The Food and Drug Administration (FDA) is currently sending out warning letters to any cannabis company that market unapproved new drugs that allegedly contain cannabidiol (CBD) as well as companies that sell foods and beverages containing CBD. FDA’s mission is to “The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.” The FDA states “Over the past several years, FDA has issued several warning letters to firms that market unapproved new drugs that allegedly contain cannabidiol (CBD). As part of these actions, FDA has tested the chemical content of cannabinoid compounds in some of the products, and many were found to not contain the levels of CBD they claimed to contain. It is important to note that these products are not approved by FDA for the diagnosis, cure, mitigation, treatment, or prevention of any disease. Consumers should beware purchasing and using any such products.”
In addition, the FDA “issued warning letters to five companies for selling products labeled as containing delta-8 tetrahydrocannabinol (delta-8 THC) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). This action is the first time the FDA has issued warning letters for products containing delta-8 THC. Delta-8 THC has psychoactive and intoxicating effects and may be dangerous to consumers. The FDA has received reports of adverse events experienced by patients who have consumed these products.”
What does this mean? Overall, cannabis is cannabis, and understanding the industry’s compliance side means you should have a compliance officer who knows how to handle complex compliance issues when dealing with the FDA. Our team has over a combined 50 years of medical device and pharmaceutical backgrounds, so we are very comfortable dealing with false label claims, recall actions, GMP and SOP issues, management representation, pre-inspection, QA/QC and FDA inspections. Robert Half posted a blog about the role of a compliance officer and it should apply to the cannabis industry as well. In it, it states the following:
Compliance officers assist teams within their company in developing, implementing, maintaining and supporting compliance programs. They also do the following:
- Coordinate, review and update existing accounting policies and procedures
- Manage the ongoing review of materials and communication tools to ensure departments meet compliance requirements
- Adhere to regulatory reporting guidelines and filing deadlines
- Conduct compliance audits and interpret these reports for various departments
- Facilitate remediations of audit findings by training staff to make course corrections and prevent future violations
In the event marijuana is removed from the Schedule I substance under the Controlled Substances Act, there will be a need for a compliance/regulatory worker at every ancillary cannabis businesses including cultivation, nursery, dispensary, laboratory, distribution, transportation and manufacturing. Why? Because like any other industry that creates a product for the public, there will need to be protection for the public. Like the FDA. This is a good thing because the cannabis industry is standardized. The public will demand safety with cannabis products because it is cannabis. A plant that has old stigmas attached nonetheless has a mutual benefit for the consumer. However we do not want cannabis products that contain misleading labels like “THC cures cancer” or “This product cures acne”.
The FDA states just for medical device labeling requirements are as follows:
Section 502 of the Federal Food, Drug and Cosmetic Act (FFDCA) contains provisions on misbranding including some that relate to false or misleading labeling. A device’s labeling misbrands the product if:
- Its labeling is false or misleading in any particular;
- It is in package form and its label fails to contain the name and place of business of the manufacturer, packer, or distributor and an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count;
- Any required wording is not prominently displayed as compared with other wording on the device, or is not clearly stated;
- Its label does not bear adequate directions for use including warnings against use in certain pathological conditions or by children where its use may be dangerous in health or against unsafe dosage, or methods, or duration of administration or application;
- It is dangerous to health when used in the dosage or manner or with the frequency or duration prescribed, recommended or suggested in the labeling; or
- It does not comply with the color additives provisions listed under Section 706 of the FFDCA;
- The device’s established name (if it has one), its name in an official compendium, or any common or usual name is not prominently printed in type at least half as large as that used for any proprietary name;
- The establishment is not registered with FDA as required by Section 510 of the FFDCA and has not listed the device as required by Section 510(j) of the FFDCA or obtained applicable premarket notification clearance as required by Section 510(k) of the FFDCA;
- The device is subject to a performance standard and it does not bear the labeling prescribed in that standard;
- There is a failure or refusal to comply with any requirement related to notification and other remedies prescribed under Section 518 of the FFDCA, if there is a failure to furnish any materials or information required by, or requested by the Secretary pursuant to, Section 519 of the FFDCA, or if there is a failure to furnish materials or information relating to reports and records required by Section 522 of the FFDCA; or
- There is any representation that creates an impression of official approval because of the possession by the firm of an FDA registration number.
Cannabis is not a medical device however the labeling requirements should be regarded as a standard as if treated like one. What about false or misleading labels? FDA states the following:
False or Misleading Labeling
Section 502(a) declares that a drug or device is misbranded if its labeling proves false or misleading in any particular. Section 201(n) states that if an article is alleged to be misbranded because the labeling or advertising is misleading, then in determining whether the labeling or advertising is misleading, there shall be taken into account (among other things) not only representations made or suggested by statement, word, design, device, or any combination thereof, but also the extent to which the labeling or advertising fails to reveal facts material in the light of such representations or material with respect to consequences which may result from the use of the article to which the labeling or advertising relates under the conditions of use prescribed in the labeling or advertising thereof or under such conditions of use as are customary or usual.
The above statement is with respect to medical devices however again the cannabis industry should treat its products like one.
Some good news: There are solutions to cannabis labeling problems. A checklist. The California Department of Public Health has a checklist for labeling requirements for cannabis manufacturing companies. Below are the Do’s and Dont’s of labeling requirements for cannabis requirements.
Display information clearly and legibly
Use English and at least 6 point font
Ensure all required labeling is displayed on the outer layer of packaging
- California county names — Unless 100% of cannabis in the product is grown in the county, the name of a California county cannot be included on the label.
- Cannot be attractive to children — This includes using cartoons, images popularly used to advertise to children, imitating candy labeling, and using the words “candy,” “candies” or a variation, such as “kandy” or “kandeez” anywhere on the label.
- Cannot include false or misleading information — This includes anything untrue or unproven, or information that leads consumers to have an inaccurate impression, or the use of the word “organic” anywhere on the label.
- Cannot make unproven health claims — Health-related statements, such as claims about a product’s ability to treat or cure disease, may not be made unless there is significant scientific agreement and the claims are supported by a totality of publicly-available peer-reviewed evidence. Anecdotal information and preliminary study results do not meet this criteria. Note: Health-related statements are heavily regulated by the FDA, and cannabis businesses are not exempt from federal prosecution for misleading health statements.
- Cannot include a picture of the product (for edible cannabis products only) — State law required edibles to be in opaque packaging to reduce the risk that a child would be attracted to the product. Photographs or other images of the product cannot be on the label for the same reason.
- Cannot market the product as an alcoholic beverage — More information on this label restriction can be found in the Bureau of Cannabis Control regulations §5041.1.