FDA looks into regulating CBD in food, beverages and more

The US Food and Drug Administration announced Tuesday...

Posted: Apr 3, 2019 9:08 AM

The US Food and Drug Administration announced Tuesday that it will hold a public hearing next month to discuss developing a regulatory framework for the use of CBD in consumer products, including foods and beverages.

CBD, the abbreviation for cannabidiol, is one of the non-psychoactive ingredients in cannabis, increasingly thought to offer wide-ranging health benefits, with few side effects and low risk of addiction or abuse. Tetrahydrocannabinol or THC is the main psychoactive component of the cannabis plant.

FDA Commissioner Dr. Scott Gottlieb said in a statement that the move was part of an effort to build "lawful pathways by which appropriate products containing cannabis or cannabis-derived compounds can be marketed" and made "more predictable and efficient."

Gottlieb, who announced last month that he was resigning from his post, also renewed his pledge to crack down on companies promoting "unfounded, egregious claims about their products' ability to limit, treat or cure cancer, neurodegenerative conditions, autoimmune diseases, opioid use disorder, and other serious diseases."

Last month, he said, the FDA sent warning letters to PotNetwork Holdings in Florida, Nutra Pure in Washington state and Advanced Spine and Pain in New Jersey for "making unsubstantiated claims related to more than a dozen different products and spanning multiple product webpages, online stores and social media websites."

It's illegal under the Food Drug & Commerce Act to introduce CBD or THC into the food supply or market it as a dietary supplement, regardless of whether the substances are hemp-derived.

The FDA isn't interested in immediately doing away with that restriction, because both "CBD and THC are active ingredients in FDA-approved drugs and were the subject of substantial clinical investigations before they were marketed as foods or dietary supplements," Gottlieb said in a statement in December.

In Tuesday's statement, Gottlieb warned that "open questions remain regarding the safety" of widespread use of CBD products, including CBD concentration and the possible impacts of long-term exposure.

"It's critical that we address these unanswered questions about CBD and other cannabis and cannabis-derived products to help inform the FDA's regulatory oversight of these products," he said. "Especially as the agency considers whether it could be appropriate to exercise its authority to allow the use of CBD in dietary supplements and other foods."

However, Gottlieb has made clear in the past that foods derived from parts of the hemp plant that may not contain CBD or THC could be marketed with FDA approval. In December, he announced that hulled hemp seeds, hemp seed protein and hemp seed oil could be marketed as long as they made no disease treatment claims.

Legalization of hemp

In December, President Donald Trump signed the Farm Bill into law; among other things, it legalized the production of hemp, which contains high levels of CBD.

Late last year, the FDA approved the first cannabis-based prescription medication, called Epidiolex, to treat epileptic seizures, but Gottlieb recently told the Brookings Institute that legalizing CBD for use in food and dietary products could take several years.

The legal limbo for products being sold with CBD created strain on the industry. In February, a bipartisan group of lawmakers sent a letter to Gottlieb about crackdowns on selling CBD food and beverages by officials in New York City, Ohio and Maine, saying that the actions "spurred a tremendous amount of confusion among product manufacturers, hemp farmers, and consumers of these products. We are calling on FDA to swiftly provide guidance on lawful pathways for food products with CBD."

The public hearing is scheduled for May 31, well after Gottieb will leave office.

In reaction to Gottlieb's announcement Tuesday, Rep. Chellie Pingree said in a statement, "It's clear that Commissioner Gottlieb is prioritizing this issue and taking it seriously. I hope his [successor] at the FDA will operate with the same sense of urgency. After FDA collects input from stakeholders through public comment and at the May 31 public meeting, I will consider any legislative avenues that may be necessary to resolve this issue."

'Industry reaction

Reaction from the industry was positive. "We look forward to the FDA being more open to considering the medical benefits of cannabinoids and examining the research on the subject," said Morgan Fox, director of media relations for the National Cannabis Industry Association.

