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FDA Stance on the Growing CBD Industry

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As you walk into just about any wellness store or browse online for pain remedies, you’re likely to notice CBD starting to sneak its way into inventory.  The anti-inflammatory properties of this CBD, or cannabidiol, are a tempting natural way to relieve pain.

This can be a seemingly win-win situation for those who don’t tolerate pain medicine and need to manage pain. However, there is a lot of controversy surrounding this compound in the federal arena.

If you watched the news recently, you may have heard about the smokable hemp debacle in the North Carolina government. North Carolina, as well as states like Indiana, think that the government should ban smokable hemp because of its similarity to marijuana (1).

Smokable hemp though, unlike marijuana, contains less than 0.3% delta-9 tetrahydrocannabinol (THC), which is marijuana’s active ingredient (2). The active ingredient in smokable hemp is CBD.

CBD is not known to be psychoactive, but there are so many unknowns with CBD that some say it’s hard to know if it’s safe enough to legalize or not. Therefore, as of July 26, 2019, the North Carolina government has decided to delay the ban until December 2020 in hopes that more research will distinguish the two compounds from one another.

The Hemp Farming Act of 2018 is the federal government stance on CBD thus far (3).

It legalizes industrial hemp that is high in CBD. However, does that mean the Food and Drug Administration (FDA) feels this way about recreational CBD?

Read below to learn more about CBD and the stance of the FDA on this controversial compound.

What is CBD?

CBD is one of the many compounds found in the cannabis plant (4). It’s not known to cause a high like THC, and unlike THC, CBD doesn’t impair judgment.

CBD is an ingredient added to many products recently like pain reliever ointments, smoothies, coffee drinks, and in bath products (5).

Experts suggest that it works in the body by attaching to certain receptors. These receptors are cannabinoid receptors found naturally in the body since the human body produces its own cannabinoids.

These receptors are known as CB1 and CB2 (4). Many CB1 receptors are in the brain, while CB2 receptors are in the immune system.

Even though CBD comes from the same plant as THC, they act differently in the body (5). This is because THC attaches to CB1 receptors, while CBD doesn’t attach to either of these receptors, but instead directs the body to produce more of its own cannabinoids (4).

What is CBD used for?

Besides through hemp, you can also find CBD in the form of CBD oil which has a variety of therapeutic uses.

As of June 2018, the FDA approved the prescription use of Epidiolex, which is a purified form of CBD oil for treating two types of the seizure disorder epilepsy (4,5).

Furthermore, research shows that CBD may help suppress inflammation and neuropathic pain, help cigarette smokers quit smoking, and after further study, may prove to be an effective treatment for certain mental health disorders like schizophrenia (6,7,8).

Experts report that CBD exhibits no evidence of abuse or dependence potential (5).

However, besides the purified CBD oil approved, there are no other known CBD-based medications approved by the FDA (4).

What Does the FDA Think of CBD?

To have an idea of what the FDA thinks of CBD, let’s go back to December 20, 2018. It was on this date that the Agriculture Improvement Act of 2018 became law (9).

Among other things, this law removed hemp from the Controlled Substances Act, in turn no longer making it illegal. This law did, though, preserve the regulation of cannabis and cannabis-derived products just like other products under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and section 351 of the Public Health Service Act.

This regulation means that “selling unapproved products with unsubstantiated therapeutic claims is not only a violation of the law but can put patients at risk (10).”

Any product with a claim of any sort needs to have evidence of its claim and approval by the FDA before it’s approved for sale.

And in April 2019, a statement release noted that a public hearing in May 2019 would address any questions that others had about the recent law on hemp and related cannabis and cannabis-derived products (11).

This report states that the point of the public hearing was to seek “comments, data, and information on…what levels of cannabis and cannabis-derived compounds cause safety concerns” among other safety issues.

Another report released in April 2019 answered some common questions about cannabis and cannabis-derived products. As far as legality is concerned, there were a few questions including (10):

  • Has FDA approved any medical products containing cannabis or cannabis-derived compounds such as CBD?
  • Aside from Epidiolex, are there other CBD drug products that are FDA-approved? What about the products I’ve seen in stores or online?
  • What is FDA’s position on cannabis and cannabis-derived ingredients in cosmetics?

In general, the answers to these questions are that yes, there are other products on the market that contain cannabis or cannabis-derived products. Besides Epidiolex, which is the only drug with approval that contains CBD, there are Marinol and Syndros.

These drugs contain a synthetic form of THC that helps to treat anorexia in patients at risk for weight loss like those with HIV/AIDS.

As far as foods are concerned, foods cannot be for sale via interstate commerce that contain THC or CBD. However, hulled hemp seed, hemp seed protein powder, and hemp seed oil are generally recognized as safe (GRAS) by the FDA.

Finally, as far as cosmetics are concerned, premarket approval is not needed for such products that contain FDA, but the FDA can take action if adverse effects of a products are reported.

What Is the Most Current FDA Stance on CBD?

According to a July 17, 2019 release by the FDA, it explains how it works to protect and promote public health through its current stance on CBD (12).

It basically says that it will regulate any therapeutic applications of CBD and will prohibit sale of CBD in food.

