Many entrepreneurial companies have been moving forward on CBD infused food products, but from an FDA stance, these are illegal to sell. (CBD oil is derived from hemp/no THC.) It is hard to believe with as many items we hear about including CBD infused gummies, drinks, and other foods. Unfortunately, many state and local agencies have taken a less stringent stand against use of CBD oil in food and dietary supplements. Not that the FDA has taken a hard stance on the chemical. From a Post Star article, "Until last year, there was a federal ban on CBD. Not that the FDA enforced it. Beyond firing off a few letters ordering manufacturers to stop making unproven health claims, the FDA made no efforts to stop commerce. After all, CBD never killed anyone."
A Science News article on CBD oil, it states the science behind the benefits is largely unknown. It has been approved as a drug to treat epilepsy in children. But how it works and the impact on the average person...there has not been enough research.
The only clear benefit in food is the mark-up in price. Adding CBD oil to a food item allows the seller to jack up the price. And with no standards, it is easy for the amount added to be extremely small to perhaps nonexistent. So before stopping off to buy your CBP infused smoothie, you may want to think about what you are really buying. A this point, just expensive, technically illegal, hype.
https://poststar.com/news/national/selling-cbd-in-food-is-illegal-fda-says-so-why/article_f3e378c4-f75d-5667-a83c-d05690ed9d43.html
Selling CBD in food is illegal, FDA says. So why are so many retailers selling it?
Sam Wood Tribune News Service
March 31, 2019
PHILADELPHIA — Step away from those gummy bears. Surrender the smoothie. Put down that ice cream and that hot sauce.
Under federal law, if those products contain CBD, they’re illegal.
CBD, or cannabidiol, is derived from cannabis. It is a non-intoxicating compound reputed to have several health benefits. And this year, CBD’s popularity has exploded.
It’s added to skin creams, oils, and dietary supplements. Soon, those products will be for sale at CVS, the largest drug store chain in the U.S. Anecdotal accounts have claimed CBD to be somewhat effective as an anti-psychotic, a calming agent, and a pain reliever.
CBD is also being added to foods. It’s in the kombucha called Cannabliss at Weavers Way co-ops in Philadelphia. It’s in the muffins, coffee and lollipops at the Hip Hemp Cafe. Rocky’s Hot Sauce, produced in Oreland, Pennsylvania, purports to pack 100 milligrams into tiny bottles of their fiery elixir. Restaurants structure entire menus around it as an ingredient.
Though regulators are turning a blind eye now, it may become a source of serious agita for vendors who lace their edibles and drinks with it.
The U.S. Food and Drug Administration absolutely prohibits the addition of CBD to prepared foods. That’s despite language in the 2018 Farm Bill that loosened restrictions on the interstate commerce of hemp — cannabis that has less than 0.3 percent of THC — and its derivatives such as CBD. Even advocates and researchers advise caution before consuming it.
If you’re confused, join the club.
The federal stance has triggered crackdowns by a number of states and municipalities. The New York City Health Department sent letters last month warning that after October 1, violators will face fines, “embargoes” and a slashing their all-important health letter grades. Los Angeles will soon start penalizing companies who have “adulterated” foods with CBD (though a law pending in the California legislature could permit sales statewide). States banning CBD in food include Ohio, Maine, North Carolina, and South Carolina.
State regulators in Pennsylvania and New Jersey see wiggle room in the law and are taking a laissez-faire approach, declining to take action until the FDA gives more guidance.
But major retailers such as Whole Foods are exercising caution. “Whole Foods Market will not sell products containing CBD (cannabidiol) until all issues regarding the regulatory status are completely resolved to our satisfaction,” a spokeswoman said.
So how did this happen?
Until last year, there was a federal ban on CBD. Not that the FDA enforced it. Beyond firing off a few letters ordering manufacturers to stop making unproven health claims, the FDA made no efforts to stop commerce. After all, CBD never killed anyone.
