11-11-11 Brands

Selected passages from the FDA letter

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

Passage 1

your Mood33 Hemp Infused Herbal Tea products are adulterated under section 402(a)(2)(C)(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 342(a)(2)(C)(i), because they bear or contain an unsafe food additive.

Passage 2

it is a prohibited act to introduce your Mood33 Hemp Infused Herbal Tea products into interstate commerce under sections 301(ll) and 301(a) of the FD&C Act, 21 U.S.C. 331(ll) and 331(a).

Passage 3

with these products there is a risk of unintended consumption of the CBD ingredient by consumers, which is exacerbated due to the failure of the label to list CBD as an ingredient.

Passage 4

the Joy Peach-Yerba Mate and Energy Raspberry Lemon-Guayusa-Green Tea varieties also appear to contain caffeine. Evidence suggests that CBD may affect caffeine metabolism and may increase and/or prolong caffeine’s effects.

Passage 5

There is no food additive regulation which authorizes the use of CBD.

Passage 6

the use of CBD in your products does not satisfy the criteria for GRAS status under 21 CFR 170.30.

Passage 7

CBD added to a conventional food is a food additive under section 201(s) of the FD&C Act and is subject to the provisions of section 409 of the FD&C Act.

Passage 8

CBD is not approved for use in any conventional food.

Passage 9

the introduction or delivery for introduction into interstate commerce of those products is a prohibited act under section 301(ll) of the FD&C Act.