FDA has authority to regulate hemp-based products than contain CBD and any amount of THC (even THC concentration less than .3 percent). This includes foods, drugs, cosmetics, dietary supplements, and any other substances and ingredients under its authority.
Manufacturers, distributors and sellers need to understand FDA compliance requirements. If the companies fail to meet the requirements, such cannabis businesses could receive warning letters from FDA. FDA warning letters will normally give the company a minimal time to come into compliance with the warning letter. If the company fails to come into compliance the business will likely face fines and penalties. These cannabis companies will also likely be forced to close their doors.
An experienced FDA lawyer can explain FDA compliance rules for cannabis-derived products and guide your cannabis companies through the byzantine compliance process.
FDA’s position on cannabis and cannabis-derived ingredients in cosmetics
The FD&C Act defines a cosmetic, in Section 201(i) as:
“(1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap.”
Lotions are generally considered cosmetics.
Cosmetic products do not require Food and Drug Administration (FDA) approval unless they have color additives or unless the qualify as a drug, medical device, or dietary supplements. There are […]
Except for color additives, the FD&C Act does not require FDA premarket approval of cosmetic products and ingredients.
Currently, cannabis and cannabis-derived ingredients, according to FDA (link), are not prohibited or restricted by regulations. Even though cannabis ingredients don’t appear to be covered by any current regulations, the ingredients must meet the general applicable requirements – which means cannabis and cannabis-derived ingredients cannot cause the product to be adulterated or misbranded in any way.
- Adulteration. Cosmetics are considered adulterated, under the FD&C Act, if:
- The cosmetics “bear or contain any poisonous or deleterious substance which may render the cosmetic injurious to users under the conditions of use prescribed in the labeling, or under such conditions of use as are customary or usual (section 601(a) of the FD&C Act [21 U.S.C. § 361(a)]).” or
- The cosmetic is intended to “affect the structure or function of the body, or to diagnose, cure, mitigate, treat or prevent disease, the product is a drug, or possibly both a cosmetic and a drug, even if the product affects the appearance.”
- Other conditions regarding how the cosmetic was prepared and packed including the container may also apply
- Misbranding. A cosmetic is misbranded if “the cosmetic’s labeling is false or misleading in any particular.” Misbranding also applies to a cosmetic if:
- The cosmetic’s label does not include all required information.
- The required information is not adequately prominent and conspicuous;
- The container is misleading
- “The cosmetic is a color additive, other than a hair dye, that does not conform to applicable regulations issued under section 721 of the FD&C Act”
- The cosmetic’s packaging or labeling violated the Poison Prevention Packaging Act
Cosmetics include: – “skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup, cleansing shampoos, permanent waves, hair colors, and deodorants, as well as any substance intended for use as a component of a cosmetic product.”
“If the product is intended for a therapeutic use, such as treating or preventing disease, or to affect the structure or function of the body, the product is a drug (FD&C Act, 201(g)), or in some cases a medical device (FD&C Act, 201(h)), even if the product affects the appearance. Other “personal care products” may be regulated as dietary supplements or as consumer products.
OTC Drugs and Cannabis
No FDA approved drugs can contain CBD other than Epidiolex, Marinol and Syndros. FDA states that is aware companies are marketing CBD products for therapeutic uses and the ability to treat disease. In response to these marketing efforts, warning letters have been issued to the firms. And products which have the aim of providing a medical or therapeutic use and “any product (other than a food) that is intended to affect the structure or function of the body of humans or animals, is a drug.”
Approval as a drug under the FD&C Act generally requires either:
- FDA premarket approval – through the New Drug Application (NDA) process
- Or the product must conform “to a monograph’ for a particular drug category, as established by FDA’s Over-the-Counter (OTC) Drug Review.”
Questions and answers by the Food and Drug Administration regarding the regulation of CBD products for medical uses, for drug uses, use as dietary supplements, and for other uses.
Drugs that have not been approved by FDA cannot be distributed or sold in interstate commerce.
Companies that sell products that have not been FDA approved endanger patients in addition to being in violation of FDA regulations and rules.
FDA considers unproven treatments as “raising significant public health concerns, because patients and other consumers may be influenced not to use approved therapies to treat serious and even fatal diseases.”
FDA concerns about unapproved drugs of any king, including cannabis and products with cannabis ingredients, include concerns about:
- Whether the drugs work
- What the correct dosage may be if – even if the drugs do work
- How the product/drug interacts with other drugs
- Whether there are dangerous side effects of other safety issues
FDA does indicate that the Agency welcomes speaking with states that are considering how cannabis and cannabis derivatives can be used in medical research – so FDA information on federal and scientific standards can be reviewed. FDA emphasizes medical research is required and should be conducted through properly controlled scientific clinical trials – to help determine the safety of these cannabis products.
