Cannabis Medical Claims Guide

Claims that imply medical benefits or therapeutic effects are prohibited in product labeling, online marketing, advertising, booth displays, etc.

This document offers a general framework for crafting substantiated claims for product labeling and marketing of cannabis products within publications.

It’s important to remember that this framework is not all-inclusive and may not address every possible scenario.

Cannabis Health Claims: An Advanced Guide

Understanding FDA & FTC Regulations For Cannabis Products

This comprehensive guide offers a deep dive into the complex world of health claims for cannabis products, providing essential insights for businesses and marketers alike. It navigates through the regulatory landscape set by the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC), shedding light on what you can and cannot say about your cannabis products.

Key Takeaways:

  • The Importance of Accurate Health Claims: Misleading or unsubstantiated health claims can lead to severe legal consequences, including fines, product recalls, and damage to your brand’s reputation.
  • FDA and FTC Regulations: Understand the specific guidelines set by these regulatory bodies for health claims related to cannabis products.
  • Differentiating Drugs and Supplements: Clearly distinguish between cannabis products that qualify as drugs and those that are considered dietary supplements, as their regulatory requirements differ significantly.
  • Permissible Claims: Learn about the types of claims that are allowed for cannabis products, such as structure-function claims, and how to make them effectively.
  • Avoiding Prohibited Claims: Understand the specific health claims that are prohibited for cannabis products to avoid legal pitfalls.
  • Scientific Substantiation: Learn the importance of having strong scientific evidence to support any health claims you make about your cannabis products.
  • Compliance Strategies: Discover practical strategies to ensure your marketing materials and advertising campaigns comply with FDA and FTC regulations.

This guide covers a wide range of topics, including:

  • FDA and FTC regulations
  • Permissible and prohibited health claims
  • Scientific substantiation
  • Compliance strategies
  • Case studies and lessons learned
  • International regulations
  • Emerging trends and technologies
  • Consumer education
  • Checklists for health claim compliance

By understanding and adhering to these regulations, you can effectively market your cannabis products while protecting your business from legal risks and maintaining consumer trust.

UNACCEPTABLE CANNABIS PRODUCT DISEASE OR DRUG-LIKE CLAIMS

Terms like “prevent,” “treat,” “cure,” “chronic,” “control,” “increase,” “lower,” “manage,” “reduce,” and “regulate” should not be used in relation to the following conditions or symptoms.

Medical Conditions and Symptoms

  • Arthritis: Osteoarthritis, Rheumatism, Pain
  • Cancer: Anti-Cancer, Anti-Carcinogen, Anti-Tumor
  • Cardiovascular disease (CVD): heart attack, stroke, atherosclerosis, hypertension, hypercholesterolemia, blood pressure, cholesterol
  • Diabetes: Anti-diabetes, impact on blood sugar management, glucose control, metabolic syndrome
  • Digestive Disorders: Digestive/gastro-intestinal disorders, ulcers, colitis, acid reflux, GERD, gastritis, IBS, leaky gut
  • Eye Diseases: Age-related macular degeneration (AMD), glaucoma, cataracts, blindness, eye disorders
  • Infections: Antibiotic, antibacterial, antiviral, antifungal, infection, cold/flu, fever
  • Obesity and Metabolism: Anti-obesity, reduce obesity, diabetes, anti-diabetes, metabolic syndrome
  • Neurodegenerative Disorders: Neurodegenerative disorders, Parkinson’s, MS
  • Neurological Conditions: ADHD, Alzheimer’s disease, dementia
  • Pain and Inflammation: Pain, inflammation due to any disease or symptom of disease
  • Reproductive Health: Erectile dysfunction, impotence, BPH, endometriosis, infertility
  • Hangover
  • Respiratory Conditions: Allergies, asthma, bronchitis, COPD, respiratory/sinus infections
  • Sleep Disorders: Insomnia, sleep disorders
  • Urinary Tract Issues: Urinary tract infection (UTI), cystitis

Cosmetic Or Topical Product Claims To Avoid

  • Medical Benefits: Pain, skin disorders/lesions, dandruff, eczema, psoriasis, heals wounds, rosacea, cystic/severe acne, repair UV damage
  • Systemic Effects: Transdermal, improves blood circulation, increases nutrient absorption into the skin that affects structure or function within the body

Note: This list is not exhaustive, and specific regulations may vary depending on jurisdiction. It’s essential to consult with legal and regulatory experts to ensure compliance with local guidelines.

