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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: 665285

Reported Deaths: 12697
CountyCasesDeaths
Marion910581653
Lake48637887
Allen36050641
Hamilton32231398
St. Joseph30243514
Elkhart25484420
Vanderburgh21315382
Tippecanoe20185205
Johnson16425361
Porter16053276
Hendricks15899301
Clark12032182
Madison11779321
Vigo11672231
Monroe10394164
Delaware9879179
LaPorte9821198
Howard9095199
Kosciusko8588111
Bartholomew7504147
Warrick7445153
Hancock7439134
Floyd7255172
Wayne6654192
Grant6453157
Boone611991
Morgan6118126
Dubois5933112
Dearborn550669
Cass5477100
Marshall5446105
Henry542695
Noble510978
Jackson465567
Shelby462591
Lawrence4193113
Gibson404985
Harrison402764
Clinton397053
Montgomery390584
DeKalb387178
Knox357885
Miami357863
Whitley350638
Huntington348377
Steuben339855
Wabash333076
Putnam331960
Ripley327862
Adams325149
Jasper318443
White298052
Jefferson295974
Daviess285696
Fayette272656
Decatur271388
Greene262280
Posey261432
Wells258975
Scott251450
LaGrange242170
Clay241444
Randolph225877
Spencer219330
Jennings216344
Washington213027
Sullivan203639
Fountain202542
Starke189251
Owen183453
Fulton179637
Jay178528
Carroll176919
Perry173836
Orange171351
Rush165422
Vermillion161542
Franklin159735
Tipton149241
Parke140116
Pike128433
Blackford120627
Pulaski107544
Newton96732
Brown95240
Benton92413
Crawford92113
Martin80314
Warren75914
Switzerland7558
Union67510
Ohio54111
Unassigned0434

Ohio Coronavirus Cases

Data is updated nightly.

Cases: 976230

Reported Deaths: 17501
CountyCasesDeaths
Franklin1127971251
Cuyahoga966701881
Hamilton737981067
Montgomery47453923
Summit40562831
Butler35750531
Lucas35685720
Stark29548826
Warren22539275
Lorain22149424
Mahoning19556551
Lake18509332
Clermont18484205
Delaware16576121
Licking15063194
Fairfield14622188
Trumbull14397424
Greene13636221
Medina13484237
Clark12352256
Wood11633170
Portage11104172
Allen10815216
Richland10360188
Miami10055194
Muskingum8224117
Columbiana8165210
Pickaway8085111
Tuscarawas8065232
Marion8015127
Wayne7915199
Erie6948146
Ross6170132
Geauga6105142
Hancock6021121
Ashtabula5998154
Scioto599188
Lawrence527186
Union515641
Darke5046116
Belmont4990137
Huron4848108
Jefferson4831137
Sandusky4791112
Washington473696
Seneca4720111
Athens465849
Mercer459181
Auglaize456682
Shelby442579
Knox4053105
Putnam400393
Madison394755
Fulton382561
Ashland381983
Brown374352
Defiance373588
Crawford359598
Logan356973
Preble353887
Clinton342055
Highland328451
Ottawa325171
Williams303268
Jackson291246
Champaign290149
Guernsey288745
Perry270748
Fayette269843
Morrow261137
Henry247361
Hardin246859
Holmes244097
Coshocton240056
Van Wert230257
Gallia223538
Adams218139
Pike216728
Wyandot212050
Hocking194954
Carroll181743
Paulding160834
Meigs136031
Noble129233
Monroe117137
Morgan101620
Harrison100731
Vinton76613
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