can find it in cosmetics such as creams, lotions, balms, oils, face masks, shampoos and even bath bombs. Federal and state mandates regarding CBD continue to evolve. From a legal point of view, cosmetics companies should take into account that entering the CBD market is not without risk. The proposed federal cannabis and cosmetics laws reflect efforts that would significantly alter FDA regulations on conventional foods, supplements, and cosmetics, and are important reminders of the role lawmakers can play in addressing concerns about FDA authority. The question now is which concern – consumer access to CBD or cosmetic safety – will be addressed first. But a review of this summer`s legislative agenda highlights efforts to change the agency`s authority, as well as the food and cosmetics we`re seeing on shelves after the pandemic. In particular, efforts are focused on the FDA`s policy on the use of cannabis in conventional foods and supplements and the expansion of the FDA`s authority over cosmetics. 13. What is the FDA`s position on cannabis and cannabis-derived ingredients in cosmetics? The Food and Drug Administration (FDA) regulates cannabis and cannabis-derived compounds under the Federal Food, Drug, and Cosmetic (FD&C) Act (21 U.S.C. § 301 et seq.) like any other compound contained in any other FDA-regulated product.
On this basis, biologics, cosmetics, pharmaceuticals, food, pet food, medical devices, and tobacco products containing CBD or other hemp-derived components fall under the jurisdiction of the FDA and are subject to applicable laws and regulations administered by the agency, regardless of state laws. Ingredients derived from parts of the cannabis plant that do not contain THC or CBD may not fall within the scope of 301(ll) and may therefore be added to foods. For example, as discussed in question #12, some hemp seed ingredients may be legally marketed into human food. However, all food ingredients must comply with all applicable laws and regulations. For example, under the Act, any substance intentionally added to a food is a food additive and is therefore subject to pre-market review and FDA approval, unless the substance is generally recognized as safe by qualified experts under the conditions of its intended use (GRAS), or the use of the substance is otherwise excluded from the definition of food additive (§§§§§ 201(s) and §§ 409 of the FD&C Act [21 U.S.C. §§ 321(s) and 348]). Other than the three hemp seed ingredients mentioned in question #12, no other cannabis or cannabis-derived ingredients have been subject to a food additive application, GRAS notification, or otherwise approved by the FDA for use in foods. Food businesses that wish to use cannabis or cannabis-derived ingredients in their food are subject to the relevant laws and regulations that apply to all food products, including those related to food additives and GRAS processes. One. The FDA has sent warning letters in the past to companies that illegally sell CBD products that claimed to prevent, diagnose, treat, or cure serious diseases such as cancer. Some of these products also violated the FD&C Act because they were marketed as dietary supplements or because they included the addition of CBD to foods.
However, unlike the other categories described above, cosmetics (and most ingredients used in the manufacture of cosmetics) are generally not subject to pre-market approval by the FDA. For this reason, a cosmetic containing hemp-derived CBD may be manufactured, marketed, and sold to consumers without prior express «approval» or «approval» from the FDA, provided that the use of CBD and other ingredients used in the manufacture of cosmetics is safe. The FDA reserves the authority to prohibit or restrict the use of certain ingredients in the manufacture of cosmetics (a so-called «negative list») through regulation, but at the time of this article, cannabis, hemp, and CBD do not currently appear on this list. Now that cannabis is legal in much of the U.S. (medical marijuana in 33 states and recreational cannabis in 10 plus Washington DC), more people have had the opportunity to experience the plant in a whole new way. «Word of mouth about CBD has spread like wildfire,» says Cindy Capobianco, co-founder of Lord Jones, a chic brand of infused treats available nationwide at standard hotels and SoulCycle studios. «Enthusiasm and education about CBD is destigmatizing and normalizing the cannabis plant faster than we could have ever imagined.» Unlike congressional efforts to circumvent the FDA`s current regulatory approach to cannabis, other congressional activities are aimed at further empowering the agency to actively regulate cosmetics. Beginning in 2014, Congress gave states special authority to approve the cultivation and cultivation of «industrial hemp» under agricultural pilot programs. Industrial hemp was specifically defined in the 2014 Farm Bill to include Cannabis sativa L.
containing less than 0.3% THC on a dry weight basis, creating a distinction between hemp and marijuana under certain federal regulations, including those administered by the United States Department of Agriculture (USDA). It wasn`t until the 2018 Farm Bill was passed that Congress effectively removed hemp from the legal definition of marijuana, exempting hemp from inclusion as a Schedule I controlled substance under current DEA regulations.1 The 2018 Farm Bill further eased restrictions on cultivation, Hemp cultivation and distribution, allowing individual states to implement licensing programs (in accordance with USDA regulatory requirements) for individuals. Cultivation, processing and distribution of hemp and hemp products. Therefore, following the implementation of the 2018 Farm Bill and subject to applicable federal and state requirements, hemp containing less than 0.3% THC is legal in all 50 states. Notably, the 2018 Farm Bill represents a lower limit, not a cap — states are allowed to implement more restrictive requirements regarding the production, sale, and labeling of hemp and hemp products, including those containing CBD. Authorized for use in cosmetics (if THC does not exceed 0.2%) Overall, this ingredient is attracting great interest from the cosmetics industry as a source of innovation. However, there is still no well-established legal framework defining what can be done with it; However, it is clear under what conditions we are not allowed to use it. One.
It depends, among other things, on the intended use of the product and how it is labelled and marketed.