Because CBD is extracted from cannabis, it long has been considered a Schedule 1 substance, along with all other forms of the marijuana plant and its derivatives. But because CBD doesn’t get anyone high, it existed in a gray area. CBD oils and tinctures quietly were sold at health food stores and head shops.
Last summer, the FDA approved a highly-purified form of CBD as a treatment for some rare forms of childhood epilepsy. The CBD drug, Epidiolex by GW Pharmaceuticals, may cost uninsured patients up to $32,500 a year. The FDA’s ruling initially was cheered by activists and advocates who assumed that all forms of CBD would now be legal. Not so.
“Once CBD was approved as a drug, it became prohibited to be included in a food or a nutraceutical supplement,” said Joe Reardon, assistant commissioner for consumer safety for the North Carolina Department of Agriculture. “You can’t add a drug to a food.”
Before FDA Commissioner Scott Gottlieb abruptly resigned earlier this month, he told Congress the agency would hold listening sessions to discuss hemp and its derivatives. A public meeting is scheduled in April to explore how CBD could be sold legally in food beverages and supplements.
The FDA can listen. But even they are bound by law.
The drug exclusion rule prevents any active substance in a pharmaceutical from being added to a food, points out Erica Lietzan, an associate professor at the University of Missouri School of Law.
“It’s not even ambiguous under the federal Food Drug and Cosmetic Act,” said Lietzan, who has written extensively about the legality of CBD. “It’s not controversial and not something that can be debated. The law isn’t gray at all.”
The FDA, however, could just ignore CBD. “I think that’s what they’ve been doing,” she said. “You look around and there’s CBD everywhere.” True that. The agency can also choose to selectively enforce the statute. “There are plenty of examples of them doing that. For instance, you can bring a month supply of an unapproved drug into the country for personal use,” she said. “But (selling food with CBD) is risky. The FDA could decide to make an example out of someone.”
Given the FDA’s priorities, enforcement of the statute is likely to remain sporadic. And for most merchants, the rewards for selling the products outweigh the risk.
Rest of article - https://poststar.com/news/national/selling-cbd-in-food-is-illegal-fda-says-so-why/article_f3e378c4-f75d-5667-a83c-d05690ed9d43.html
https://www.sciencenews.org/article/cbd-product-boom-science-research-hemp-marijuana
The CBD boom is way ahead of the science
Strict regulations have stunted research on cannabidiol, but that hasn’t hampered product popularity
BY LAURA SANDERS 6:00AM, MARCH 27, 2019
A few months back, a new storefront appeared in my small Oregon town. Its shelves were packed with tinctures, jars of salve, coffee beans, bath bombs — even beard oil. This motley collection shared a single star ingredient: CBD.
Produced by the cannabis plant, CBD is the straitlaced cousin of marijuana’s more famous component — the THC that delivers a mind-swirling high. CBD, or cannabidiol, has no such intoxicating effects on the mind. Yet the molecule has captured people’s attention in a profound way, sold as a remedy for pain, anxiety, insomnia and other ailments — all without the high.
That neighborhood shop, CBD Scientific, is far from alone in its efforts to sell people on the benefits of CBD, which is found in both marijuana and hemp, two versions of the Cannabis sativa plant. CBD is popping up in products in pet stores, coffee shops and the health and beauty sections of mainstream grocery stores. It’s even being brewed into beer. I left the shop with a $5 bottle of water infused with “5,000,000 nanograms” of CBD.
So far, messages of CBD’s purported health benefits come from people trying to sell CBD products — not from scientists, says Margaret Haney, a neurobiologist who directs the Marijuana Research Laboratory at Columbia University. A gaping chasm separates the surging CBD market and the scientific evidence backing it. While there are reasons to be excited about CBD, the science just isn’t there yet, Haney says.
Rest of article - https://www.sciencenews.org/article/cbd-product-boom-science-research-hemp-marijuana
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