Aidance Scientific, Inc.
FDA issued a warning letter to Aidance Scientific, Inc. (President Perry Antelman) regarding their 'Terragen HG Formula' product marketed on their website and Amazon storefront. The product was found to be an unapproved new drug under sections 301(d) and 505(a) of the FD&C Act because it is marketed for the treatment of herpes/genital sores — a sexually transmitted infection — without FDA approval, and is not generally recognized as safe and effective for such use. FDA flagged specific claims on the website and Amazon listing that establish drug intent, including references to genital sores treatment, outbreak support, and relief of swelling and pain associated with genital sores. The company was directed to respond within 15 business days with corrective steps, and FDA warned that failure to comply may result in seizure or injunction.
Flagged claims (4)
Genital sores treatment, outbreak support
EFFECTIVE PROTECTION & HEALING: Terragen HG MAX . . . to protect the genital area from irritation and support natural healing.
[R]elief of swelling and pain associated with genital sores.
FAST RELIEF & SOOTHING OINTMENT: . . . treatment cream relieves genital sores and symptoms including tingling, itch, irritation, redness, pain and inflammation. Provides relief quickly with natural, soothing ingredients. For men and woman, for daily use. Discreet packaging.
Required actions (2)
Send your written response to FDAAdvisory@fda.hhs.gov within fifteen (15) business days of receipt of this letter. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
Failure to adequately address any violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.
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