www.weightcrunchshop.com

Selected passages from the FDA letter

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

Passage 1

Certain products offered for sale by www.weightcrunchshop.com are drugs within the meaning of section 201(g) of the FD&C Act [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body. These drugs are also new drugs as defined by section 201(p) of the FD&C Act [21 U.S.C. § 321(p)], because they are not generally recognized as safe and effective for their labeled uses.

Passage 2

No approved applications pursuant to section 505 of the FD&C Act are in effect for these products. Accordingly, their introduction or delivery for introduction into interstate commerce violates sections 301(d) [21 U.S.C. § 331(d)] and 505(a) of the FD&C Act.

Passage 3

Because “Orsema 0.25 mg” and “Orsema 0.50 mg” are prescription drugs intended for conditions that are not amenable to self-diagnosis and treatment by a layperson, adequate directions cannot be written such that a layperson can use the products safely for the intended use. Consequently, the labeling for the drugs fails to bear adequate directions for use, causing them to be misbranded under section 502(f)(1) of the FD&C Act.

Passage 4

By offering these drugs for sale to U.S. consumers, www.weightcrunchshop.com is causing the introduction of misbranded drugs into interstate commerce in violation of section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].

Passage 5

Additionally, FDA has observed that www.weightcrunchshop.com offers prescription drugs for sale without a prescription. For example, your website offers semaglutide drug products marketed as “Ozempic 0.25 mg,” “Ozempic 0.5 mg,” and “Ozempic 1 mg.” Your website states, “Ozempic is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Buy Ozempic Online without Prescription with Credit Card.”

Passage 6

Furthermore, www.weightcrunchshop.com offers oxycodone 15 mg and 30 mg tablets described as “moderately potent opioid analgesic, generally indicated for the relief of moderate to severe pain.” Your website, www.weightcrunchshop.com also states that “oxycodone is for sale without a prescription.”

Passage 7

Under U.S. law, prescription drugs can be dispensed only pursuant to a prescription from a healthcare practitioner licensed by law to administer prescription drugs. By offering the aforementioned drugs without requiring a prescription, www.weightcrunchshop.com jeopardizes patient safety and misbrands the drugs under section 503(b)(1) of the FD&C Act. Dispensing a prescription drug without a prescription is an act which results in the drug being misbranded while held for sale, in violation of section 301(k) of the FD&C Act [21 U.S.C. § 331(k)].