However, it does realize that the public is interested in selling some dietary supplements and products containing CBD. Therefore, it will make exceptions in some cases since some stakeholders are asking for a regulation to “allow for the marketing of CBD in conventional foods or as a dietary supplement or both.”

The FDA states that there are many unanswered questions that need clarity before CBD can be available more widely such as:

  • How much CBD is safe to consume in a day? How does it vary depending on what form it’s taken?
  • Are there drug interactions that need to be monitored?
  • What are the impacts to special populations, like children, the elderly, and pregnant or lactating women?
  • What are the risks of long-term exposure?

Overall, this latest statement from the FDA wants the public to know that it will continue to regulate products made from CBD and derived products. But at the same time, they support and encourage further research so that findings from such studies can speed the development of new therapeutic drugs from such substances.

Takeaway

With so much controversy in the airwaves regarding CBD and hemp recently, it can be hard to keep track of everybody’s stance. And with so many wordy memos and reports, you may not be sure what the stance is of the FDA, which regulates many products that we consume.

But when you break it down, it’s simple to understand.

Although the FDA recognizes that there are potential benefits using CBD for certain conditions, research is still in its early stages. Therefore, to make sure the compound isn’t in a product in a way which is harmful to the consumer, it must have regulations.

This means just like other foods, drugs, and cosmetics, CBD-based products must have approval by the FDA before they receive approval for sale to the consumer.

Overall, the FDA wants to ensure that there is sound science-based evidence for CBD-based product claims before they get into consumer hands. Although this can be frustrating for some that hope to benefit from the potential health benefits of CBD, these regulations are for the safety of the public.

So, until there is more evidence that CBD is safe in certain forms, you can do your part by supporting research foundations for CBD and in time we can all reap the benefits of this calming compound.

Read Next: FDA’s New Efforts to Strengthen Regulation of Dietary Supplements

References
  1. Associated Press (July 4, 2019) “North Carolina proposes ban on smokable hemp.” https://nypost.com/2019/07/04/north-carolina-proposes-ban-on-smokable-hemp/
  2. Hemp Industry Daily (July 26, 2019) “North Carolina lawmakers vote to delay smokable hemp ban.” https://hempindustrydaily.com/north-carolina-lawmakers-vote-to-delay-smokable-hemp-ban/
  3. gov (2017-2018) ”H.R. 5485- Hemp Farming Act of 2018.” https://www.congress.gov/bill/115th-congress/house-bill/5485
  4. Johnson, J. (last updated July 27, 2018) “Everything you need to know about CBD oil.” Medical News Today, https://www.medicalnewstoday.com/articles/317221.php
  5. Grinspoon, M.D., P. (last updated June 5, 2019) “Cannabidiol (CBD) – what we know and what we don’t.” Harvard Health Publishing Harvard Medical School, https://www.health.harvard.edu/blog/cannabidiol-cbd-what-we-know-and-what-we-dont-2018082414476
  6. Xiong W, Cui T, Cheng K, Yang F, Chen SR, Willenbring D, Guan Y, Pan HL, Ren K, Xu Y, Zhang L. Cannabinoids suppress inflammatory and neuropathic pain by targeting α3 glycine receptors. J Exp Med. 2012 Jun 4;209(6):1121-34. doi: 10.1084/jem.20120242. Epub 2012 May 14. PubMed PMID: 22585736; PubMed Central PMCID: PMC3371734.
  7. Morgan, C.J.A., Das, R.K., Joye, A., Curran, H.V., and Kamboj, S.K. (September 2013) “Cannabidiol reduces cigarette consumption in tobacco smokers: Preliminary findings.” Addictive behaviors, 38(9): 2433-2436.
  8. Zuardi, A.W., et al. (2012) “A critical review of the antipsychotic effects of cannabidiol: 30 years of a translational investigation.” Current pharmaceutical design, 18(32): 5131-5140.
  9. Commissioner of Food and Drugs- Food and Drug Administration Scott Gottlieb M.D. (December 20, 2018) “Statement from FDA Commissioner Scott Gottlieb, M.D., on signing of the Agriculture Improvement Act and the agency’s regulation of products containing cannabis and cannabis-derived compounds.” https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-signing-agriculture-improvement-act-and-agencys
  10. S. Food and Drug Administration (April 2, 2019) “FDA Regulation of Cannabis and Cannabis-Derived Products: Questions and Answers.” https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-questions-and-answers
  11. Commissioner of Food and Drugs- Food and Drug Administration Scott Gottlieb M.D. (April 2, 2019) “Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to advance agency’s continued evaluation of potential regulatory pathways for cannabis-containing and cannabis-derived products.” https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-new-steps-advance-agencys-continued-evaluation
  12. Amy Abernethy, M.D., Ph.D., Principal Deputy Commissioner, and Lowell Schiller, J.D., Principal Associate Commissioner for Policy (July 17, 2019) “FDA is Committed to Sound, Science-based Policy on CBD.” https://www.fda.gov/news-events/fda-voices-perspectives-fda-leadership-and-experts/fda-committed-sound-science-based-policy-cbd

Stock Photos from JETACOM AUTOFOCUS / Shutterstock

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