Anabolic Laboratories Inc
1 extracted findings · 1 model-assigned issue type
FDA source excerpt, selected passage
The claims on your websites establish that these products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or…
Findings and supporting evidence
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The products are unapproved new drugs and misbranded due to disease claims on the website.
Supporting FDA text
Source excerpt · automated text-match checkThe claims on your websites establish that these products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering this product for introduction into interstate commerce for such uses violates the Act.
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What FDA requested
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- Notify this office in writing of the specific steps taken to address the violations, including an explanation of each step taken to prevent recurrence and copies of related documentation.
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.