FDA warning letter · Drugs

Greenway Herbal Products LLC

Issued · Posted by FDA

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Based on our review, these products are unapproved new drugs sold in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a).

Passage 2

Furthermore, these products are misbranded drugs under section 502 of the FD&C Act, 21 U.S.C. § 352.

Passage 3

At the University Of Chicago, a team led by Marsha Rosner discovered that CBD curbs COVID-19 cell infections in lab experiments. By using small doses of CBD (approximately what patients would receive in an oral drug), the team discovered that CBD didn’t stop the spread of COVID-19 in test tubes. Rather, it started acting as soon as the virus entered healthy cells, blocking it from making copies of itself, thanks to interferon (an inflammatory protein).

Passage 4

In the new study, author Richard van Breemen reveals that cannabinoids can help prevent a Sars-Cov-2 infection., [sic] How does that work? It seems that they block Covid-19 from entering your healthy cells. And, while all cannabinoids may be useful, two offer the most protection: CBGA and CBDA. (Also known as cannabigerolic acid and cannabidiolic acid.)

Passage 5

CBD shows significant potential in the fight against Covid-19, mainly due to its significant anti-inflammatory properties. The latest research shows that cannabis and CBD might drastically improve Covid-19 symptoms. It could do so by lowering cytokine storms and protecting lung tissue from inflammation.

Passage 6

More recently, THCV was highlighted in connection with cannabinoids’ anti-inflammatory impact on Covid-19- lung inflammation. The research, published in the Nature journal Scientific Reports, suggests that cannabigerol (CBG) and low-dose THCV reduces inflammation in Covid patients’ lung cells.

Passage 7

It showed that CBD could help reduce cytokine storms . . . and unrestricted lung inflammation in patients with Covid-19.

Passage 8

In direct comparison studies, the unique formulation of cannabinoids used in the Tanasi CBD product line was as effective as dexamethasone in reducing cytokine storms. Thus [sic] it is not surprising that customers using the Tanasi CBD/CBDA products report that they are very effective at reducing a number of inflammatory conditions.

Passage 9

In the new study, author Richard van Breemen reveals that cannabinoids can help prevent a Sars-Cov-2 infection. It seems that they block Covid-19 from entering your healthy cells. And, while all cannabinoids may be useful, two offer the most protection: CBGA and CBDA. . . . Cannabis and Covid | CBDa prevents Covid-19 infection | Tanasi CBD with CBDa

Passage 10

CBD Covid Relief | Cannabis Treatment for COVID 19 . . .