FDA Makes New Statement

Unfortunately, this long-awaited update from the FDA was not what enthusiasts were wanting or expected. In an update on November 25ththe FDA made the warning that CBD poses “real risks” and anyone actively using or considering using CBD should consider those risks.
Trista Best
Written by Trista Best, Registered Dietitian
Last Updated
FDA

CBD, the rapidly growing plant compound known as cannabidiol, is sourced from the cannabis plant and is being extracted and used in a variety of products from edibles to topicals and even pet products. While it is derived from cannabis, it should not be confused with marijuana or THC, tetrahydrocannabidiol.

The cannabis plant used for CBD products is industrial hemp which is grow with 0.3 percent THC or less. THC is the psychoactive compound found in cannabis known to produce the high associated with marijuana, of the same classification of cannabidiol but with quite different effects.

The industry is growing so rapidly that regulatory agencies have not been able to keep up with providing guidance. This poses risks to both the industry leaders and consumers.

The Food and Drug Administration (FDA) finally breaks their silence in light of the US Department of Agriculture’s (USDA) statement regarding CBD and industrial hemp. Supporters from the seasoned CBD user to the leading government officials, have called for guidance and regulations for cannabidiol for quite a while.

The FDA pointed out three specific areas of consideration:

  1. CBD has the potential to harm you, and harm can happen even before you become aware of it.
  2. CBD can cause side effects that you might notice. These side effects should improve when CBD is stopped or when the amount ingested is reduced.
  3. There are many important aspects about CBD that we just don’t know…

These warnings are perfectly acceptable and are certainly worth considering. The concerning aspect of this warning is that it comes with no further guidance from the agency. While there do exist some CBD product companies that are operating out of line with safety and quality standards the reputable companies are practically begging for guidelines.

The reality is CBD exists as a substance available to the general public and it doesn’t appear to be going anywhere. Therefore, the primary governing agency on food and drugs has an opportunity, and some would say the responsibility, to provide some science-based guidelines.

What Are They Wanting?

The industry is asking for two primary interventions from the FDA; guidance on therapeutic dosages and quality/safety standards.

At this point the rapidly growing CBD market companies are making blanketed statements regarding how their products can treat certain conditions or provide specific outcomes. They are determining doses needed for these results on their own and some are breaking current FDA rules regarding marketing their products for therapeutic use in general.

The FDA stepping in with research-based results regarding potential therapeutic benefits and adequate doses to accomplish those would give manufacturers standards and accountability.

Providing safety and quality guidelines is a significant need within the CBD market. At this point the reputable manufacturers are having their products third party lab tested for quality and safety. These tests are looking at potential contaminants, like pesticides, as well as actual cannabidiol quantity and presence of THC.

The way the market is set up at this point in the CBD industry there is no accountability for manufacturers to place the amount of CBD they state they are placing in their products. There is also no accountability that the products contain the 0.3 percent THC or less allowed. As for contaminants, this is lowest on non-reputable suppliers priorities.

With the FDA’s direction the industry could have standards and procedures all cannabidiol products should be placed under. This requested guideline would benefit both the manufacturers and the consumers as they become more confident in the product they are consuming and non-reputable suppliers would eventually fade.

What’s Next?

At this point the FDA has only approved one cannabidiol-based drug, Epidolex, to treat two rare forms of epilepsy. The FDA ends its consumer warning by reinforcing the fact that marketing CBD as a food additive or dietary supplement is illegal. They warn consumers to speak with their physicians prior to implementing the compound into their heath regimen.

This recent statement comes on the heels of the FDA sending 15 CBD companies warning letters. These companies are allegedly violating the FDA’s regulations for marketing products as treatments or therapeutic options for illnesses or conditions. Other violations include making dietary supplement claims and/or adding the compound to food.

This statement from the FDA almost feels like a step backwards in the future of CBD regulation. Consumers should continue to consult their healthcare providers before using any CBD products and should educate themselves on reputable suppliers.

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Trista Best
Trista Best
Registered Dietitian
Trista Best is a Registered Dietitian, Public Health Dietitian, and former college Nutrition Professor. She completed her Bachelor of Science in Health Science from Armstrong Atlantic State University in 2009, Masters of Public Health Nutrition from Liberty University in 2014, and Bachelors of Science in Food and Environmental Sciences from the University of Alabama in 2018. Her dietetic background is in Public Health, Medical Grade Supplements, and Childhood Nutrition.

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