FDA Warns Companies to Stop Making False Claims for THC and CBD Products

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FDA Warns Companies to Stop Making False Claims for THC and CBD Products


  • The FDA is warning companies for using false claims for their THC and CBD products.
  • The companies allegedly claimed that THC and CBD products could cure or alleviate certain health conditions.
  • People with heart conditions should not use THC products, according to experts.

The Food and Drug Administration (FDA) has issued a warning to five companies that have been illegally selling THC and CBD products, falsely claiming they can diagnose, cure, prevent, alleviate or treat various health conditions.

According to the FDA’s warning, the companies have been selling products with delta-8 THC — a compound that has psychoactive and intoxicating effects. There are currently no FDA-approved drugs that contain delta-8 THC.

Most THC and CBD products are unregulated and are therefore not able to assert health claims since the FDA has not evaluated the safety, side effects, and quality of many CBD and THC products.

Health experts recommend consulting a healthcare provider and using CBD and THC products with caution.

“It’s a jungle out there. Most internet sources and budtenders are of no help – remember, they have no formal training, and their job is to sell, not to give advice,” Dr. Daniele Piomelli, director of the UCI Center for the Study of Cannabis, told Healthline.

“For now, there isn’t much beyond the old trial and error,” Piomelli added.

The products flagged by the FDA contain delta-8 THC rather than delta-9 THC. THC is typically the psychoactive compound in cannabis products.

According to Dr. Kelly Johnson-Arbor, a medical toxicologist and co-medical director of the National Capital Poison Center, delta-8 THC has a very similar chemical structure to delta-9 THC but is less potent.

Delta-8 TCH is present in low amounts in cannabis plants, and these products can be manufactured from CBD. Higher amounts of delta-8 THC are needed to achieve the same clinical effects as delta-9 THC.

The delta-8 THC products on the market are synthetic, says Dr. Yalda Shokoohinia, a principal scientist at Ric Scalzo Institute for Botanical Research at the Southwest College of Naturopathic Medicine.

“The dosing, clinical effects, and safety of delta-8 THC have not been studied extensively in humans, and it is unclear what a ‘standard’ dose of delta-8 THC represents,” says Johnson-Arbor.

According to Johnson-Arbor, the standard dose of CBD is not well understood, and there is limited evidence on the compound’s ability to treat or prevent diseases.

Piomelli says that, with very few exceptions, the positive health effects of THC and CBD have not been backed by sufficient data.

For THC, the exceptions include nausea and treatment of chronic pain as there is substantial, though inconclusive, evidence that THC can help with these issues.

The exception for CBD is that it can help with seizure disorders, according to Piomelli.

Epidiolex, a prescription drug that helps treat two types of rare seizure disorders, is the only CBD product approved by the FDA.

“Other claims are often based on small clinical studies or animal experiments, which are not sufficient to make a recommendation,” Piomelli said.

According to Shokoohinia, though some studies have shown beneficial health effects of cannabis and hemp products, companies cannot claim that these products can treat or prevent health conditions since they aren’t regulated by the FDA.

More clinical and toxicity studies are needed before these products can get approved.

“Herbal / botanical products are useful remedies for health support, but like chemical drugs, they also can have adverse effects, contraindications, and toxicity,” Shokoohinia said.

In high doses, CBD can cause liver injury and may potentially contribute to male infertility and decreased alertness, according to Shokoohinia.

Piomelli says self medicating is always risky.

He recommends talking with a doctor who can provide recommendations on using cannabis products.

At the very least, he recommends practicing caution when using cannabis products for health conditions.

“Start with a low dose, go up slowly, monitor yourself,” Piomelli said.

According to Piomelli, people with heart conditions should not use THC, and those on blood pressure or heart drugs should avoid high doses of CBD.

Teenagers should avoid frequent or high doses of THC, Piomelli added. The FDA recommends pregnant people or those breastfeeding should avoid cannabis altogether.

Shokoohinia recommends looking for products with informative labels about the quantity of the compounds.

“For CBD oil labels, look for mg/mL to determine concentration; for gummies, ensure that you read the serving to know the concentration in each gummy and not just in the entire container,” Shokoohinia said.

Shokoohinia also recommends looking for a third-party testing certificate of analysis, which may show how much CBD or THC is in the product and if it’s been tested for contaminants, pesticides, heavy metals, and mold.

The FDA has issued a warning to five companies that have been illegally selling THC and CBD products, falsely claiming they can diagnose, cure, prevent, alleviate or treat various health conditions. Most THC and CBD products are unregulated and are therefore not able to assert health claims since the FDA has not evaluated the safety, side effects, and quality of many CBD and THC products. Health experts recommend talking with a physician and practicing caution when using cannabis products to treat health conditions.



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