4 Suggested Solutions

We Believe the Food and Drug Administration Should...

WARN THE PUBLIC OF THE DANGERS OF THE CBD MARKET

1

Untested, unapproved CBD products may pose a growing public health threat. This is a rapidly growing consumer market composed of CBD products that – unlike prescription drugs, over-the-counter medications, cosmetics, or food products – has been operating outside the scope of federal law and regulation. Nearly all of these products:

  1. Have not been scientifically tested for safety and efficacy
     

  2. Have labels that may or may not be accurate in terms of lists of ingredients and potency
     

  3. May include ingredients that have not been verified by reliable third parties for purity and potency
     

  4. Are illegal under the Federal Food, Drug and Cosmetic Act
     

SOLUTION:

The FDA should warn the public about the dangers of unapproved, untested, illegal CBD products.

ENFORCE EXISTING REGULATIONS REGARDING LABELING AND INGREDIENTS

2

Mislabeling is common with CBD products. A study published in the Journal of the American Medical Association found that seven of ten CBD products are inaccurately labeled, carrying either a greater concentration of CBD than indicated on the label or less concentration than the label promises.

Consumers utilizing unapproved CBD products run the risk of encountering harmful contaminants. Independent testing of the 240 top-selling CBD products found that 70 percent were contaminated with substances including lead, arsenic, herbicides, pesticides, and toxic mold. One product had lead levels so high, it was 100 times greater than the Environmental Protection Agency (EPA) threshold for safe drinking water.

 

SOLUTION:

The FDA should curtail the proliferation of potentially dangerous, unapproved CBD products by using its existing legal authority.

DETERMINE SAFE CONCEN-TRATION LEVELS FOR CBD PRODUCTS

3

The idea that unapproved CBD products contain only the “safe” parts of the hemp plant is not always correct. The Center for Science in the Public Interest (CSPI) and the Consumer Federation of America (CFA) recently highlighted a study showing that 18 of 84 CBD product samples tested contained THC levels sufficient to cause impairment. This heightens the risk, particularly for young children and pets. When the THC level is enough to produce intoxication or a positive result on a drug test, which has already led to some consumers unwittingly losing their jobs, it’s clear that we need greater testing and oversight.

Additionally, clinical testing of the sole FDA-approved CBD medication provided scientific data showing that higher levels of CBD can potentially cause liver damage or liver toxicity from cumulative use over time.

SOLUTION:

The FDA should establish a firm, enforceable ceiling on the potency of CBD that can be contained in an individual product and require safe packaging practices similar to the child-proof closures on prescription medicines. All products should include a 1-800 phone number to allow concerned consumers to call the manufacturers to make specific inquiries about the product.

ENCOURAGE ROBUST CLINICAL RESEARCH INTO CBD’S POTENTIAL TO IMPROVE HEALTH AND LIVES

4

It is important to encourage robust clinical research into the potential of CBD so that patients will have more treatment options. The potential health benefits of CBD need to be better understood and optimized, which can only be done through clinical testing with scientifically validated methodologies. The rush of untested products to the marketplace isn’t good for public health and has discouraged legitimate companies from dedicating the time, effort, and resources needed to develop products that could be FDA-approved.

 

SOLUTION:

The FDA should incentivize CBD research, clinical trials, and the creation of new CBD treatments that are backed by science and approved by the FDA. Many people agree CBD has the potential to improve lives, but research and clinical data are needed to move the industry forward in the right direction.

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