Genesis Nutrition Ultra Slim dba Genesis Ultra Slim

Selected passages from the FDA letter

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

Passage 1

The claims on your websites and social media websites establish that your "Genesis Ultra Slim Gold" product is intended for weight loss. Therefore, this product is an unapproved new drug sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 355(a) and 331(d), and a misbranded drug sold in violation of sections 502 and 301(a) of the FD&C Act, 21 U.S.C. 502 and 331(a).

Passage 2

FDA confirmed through laboratory analysis that a sample of your "Genesis Ultra Slim Gold" contains undeclared sibutramine and phenolphthalein.

Passage 3

However, under section 201(ff)(3)(B)(ii) of the FD&C Act, 21 U.S.C. 321(ff)(3)(B)(ii), a dietary supplement may not include an article authorized for investigation as a new drug for which substantial clinical investigations have been instituted and made public, unless the article was marketed as a dietary supplement or food before it was authorized for investigation as a new drug.

Passage 4

Your "Genesis Ultra Slim Gold" product is not generally recognized as safe and effective for its above referenced uses and, therefore it is a “new drug” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p).

Passage 5

Your “Genesis Ultra Slim Gold” product is misbranded under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), in that the labeling for this drug fails to bear adequate directions for use.

Passage 6

Your "Genesis Ultra Slim Gold" product is misbranded under section 502(a) of the FD&C Act because the labeling fails to reveal its sibutramine and phenolphthalein content, which are material facts with respect to consequences that may result from the use of this product.

Passage 7

"Genesis Ultra Slim Gold" is also misbranded under section 502(f)(2) of the FD&C Act, 21 U.S.C. 352(f)(2), because the product labeling lacks adequate warnings for the protection of users.

Passage 8

Likewise, "Genesis Ultra Slim Gold" is misbranded under section 502(j) of the FD&C Act, 21 U.S.C. 352(j), because it is dangerous to health when used in the dosage or manner recommended in the labeling.