According to U.S. law (21 USC § 321(g)(1), products making claims about the diseases listed above may be categorized as drugs.

(g)(1) The term “drug” means (A) articles recognized in the official United States Pharmacopoeia,1 official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C). A food or dietary supplement for which a claim, subject to sections 343(r)(1)(B) and 343(r)(3) of this title or sections 343(r)(1)(B) and 343(r)(5)(D) of this title, is made in accordance with the requirements of section 343(r) of this title is not a drug solely because the label or the labeling contains such a claim. A food, dietary ingredient, or dietary supplement for which a truthful and not misleading statement is made in accordance with section 343(r)(6) of this title is not a drug under clause (C) solely because the label or the labeling contains such a statement.

ACCEPTABLE CANNABIS PRODUCT CLAIMS

The following terms may be used to emphasize a healthy state: supports, promotes, maintains, normal, healthy.

General Health Benefits

  • Cardiovascular Health: Heart health, healthy cardiovascular function, arterial function, supports healthy cholesterol levels, maintains normal blood pressure
  • Cellular Health: Immune function, normal cell function
  • Cognitive: Cognitive function, brain development, focus, concentration, mental clarity
  • Digestive Health: Healthy digestion, helps with occasional stomach upset, indigestion, or heartburn, promotes regularity
  • Hydration and Metabolism: Rehydration, metabolism support
  • Immune: Boosts immune function, optimizes immune system
  • Inflammation: Balances inflammation response
  • Joint Health: Joint health, mobility, supports normal joint function
  • Metabolic Health: Healthy blood sugar/glucose, promotes normal insulin function/metabolism
  • Neurological Health: Neurological health, healthy nerve function
  • Reproductive Health: Male/female reproductive health, healthy prostate, healthy libido
  • Respiratory: Seasonal allergy relief, healthy respiratory function
  • Sleep: Restful sleep, occasional restlessness
  • Urinary Tract Health: Urinary tract health
  • Vision: Vision health, normal eye function
  • Weight Management: Supports weight management, promotes weight loss

Cosmetic and Topical Products

  • Skin Benefits: Soothes dry, flaky, irritated skin/scalp, moisturizes, hydrates, cleanses, reduces the appearance of wrinkles/dark circles/scars, minor/mild acne/blemishes
  • Limitations: May address surface effects only, no internal benefits/actions

Note: This list is not exhaustive, and specific regulations may vary depending on jurisdiction. It’s essential to consult with legal and regulatory experts to ensure compliance with local guidelines.

According to 21 USC § 343(r)(6), supplement claims should either explain how an ingredient affects the structure or function of the human body, describe the scientific evidence supporting its mechanism of action, or discuss the overall health benefits associated with consuming the ingredient.

(6) For purposes of paragraph (r)(1)(B), a statement for a dietary supplement may be made if—

(A) the statement claims a benefit related to a classical nutrient deficiency disease and discloses the prevalence of such disease in the United States, describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans, characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function, or describes general well-being from consumption of a nutrient or dietary ingredient,

(B) the manufacturer of the dietary supplement has substantiation that such statement is truthful and not misleading, and

(C) the statement contains, prominently displayed and in boldface type, the following: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”.

A statement under this subparagraph may not claim to diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases. If the manufacturer of a dietary supplement proposes to make a statement described in the first sentence of this subparagraph in the labeling of the dietary supplement, the manufacturer shall notify the Secretary no later than 30 days after the first marketing of the dietary supplement with such statement that such a statement is being made.

Legal Disclaimer

The information provided in this response is for general informational purposes only and does not constitute legal advice. While we strive to provide accurate and up-to-date information, laws and regulations may change over time and can vary based on specific circumstances. It is important to consult with a qualified legal professional or relevant regulatory authority to obtain advice tailored to your specific situation.

The use of this information does not establish an attorney-client relationship between the reader and the author or its agents. The author and its agents do not accept any responsibility or liability for any actions taken or not taken based on the information provided in this manual.

Any references or links to external sources or third-party websites are provided for convenience and do not imply endorsement or approval of the content, products, or services provided by such sources.

The reader assumes all responsibility and risk for the use of the information provided. The author and its agents disclaim any and all liability for any loss or damage incurred as a result of the use or reliance on the information provided in this response.