Erica McBride Stark, executive director for the National Hemp Association, said, "we encourage the FDA to move as quickly as possible to protect the interests of all and welcome the opportunity to bring this important industry out of the shadows. Creating this legal framework will protect both consumers and the industry."

Indiana Coronavirus Cases

Data is updated nightly.

Cases: 751242

Reported Deaths: 13795
CountyCasesDeaths
Marion1032931788
Lake556911009
Allen41692692
St. Joseph36990565
Hamilton36588417
Elkhart29398461
Tippecanoe22901226
Vanderburgh22556400
Porter19356325
Johnson18471389
Hendricks17682317
Clark13226195
Madison13149344
Vigo12614253
LaPorte12419221
Monroe12207176
Delaware10966198
Howard10321225
Kosciusko9630121
Hancock8576146
Bartholomew8169157
Warrick7860156
Floyd7811180
Grant7242179
Wayne7162201
Boone6966103
Morgan6761141
Dubois6218118
Marshall6209116
Cass6016110
Henry5900110
Dearborn589878
Noble581488
Jackson509076
Shelby501496
Lawrence4742122
Gibson444894
Clinton442355
Harrison441875
DeKalb439885
Montgomery438090
Whitley406543
Huntington402681
Steuben400159
Miami395269
Jasper388054
Knox375991
Putnam372960
Wabash361983
Ripley347170
Adams345555
Jefferson335886
White331953
Daviess3033100
Wells295281
Decatur289992
Greene286885
Fayette284864
Posey273835
LaGrange273072
Scott270156
Clay267148
Washington246036
Randolph244783
Jennings235349
Spencer234531
Starke228058
Fountain220948
Sullivan214643
Owen211858
Fulton202942
Jay200932
Carroll193620
Orange188255
Perry187237
Rush175926
Vermillion174844
Franklin170335
Tipton166246
Parke149416
Pike138234
Blackford136232
Pulaski120647
Newton113936
Brown104243
Crawford102516
Benton101714
Martin91715
Warren84015
Switzerland8148
Union72810
Ohio57911
Unassigned0420

Ohio Coronavirus Cases

Data is updated nightly.

Cases: 1108902

Reported Deaths: 20166
CountyCasesDeaths
Franklin1287491467
Cuyahoga1158082211
Hamilton814091250
Montgomery525571043
Summit484351001
Lucas43359820
Butler39018606
Stark33338929
Lorain25675505
Warren24595303
Mahoning22376603
Lake21211388
Clermont20124253
Delaware18856136
Licking16663222
Fairfield16576204
Trumbull16551482
Medina15612271
Greene15284248
Clark14237306
Wood13292200
Portage13251215
Allen11914239
Richland11607211
Miami10849225
Wayne9146223
Columbiana9034230
Muskingum8906135
Pickaway8664122
Tuscarawas8650250
Marion8642138
Erie8056165
Ashtabula7161179
Hancock6999132
Ross6945161
Geauga6838151
Scioto6534106
Belmont6157174
Union584649
Lawrence5732102
Jefferson5679158
Huron5546122
Sandusky5442126
Darke5420129
Seneca5350128
Washington5320109
Athens523960
Auglaize502187
Mercer487385
Shelby476895
Knox4572112
Madison444366
Ashland435797
Putnam4336103
Defiance432399
Fulton432174
Crawford4040110
Brown402461
Logan387677
Preble3856105
Clinton379166
Ottawa373681
Highland359865
Williams348278
Champaign344859
Guernsey324953
Jackson318254
Perry297350
Morrow291840
Fayette285450
Hardin275365
Henry273467
Holmes2702101
Coshocton269060
Van Wert247264
Adams243256
Pike242835
Gallia240750
Wyandot234556
Hocking220563
Carroll197348
Paulding176542
Meigs148440
Monroe136344
Noble136239
Harrison114138
Morgan109624
Vinton85717
Unassigned03
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