iSlim, LLC

Selected passages from the FDA letter

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

Passage 1

Your “Alfia Weight Loss Capsules” product is a drug as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1) because it is intended to diagnose, cure, mitigate, treat, or prevent disease and/or affect the structure or function of the body.

Passage 2

There is no FDA-approved application in effect for “Alfia Weight Loss Capsules.” Introduction or delivery of this product into interstate commerce violates sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).

Passage 3

Your “Alfia Weight Loss Capsules” product is misbranded under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), in that its labeling fails to bear adequate directions for use.

Passage 4

Your “Alfia Weight Loss Capsules” product is misbranded under section 502(a) of the FD&C Act because the labeling fails to reveal the sibutramine content, which is a material fact with respect to consequences that may result from the use of this product.

Passage 5

“Alfia Weight Loss Capsules” is also misbranded under section 502(f)(2) of the FD&C Act, 21 U.S.C. 352(f)(2), because the product’s labeling lacks adequate warnings for the protection of users.

Passage 6

Likewise, “Alfia Weight Loss Capsules” 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.