HEALTH & WELLNESS
Robison Law Group has extensive experience in the cosmetic sector with clients that source hemp products domestically and from abroad. From startups to established retail vendors, our practice advices an expansive group of stakeholders.
Whether your question is about compliant labelling, what ingredients can be used in cosmetic products, or what prior authorization, if any, is required from the Food and Drug Administration (FDA), Robison Law Group provides answers . . . . and solutions.
Generally, sellers of hemp, CBD and other cannabinoids based cosmetic and body care products should substantiate the safety of the finished cosmetic as labeled or in a customary or expected way. This includes compliance with FDA regulations on prohibited and restricted ingredients. Those currently in effect, 2019, do not appear to prohibit the use of hemp and its compounds in cosmetic products.
A central aim of the FDA is to ensure that human and veterinary drugs, vaccines, and other biological products and medical devices intended for human and animal use are safe and effective. The agency maintains an expansive compliance regime that regulates the pharmaceutical industry. As many stakeholders in this industry know, medical and advertising claims are highly regulated.
State and federal regulatory and legislative frameworks affect clients that work with "hemp" and marijuana derived cannabinoids. Pharmaceutical approaches to developing cannabinoid-based products can differ vastly depending on the source and use.
While the roles of the FDA and the DEA often overlap, the DEA regulates controlled substances and drug-paraphernalia. From assisting clients with seizures to obtaining licenses to work with controlled substances, Robison Law Group counsels clients who need to navigate these complex matters.
The FDA’s position remains unchanged: even though hemp has been removed from the Controlled Substance Act does not mean that stakeholders may use it in food or supplements or infer that it is a drug or medicine. At its core, the FDA is concerned about drug claims and public health issues. At the same time, the FDA has held a consistent opinion that there are only limited ways to introduce hemp and hemp containing products into interstate commerce: (1) adequate and well-controlled clinical studies; (2) the FDA has authority to issue a regulation allowing the use of a pharmaceutical ingredient in a food or dietary supplement and this is currently under evaluation; and (3) certain parts of the plant are generally recognized as safe (GRAS) under for use in foods.
Robison Law Group has experience in obtaining Schedule I-V licenses for stakeholders that would like to work with marijuana on under the existing federal regime.
CBD and other cannabinoids (including THC) have become popular with professional and amateur athletes alike. Many believe that certain cannabinoids reduce recovery times, increase stamina and help manage pain and inflammation. CBD are thought to be a healthier solution than opiates and NSAIDS. Naturally, athletes want to consume a substance that is good for them and does not run a risk of addiction.
The axiom “everybody is doing it; it must be legal” comes to mind. The supplement industry is highly nuanced and an understanding of the Federal Trade Commission (FTC), Food & Drug Administration (FDA) and Customs & Border Protection (CBP) administered regulation is fundamental.
The FDA asserts, that “Based on available evidence, FDA has concluded that cannabidiol products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(ii) of the FD&C Act. FDA considers a substance to be 'authorized for investigation as a new drug' if it is the subject of an Investigational New Drug application (IND) that has gone into effect. Under FDA's regulations (21 CFR 312.2), unless a clinical investigation meets the limited criteria in that regulation, an IND is required for all clinical investigations of products that are subject to section 505 of the FD&C Act. There is an exception to section 201(ff)(3)(B)(ii) if the substance was 'marketed as' a dietary supplement or as a conventional food before the new drug investigations were authorized. However, based on available evidence, FDA has concluded that this is not the case for cannabidiol.”
If this is correct, how is it that there are hundreds, if not thousands, of businesses that market their hemp-based products as supplements or dietary supplements? Many of these businesses state that the FDA is simply plain wrong about CBD being marketed as a dietary supplement prior to the authorization of an IND. Others are risk takers and do not think the FDA and FTC will do anything. Regardless of your position, experienced legal representation mitigates the risk of conducting business, research and other activities in these fields. The Group counsels its clients on best practices and compliance with applicable law.
Dietary supplements are available on the internet, in smoke shops, in natural food stores, and through retailers. Robison Law Group works with all types of stakeholders, each having nuanced legal challenges. It offers the following services:
- Labeling best practices
- Identifying prohibited and restricted ingredients
- Responding to state and federal agencies
- Permissible claims
- Organic claims
- GMO Claims
- Diet Related Claims
- Impermissible structure function claims
- Warning statements
- FDA Importation Process
- Advertising best practices
- Responding to warning letters and avoiding getting them
- Dietary Supplement Health and Education Act of 1994 (DSHEA) counseling