Dietary supplements and THC or CBD products
“Based on available evidence, FDA has concluded that THC and CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B) of the FD&C Act [21 U.S.C. § 321(ff)(3)(B)].”
“Under that provision, if a substance (such as THC or CBD) is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act [21 U.S.C. § 355], or has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are excluded from the definition of a dietary supplement. “
FDA’s policy is that a substance is “authorized for investigation as a new drug” if an Investigational New Drug applications (IND) has gone into effect. An IND is necessary for all clinical investigations of products under Section 505 of the FD&C Ac – unless a clinical investigation meets the limited criteria” in the appropriate regulations.
Based on available knowledge FDA has determined that neither THC nor CBD meet the exception which applies for substances that were “marketed as” a dietary supplement or as a conventional food before the drug was approved or before the new drug investigations were authorized.” FDA review to date has not found any reason to change the Agency’s positions that CBD and THC products are excluded from the FD&C Act definition of a dietary supplement. This means that CBD and THC products do NOT qualify as dietary supplements, much as many in the cannabis industry are marketing their products in this way.
How to Respond to an FDA Warning Letter about Dietary Supplements or Cosmetics
The United States Food and Drug Administration (FDA) regulates much more than food and drugs. It regulates dietary supplements, cosmetics, medical devices, tobacco products, animal food, […]
Medical Device
Thus far, the literature regarding use of cannabis in medical devices has been scant.
What claims can you make and not make
As a general rule: makers, distributors, and sellers of cannabis and cannabis-based products need to be extra circumspect about the claims they make for at least two reasons:
- First, the claims may convince FDA that the category the manufacturer used to describe the products should be the drug category. For example, products that state the lotions, creams, foods, or supplements have therapeutic and medicinal value will likely be reclassified by FDA as adulterated products which should properly be classified as drugs. FDA approval for drugs generally requires very rigorous scientific testing.
- Second, the claims may be considered “misbranding” because the claims make promises that simply are not truthful.
All of this will likely lead to FDA enforcement action.
What will FDA do if the Agency believes your cannabis or cannabis-related products violate the FD&C Act.
FDA has a variety of enforcement tools, and compliance is the only solution—the question is simply when and how much.
“FDA has sent warning letters in the past to companies illegally selling CBD products that claimed to prevent, diagnose, treat, or cure serious diseases, such as cancer. Some of these products were in further violation of the FD&C Act because the products were marketed as dietary supplements or because the products involved the addition of CBD to food.”
FDA enforcement action, including warning letters, is based on many factors such as the danger to the public health and the current FDA resources. FDA officials will normally consult with federal and state partners before deciding to start a federal enforcement action.
Does FDA object to the clinical investigation of cannabis for medical use?
FDA states that it encourages valid scientific research performed under an IND application for cannabis derived products that may develop into drugs which would have helpful benefits for patients.
Possible ways patients can obtain access to cannabis derived products for medical use – and ways manufacturers can assist these patients
For now, patients may be able to obtain access to cannabis or cannabis-derived products for medical use through expanded access?
Expanded access also may be a possibility for patients who have a life-threatening disease or a serious health condition – to “try an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when there are no comparable or satisfactory therapies available.”
Manufacturers may be able to use FDA’s expanded access protocols to help make these drugs available.
There is also a Right to Try program to help “facilitate access to certain investigational drugs through direct interactions between patients, the patients’ physicians and drug sponsors.” FDA is not involved in these decisions. Sponsors who wish to develop drugs (including CBD products) for life-threatening patient conditions need to determine whether to make the products “available to patients who qualify for access under RTT.”
FDA oversight over foods, drugs, cosmetics, and dietary supplements that have cannabis-based ingredients is evolving. So far, only three drugs have been approved for development and use. In most other areas, FDA approval has not been authorized unless certain exceptions apply or the products are properly categorized under an approved classification – subject to that classification’s other FDA requirements. Instead, FDA warning letters have become a norm.
Contact Cohen Healthcare Law Group, PC to learn how the production, distribution, and sale of cannabis products is regulated by FDA. While some limited exceptions may apply, most cannabis products that are developed or sold through interstate commerce (which includes the vast majority of manufacturers and other cannabis companies) and thus fall within FDA jurisdiction.
Contact our healthcare law and FDA attorneys for legal advice relevant to your healthcare venture.
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