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The Claim Game: FDA Monitoring & Challenging Health Claims for Cannabis Products

There is increasing recognition of the healing potential of cannabis. Even the FDA has approved two synthetic marijuana-based medicines for treatment of nausea in chemotherapy patients and to increase appetite in AIDS patients suffering extreme weight loss.

However, since the FDA’s approval of new drugs relies on testing and clinical trials, the status of cannabis as a Schedule I controlled substance thwarts a progressive scientific environment that enables research into the plant’s effects on a myriad of diseases and symptoms, including cancer, multiple sclerosis, chronic pain, arthritis, gastro-intestinal disorders, movement disorders, HIV/AIDS, and conditions related to aging. Unable to obtain comprehensive scientific proof, patients seeking non-traditional, non-pharma treatment of diseases and symptoms rely largely on anecdotal and testimonial statements from others experiencing their same condition.

Until the FDA formally recognizes cannabis’s healing properties, manufacturers of cannabis products must take great care in making health claims. Earlier in October 2017, the U.S. Food and Drug Administration (FDA) Commissioner suggested that the FDA may begin “cracking down” on health claims for marijuana products. The FDA recognizes that it bears a responsibility to start addressing this issue, citing as an a example arguably problematic unsubstantiated “claims that marijuana has antitumor effects in the setting of cancer.”

But, the FDA is no stranger to cannabis products. In 2015 and 2016, it sent a slew of warning letters to companies making claims about the health benefits of cannabidiol (CBD), such as “strengthens immune system,” “Will alleviate all kinds of anxiety and inflammation problems,” and “CBD kills breast cancer.” In keeping with the FDA’s broad powers, beware that after sending a warning letter, the FDA can institute formal legal proceedings, with successful enforcement resulting in seizure of the offending products.

To date, the FDA has not actively challenged state-legal cannabis products associated with medical claims about the benefits of THC.

Disease Claims

In general, the scope of FDA’s authority is very broad and it regulates food (including dietary supplements), drugs (prescription & non-prescription), tobacco products, and a wide range of other consumer goods. The FDA categorizes products as either a food or drug based on how it is labeled and marketed. In most cases, general statements about health promotion and disease prevention are acceptable, if the claim does not imply that the product can diagnose, cure, mitigate, treat, or prevent a disease.

Caution: A claim that a product is a substitute for a drug or therapy for a disease, or has fewer side effects than traditional remedies, is an implied disease claim. For example, a claim that a product will combat the adverse effects of a therapy, such as chemotherapy in cancer treatment, is considered an implied disease claim.

If the labeling or marketing of a product bears a disease claim (i.e., suggests that the product is intended to diagnose, cure, mitigate, treat, or prevent a disease or a known symptom of a disease), the FDA will classify such a product as a drug, and the product would be subject to strict regulations requiring extensive clinical trials to obtain FDA approval. For example, a statement would be a disease claim if it mentions any specific disease or class of diseases, e.g., “reduces pain associated with arthritis” or “protects against cancer.” Further, claims that address effects that are characteristic symptoms of a disease, e.g., “inhibits tumors,” are considered disease claims, because tumors are a characteristic symptom of cancer.

Please note that including a disclaimer that the statements are not intended to prevent, treat, or cure a disease, or that the statements are not approved by the FDA does not negate the existence of the claims.

Structure/Function Claims

The FDA permits “structure/function” claims, i.e., statements that describe the effect a product may have on the normal composition or role of the body, in connection with foods and dietary supplements without obtaining FDA pre-approval.

Symptoms associated with a wide range of diseases that do not necessarily imply an effect on a specific disease may be considered appropriate structure/function claims. For example, while “relieves stress and frustration” could imply treatment of an anxiety disorder, both these signs (stress and frustration) are also characteristics of non-disease states. When evaluating whether a health claim on product packaging, advertising, promotion on your website may be a disease or structure/function claim, it is essential to consider the context of the claims.

The FDA requirements for structure/function claims are:

(1) There must be a substantiation that the claims are truthful and not misleading;

NOTE: The FDA generally applies a standard of “competent and reliable scientific evidence” to claims about the benefits of dietary supplements. Therefore, anecdotal tests or consumer testimonials are not considered the type of scientific evidence acceptable to the FDA. For further information on clinical research on cannabis, cannabinoids, etc., see Americans for Safe Access Medical Cannabis Research database.

(2) The FDA must be notified within 30 days of first marketing a product that you are using a claim; and

(3) The claim must include the following mandatory disclaimer: These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

Thus, the key to complying with the FDA is determining what is and is not a disease claim, structure/function claim, or no claim at all—which is extremely challenging as there is no exact formula.

Below are examples:

Disease Claims:
Protective against the development of cancer
Reduces the pain and stiffness associated with arthritis
Treats severe depression associated with the menstrual cycle 
Promotes good health and prevents the onset of disease
Alleviates anxiety
Strengthens the immune system

 

Structure/Function Claims:
Improves absentmindedness
Mild mood changes, cramps, and edema associate with menstrual cycle
Relieves stress and frustration
Mild memory loss associated with aging 
Diuretic that relieves temporary water-weight gain

 

No claim at all:
A good diet promotes good health and prevents the onset of disease
Better dietary and exercise patterns can contribute to disease prevention and better health

 

When developing language and copy for your marketing materials, including product packaging, advertising, promotion, press releases, and your website, consider whether the language you propose may subject you to scrutiny by the FDA. Please contact us for assistance in language compliance. As discussed above, in order to make disease or structure/function claims, you would have to meet the rigorous requirements set by the FDA. While you may make general statements about promoting good health and disease prevention, any statements cannot imply that your product can treat, diagnose, prevent, or cure a disease.

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