American Premium Water Corp. (HIPH)

[StevenCohen]

$HIPH -Has its #CBD infused water Lalpina Hydro #CBD & its Plant +Body #CBD topicals. FDA sent guidance on CBD to White House, could be big catalyst for HIPH . See below and link to law 360
https://plantbodyessentials.com/

FDA Sends New CBD Guidance To White House Budget Office

Law360 (July 23, 2020, 6:04 PM EDT) -- The U.S. Food and Drug Administration has submitted draft policy for regulating the CBD market to the White House for approval, signaling that long-awaited clarity for how the federal government will oversee the consumer hemp industry may be on the horizon.

The White House Office of Management and Budget received the FDA's proposed "Cannabidiol Enforcement Policy" and draft guidance for the industry on Wednesday, according to the office's website.

It is unclear how long it will take for the administration to review the rule and whether it will approve its public release. An FDA spokesperson said Thursday that the agency could not comment on unpublished guidance.

While the FDA has not yet released regulations governing how CBD can be marketed as a dietary supplement, the agency has been warning CBD producers in recent months against making questionable or unfounded health claims about their products. More specifically, the agency has targeted CBD companies that have marketed their products as treatments or cures for COVID-19.

In November, the agency said it would not grant CBD a status of "generally recognized as safe." The agency's position since March is that "it is currently illegal to market CBD by adding it to a food or labeling it as a dietary supplement."

Jonathan Havens, co-chair of the cannabis practice at Saul Ewing Arnstein & Lehr LLP, said it's unclear how prescriptive the proposed guidelines are. Industry stakeholders will be looking to see whether the FDA will focus on CBD dietary supplements marketed with unproven health benefits or apply a CBD dosage threshold that would trigger stricter enforcement, he said.

"I find it hard to believe FDA will all of a sudden say that CBD ingestible products are OK, given the agency's consistent statements to the contrary," Havens said. "On the other hand, that's essentially what FDA has suggested by not going after a single CBD ingestible unless it bears aggressive claims."

Another FDA cannabis policy, regarding best practices for researchers investigating medical uses of cannabinoids, was released on Tuesday, just under two months after it was submitted to the OMB. The guidance acknowledged that that the legal definition of hemp — which is based on having less than 0.3% THC on a dry-weight basis — has limited utility once the cannabinoid compounds have been extracted from the plant and processed.

Accordingly, the guidance included a new rubric for how to measure the THC concentration in solutions, including intermediates, by-products and finished products. Industry attorneys said the methodology outlined in the guidance could come into play when the agency begins regulating CBD in dietary supplements.

Also on Tuesday, the U.S. Department of Commerce's National Institute of Standards and Technology announced that that it had initiated a program to help laboratories more accurately test for cannabinoids. Under the Cannabis Quality Assurance, or CannaQAP, program, NIST said it will send hemp oil samples to various labs and ask them to analyze the samples' concentration of THC, CBD and other cannabis compounds.

"After collecting responses, NIST will publish the measurements the labs obtained," the agency said in a statement. "That data will be anonymized so that the names of the individual labs are not revealed. However, the results will show how much variability there is between labs. Also, NIST will publish the correct measurements, so each lab will be able to see how accurate its measurements were and how it performed relative to its peers."

NIST said it could publish its data from the first round of exercises after six to 12 months.

https://www.law360.com/articles/1294855/fda-sends-new-cbd-guidance-to-white-house-budget-office