FDA Statement on HGH

Human growth hormone (HGH) is the active ingredient in several prescription drugs that have been approved by the FDA for a number of medical conditions, including the treatment of growth disorders in children and adult growth hormone deficiency. No HGH drug has been approved for “anti-aging,” and products containing HGH are not dietary supplements.

Consumers should never purchase any product claiming to contain HGH from internet websites. The FDA has taken enforcement action against unapproved HGH products and companies or individuals that illegally market or distribute hGH. These actions include seizing illegal products and referring cases to the U.S. Department of Justice for criminal prosecution and forfeiture of any monies made from the illegal distribution of HGH.

Additional Background Information:
Since synthetic HGH is an FDA-approved drug, are doctors free to prescribe it for off-label uses like anti-aging, or is prescribing/administering HGH for anti-aging illegal?
The FDA does not approve active ingredients by themselves (such as a “synthetic HGH”). Instead, the drug approval process gives approvals to specific drug products that contain active ingredients (for example, Genotropin is a synthetic HGH-based drug that has been approved by FDA for specific medical conditions, including the treatment of growth disorders in children and adult growth hormone deficiency). However, not every approved drug containing hGH has the same approved use(s). The safety and effectiveness of unapproved HGH drugs have not been established; nor have the safety and effectiveness of using an approved HGH drug for purposes other than the medical conditions for which the drug was approved been established.

Health care professionals should follow the recommended indications and dosing described in the labeling of approved hGH drugs. While federal law (21 USC 333(e)) prohibits distributing HGH (even administration by licensed physicians) for unauthorized uses, the FDA does not generally monitor prescribing practices of doctors.

How does the FDA and DEA intersect on this? What authority does DEA have regarding HGH?
According to the law (21 USC 333(e)), FDA and DEA both have authority to investigate HGH offenses. You should contact the DEA with any questions about their enforcement actions regarding HGH.

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