# FDA WARNING_LETTER - Cti Science Inc - March 13, 2012

Source: https://www.keypedia.com/records/warning_letter/cti-science-inc/bdb58e08-61ba-4d7b-b235-3e4099817dd6

> FDA WARNING_LETTER for Cti Science Inc on March 13, 2012. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Cti Science Inc
- Inspection Date: 2012-03-13
- Product Type: Food
- Office Name: Cincinnati District Office
- Summary: This FDA Warning Letter (CIN-10-107927-14) dated June 17, 2010, addresses CTI Science, Inc.'s marketing of "OSR#1" on its website, www.ctiscience.com. The FDA determined that OSR#1 is marketed in violation of the Federal Food, Drug, and Cosmetic Act.

The product, marketed as a dietary supplement, does not meet the definition of a dietary supplement under section 201(ff) of the Act because its only listed ingredient, N1,N3-bis(2-mercaptoethyl)isophthalamide, is not a defined dietary ingredient.

Furthermore, claims on the website, such as "helps maintain a healthy glutathione level" and "scavenge free radicals, allowing the body to maintain its own natural detoxifying capacity," classify OSR#1 as a drug under section 201(g)(1) of the Act. It is also deemed a new drug under section 201(p) as it is not generally recognized as safe and effective. The sale of OSR#1 without an FDA-approved application violates sections 301(d) and 505(a) of the Act.

The product is also misbranded under section 502(f)(1) because claims linking it to "Thyroid conditions, hypertension, and

## Related Officers

- [Teresa C. Thompson](https://www.keypedia.com/people/teresa-c-thompson/b41b98e5-2a7c-4f19-923b-058a197a8fd4)

Company: https://www.keypedia.com/companies/cti-science-inc/561194ab-57d7-4796-9931-816dc2e2003a

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22