Alternative Autism Treatment OSR#1 is Dangerous and Unregulated Drug: FDA
An autism treatment known as OSR#1, which is marketed as a dietary supplement, is actually an unregulated drug with potentially dangerous side effects according to federal drug safety officials.
The FDA has issued a warning letter to Boyd E. Haley, president of CTI Science, Inc., notifying him that OSR#1 is in violation of federal regulations because it is a drug being sold as a dietary supplement. The FDA letter also says that advertising for the drug is misleading, because it does not warn consumers of OSR#1 side effects, which the FDA says can include pancreas problems and other reactions.
The CTI Science website describes OSR#1 as a “toxicity free, lipid soluble antioxidant dietary supplement that helps maintain a healthy glutathione level.” However, the FDA describes it as a drug, saying that the only ingredient listed as a dietary ingredient in the product isn’t one. The FDA says that the advertising for OSR#1 mentions thyroid problems, hypertension and diabetes are linked to glutathione levels, and boasts that OSR#1 helps maintain a health glutathione level. The agency interprets these and other statements as claims that OSR#1 is meant to treat a disease.
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OSR#1 was highlighted in January by the Chicago Tribune in a story about unsubstantiated autism cures and treatments. The original compound was developed for mining wastewater treatment. The Tribune article said Haley claims to have tested the formula on rats and 10 human test subjects. However, the article says Haley broke off communications with the paper when reporters asked him for documents on the testing.
Federal law requires that no new drug be introduced or delivered into interstate commerce unless the FDA has approved an application for it. OSR#1 has no such approval.
The FDA letter also says that, according to data they have on Haley’s own animal studies, side effects of OSR#1 included soiling of the anogenital area, alopecia on the lower trunk, back and legs, a dark substance on the lower trunk and anogenital area, abnormalities of the pancreas, and lymphoid hyperplasia. The website itself mentions that there have been reports of temporary diarrhea, constipation, and minor headaches, but says it is unclear if these are connected to the drug.
Haley has 15 days to respond to the allegations in the letter. Failure to do so could result in seizures and injunctions, as well as other actions.
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