A Guide To Supplement Claims: What is legal to state and what is not.

Cannabis unarguably has a long range of health benefits.  It's how we market those benefits that will ultimately determine our relationship with the federal government - and the protection of our consumers.

In response to recent warning letters issued by the FDA to cannabis companies for misleading advertising, here are some helpful hints on how to walk the labeling line.

Recently, several cannabis companies have been issued warning letters from the FDA for marketing drug claims on labels and/or media outlets.  

Before we get too far into this, it’s important to know a little background. More than 20 years, the United States Government passed the the Dietary Supplement Health and Education Act (DSHEA) following pressure by supplement companies who were facing arduous hurdles presented by the FDA.

DSHEA striped the FDA’s power to regulate supplement claims by classifying dietary supplements as nutritional foods instead of drugs.  This meant supplement ingredients wouldn’t need to be checked for safety and efficiency before they are released to the market, instead the FDA is the responsible for determining when supplements may be destructive for human health.

The FDA is responsible to ensure that drugs are marketed only for cures and indications which have been proven by medical science – thus ensuring consumers are well-informed and not misled.  Marketing does not mean only what is printed on labels.  The FDA considers any testimonials, social media posts, website content, and other promotional materials as equal to labeling. 

The industry has found ways to market dietary supplements while still meeting FDA regulations.  Here are some instances:

-A supplement can bear the statement “helps promote a better mood” but can’t state that it “treats or reduces depression symptoms”

-It can also bear the statement “helps support cardiovascular function”  but not “prevents cardiovascular disease”.

-It can also make claims like “helps support the immune function” but not “stops or prevents from cold and flu”

There is a very thin line separating disease claims and health function claims that even professionals can’t all agree upon.  For ages, FDA has tried to separate any explicit “medical” or “disease claims” from functional/format claims and/or “health maintenance claims” which are broadly unmonitored. It is extremely hard for the average consumer to spot the differences among logical and allowed claims and exaggerated or unrealistic ones--or even be able to check for false claims and marketing.

Disorder Claims

Disorder claims concentrate on the prevention, treatment, diagnosis, or even cure of a disorder and its symptoms. Some instances are: prevents bad cholesterol, “prevents or lowers the risk of cancer”,

“prevents bone problems”, “treats bloating/constipation”, etc. These types of statements require an FDA evaluation of their efficiency first which features “significant scientific agreement”. However, there are a few statements that already fulfilled FDA guidelines of efficiency and these are among others that “calcium may prevent osteoporosis” and that “folic acid may prevent help defects”.

Now, the matter is even “indirect” supplement claims also require the evaluation and acceptance of FDA. Examples of such statements would be “boosts urinary tract health”, “improves joint recovery and mobility”, “helps maintain healthy gut microflora”, or “reduces joint and muscle strain and inflammation”. Supplement producers are rejecting that these are medical statements/claims and often stretch their claims to the maximum permitted by law.

Structure/Function & Health Maintenance Claims

These feature statements such as “helps maintain cardiovascular function” as well as statements related to different life stages e.g pregnancy, childhood, menopause, and aging.

Other non-medical claims are “boosts energy or stamina”, “improves sexual desire/libido” and “enhances muscle mass”. None of these ambiguous statements require FDA’s acceptance but the supplement label must bear a warning/statement in printed wording that “the statement has not been evaluated by the FDA and the product is not intended to diagnose, cure, or prevent any disease”. Now the problem is, this disclaimer is printed in very small lettering and the consumer may spot only the word FDA and instantly assume wrongly that this indicates FDA’s acceptance.

Although it may be “common knowledge” that vitamin C can “cure a cold”, it can’t be marketed as such.  In the same way, although it may be “common knowledge” (or even scientifically studied) that cannabis can “cure insomnia”, it can’t be marketed as such.

No one, even the FDA, is trying to make the point that cannabis does not have health benefits.  What the FDA is preventing is audacious claims which confuse consumers and create the wrong avenue for advertising markets. 

Instead of marketing cannabis to cure diseases, cannabis companies should focus on a professional yet controlled approach which follows the guidelines of dietary supplement labeling.  This will yield positive responses from the federal government while still helping consumers make informed choices concerning cannabis product effects.