FDA declines to regulate CBD; calls on Congress for fix

Jan 25, 2023, 9:08 PM | Updated: Jan 26, 2023, 1:26 pm
FILE - CBD wax is displayed at a shop in Sunset Hills, Mo., on June 27, 2019. The Food and Drug Adm...

FILE - CBD wax is displayed at a shop in Sunset Hills, Mo., on June 27, 2019. The Food and Drug Administration said Thursday, jan. 26, 2023, there are too many unknowns about CBD products to regulate them as foods or supplements under the agency's current structure and Congress needs to create new rules for the massive and growing market. (Brian Munoz/St. Louis Post-Dispatch via AP, File)

(Brian Munoz/St. Louis Post-Dispatch via AP, File)

The Food and Drug Administration said Thursday there are too many unknowns about CBD products to regulate them as foods or supplements under the agency’s current structure and called on Congress to create new rules for the massive and growing market.

The marijuana-derived products have become increasingly popular in lotions, tinctures and foods, while their legal status has been murky in the U.S.

There’s not enough evidence about CBD to confirm that it’s safe for use in foods or as a dietary supplement, FDA Deputy Commissioner Dr. Janet Woodcock said in a statement.

“For example, we have not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm,” she said.

The FDA has oversight of CBD because it is the active ingredient in an approved prescription drug, Epidiolex, used to treat two rare seizure disorders. Under FDA regulations, a drug can’t be added to food or sold as a dietary supplement if officials haven’t determined if it’s safe or effective for other conditions.

Questions remain about CBD’s effects on the liver, the male reproductive system and on pregnant women and children, the statement said.

New rules could include clear labels, regulations regarding contaminants, limits on CBD levels and requirements, such as a minimum purchase age. Regulations are also needed for CBD products for animals, the agency said.

CBD often comes from a cannabis plant known as hemp, which is defined by the U.S. government as having less than 0.3% THC, the compound that causes marijuana’s mind-altering effect. CBD doesn’t cause that high, but fans of the products claim benefits including relief for pain and anxiety.

The FDA’s action comes after repeated calls from lawmakers, advocates and consumer groups for CBD to be allowed in foods and supplements.

The agency also denied three petitions from advocacy groups that had asked the agency to allow products that contain the hemp ingredient to to be marketed as dietary supplements. Steve Mister, chief of the Council for Responsible Nutrition, a trade group for the supplement industry and one of the petitioners, expressed dismay at the denial and said FDA was “kicking the can down the road while ignoring the realities of the marketplace” by referring the issue to Congress.

“FDA has repeatedly disregarded evidence demonstrating safety that is relevant to CBD at the levels commonly used in supplements and continues to rely heavily on safety concerns related to high dosage Epidiolex to support the agency’s inaction,” Mister said in a statement.

The FDA will continue to take action against CBD and other cannabis products to protect the public, Thursday’s statement said. The agency has sent warning letters to some companies making health claims for CBD.

Marijuana itself remains illegal at the federal level in the U.S., although it has been allowed for medical and recreational use in many states, including use in pot-laced food and drinks.

___

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.

Copyright © The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

AP

File - People shop at an Apple store in the Westfield Garden State Plaza mall in Paramus, New Jerse...
Associated Press

A key inflation gauge tracked by the Fed slowed in February

The Federal Reserve's favored inflation gauge slowed sharply last month, an encouraging sign in the Fed's yearlong effort to cool price pressures through steadily higher interest rates.
2 days ago
FILE - The OpenAI logo is seen on a mobile phone in front of a computer screen displaying output fr...
Associated Press

Musk, scientists call for halt to AI race sparked by ChatGPT

Are tech companies moving too fast in rolling out powerful artificial intelligence technology that could one day outsmart humans?
3 days ago
starbucks...
Associated Press

Starbucks leader grilled by Senate over anti-union actions

Longtime Starbucks CEO Howard Schultz faced sharp questioning Wednesday before the Senate Health, Education, Labor and Pensions Committee
4 days ago
FILE - The overdose-reversal drug Narcan is displayed during training for employees of the Public H...
Associated Press

FDA approves over-the-counter Narcan; here’s what it means

The U.S. Food and Drug Administration on Wednesday approved selling naloxone without a prescription, the first over-the-counter opioid treatment.
4 days ago
FILE - A Seattle police officer walks past tents used by people experiencing homelessness, March 11...
Associated Press

Seattle, feds seek to end most oversight of city’s police

  SEATTLE (AP) — The U.S. Justice Department and Seattle officials asked a judge Tuesday to end most federal oversight of the city’s police department, saying its sustained, decade-long reform efforts are a model for other cities whose law enforcement agencies face federal civil rights investigations. Seattle has overhauled virtually all aspects of its police […]
5 days ago
capital gains tax budgets...
Associated Press

Washington moves to end child sex abuse lawsuit time limits

People who were sexually abused as children in Washington state may soon be able to bring lawsuits against the state, schools or other institutions for failing to stop the abuse, no matter when it happened.
5 days ago

Sponsored Articles

Compassion International...

Brock Huard and Friends Rally Around The Fight for First Campaign

Professional athletes are teaming up to prevent infant mortality and empower women at risk in communities facing severe poverty.
Emergency Preparedness...

Prepare for the next disaster at the Emergency Preparedness Conference

Being prepared before the next emergency arrives is key to preserving businesses and organizations of many kinds.
SHIBA volunteer...

Volunteer to help people understand their Medicare options!

If you’re retired or getting ready to retire and looking for new ways to stay active, becoming a SHIBA volunteer could be for you!
safety from crime...

As crime increases, our safety measures must too

It's easy to be accused of fearmongering regarding crime, but Seattle residents might have good reason to be concerned for their safety.
Comcast Ready for Business Fund...
Ilona Lohrey | President and CEO, GSBA

GSBA is closing the disparity gap with Ready for Business Fund

GSBA, Comcast, and other partners are working to address disparities in access to financial resources with the Ready for Business fund.
SHIBA WA...

Medicare open enrollment is here and SHIBA can help!

The SHIBA program – part of the Office of the Insurance Commissioner – is ready to help with your Medicare open enrollment decisions.
FDA declines to regulate CBD; calls on Congress for fix