# FDA WARNING_LETTER - HCG Platinum, LLC - November 28, 2011

Source: https://www.keypedia.com/records/warning_letter/hcg-platinum-llc/d1ec5858-4dbf-482b-aa6a-1ba34a59cf4c

> FDA WARNING_LETTER for HCG Platinum, LLC on November 28, 2011. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: HCG Platinum, LLC
- Inspection Date: 2011-11-28
- Product Type: Drugs
- Office Name: Department of Health and Human Services
- Summary: On November 28, 2011, the FDA and FTC issued a Warning Letter to HCG Platinum, LLC, and Rightway Nutrition, LLC, specifically addressing CEO Kevin Wright. The letter stated that the products "HCG Platinum," "HCG Platinum X-30," and "HCG Platinum X-14" are unapproved new drugs and misbranded, violating sections 301, 505, and 503 of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §§ 331, 355, 353]. The FTC also cited violations of the FTC Act, 15 U.S.C. § 41 et seq., for unsubstantiated advertising claims.

The products' labeling and website (www.hcgplatinum.com) made claims such as "Lose up to 1 pound a day," "rapid weight loss," "Fat burning," "Muscle Growth," "Blood Flow," "Appetite Control," "Higher Energy," and "improve blood sugar levels," which classify them as drugs under section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)]. They are also considered "new drugs" under section 201(p) [21 U.S.C. § 32

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Company: https://www.keypedia.com/companies/hcg-platinum-llc/04a3869d-27e2-4b51-a274-79f03479d5ee

Office: https://www.keypedia.com/offices/department-of-health-and-human-services/cecfcda4-4afa-4a1f-a7b7-a020b79f9861