'Homeopathic' treatment contains as much alcohol as whiskey


    A medicine sold at a major drugstore chain could have an unexpected side effect. The "homeopathic" treatment has no age restrictions for purchase but contains as much alcohol as whiskey.By RANDY MACKNBCLOS ANGELES -- Right on its packaging CVS' homeopathic constipation relief says it's safe and non-habit forming. Yvette d'Entremont disagrees."I was an analytical chemist," said d'Entremont.These days d'Entremont uses her mastery of chemistry on YouTube as the 'Sci-Babe" debunking what she calls medicinal myths with science. As for the claim here of a non-habit forming laxative"There was 20% alcohol listed as an inactive ingredient," said d'Entremont. "This is 20% alcohol by volume which means it's 40 proof."That's 40 proof, by standards for purchasing liquor, yet sold over the counter with no age requirements. One of our NBC producer's recorded her teenage daughter buying it without any questions asked. And here's why d'Entremont says that's a problem."It's really just alcohol and water," d'Entremont told us.To prove it, d'Entremont recorded herself opening and drinking six new bottles of the laxative, each has 1 fluid ounce of liquid. She rinsed her mouth with a Diet Coke, waited close to a half-hour and gave herself a breathalyzer test."I was well above the legal limit," said d'Entremont.A 1.1 is what she says she tested, and .08 is the legal limit to be considered drunk. And as far as constipation relief?"There was no laxative effect to it whatsoever," d'Entremont said.The I-Team asked CVS to respond to d'Entremont's on-camera experiment, which some CVS customers have linked to the company's own Facebook page. In an email the pharmacy chain writes; "Homeopathic products are regulated by the FDA the alcohol content in this type of product is not unusual and our products should only be used as directed.""It doesn't do what it claims, to do and it got me drunk," said d'Entremont.D'entremont says alcohol abuse is habit forming, that children can buy it legally should be alarming, she says claims that this bottle can or will produce a laxative effect based on it's ingredients are just crap."I want people to be a little more discerning when they go to pick up a medication," explained d'Entremont. "Because you might end up with something with no medicine and a lot of alcohol in it."Consumers also should be aware of ingredients in homeopathic medicines that are often listed in Latin. If you don't know or can't transcribe Latin, you might be buying something you should not be using. And, check with a doctor before taking any medicines.More information: The FDA limits alcohol in regular, orally ingested, over-the-counter drugs to 10 percent or less. But the government has exempted homeopathic product from that rule after supporters argued that the standards for making those medicines are different.The FDA says it continues to obtain information and comments from stakeholders about the current use of human drug and biological products labeled as homeopathic, as well as the agency's regulatory framework for such products and has reopened the comment period until November 9, 2015.The FDA sent the agency's rules on homeopathic medicines: As a general rule, over-the-counter (OTC) drug products are regulated under the OTC Monograph Process or through the new drug approval process with submission and approval of a new drug application (NDA). In contrast to the OTC Monograph or NDA processes, OTC drug products labeled as homeopathic are manufactured and distributed without FDA approval under the enforcement policies set forth in the FDA's CPG 400.400 entitled "Conditions Under Which Homeopathic Drugs May be Marketed" (the Homeopathic CPG). The Homeopathic CPG includes conditions specific to ingredients, labeling, prescription status, and current good manufacturing practice.Drug products labeled as homeopathic must meet the standards for strength, quality, and purity set forth in the Homeopathic Pharmacopeia of the United States (HPUS). In addition to federal quality standards, the HPUS manufacturing standards are referenced in the General Pharmacy and Good Manufacturing Practices sections of the HPUS, and as specified in their respective monographs. For orally ingested homeopathic drug products, the HPUS specifies the finished product alcohol percentage for the liquid preparation of the official homeopathic tincture of the drug.Orally ingested drug products labeled as homeopathic are temporarily exempted from the maximum concentration limits for alcohol as an inactive ingredient in OTC drug products intended for oral ingestion. See 21 CFR 328.10 and 60 Fed. Reg. 13595 (March 13, 1995). The exemption was added as a result of comments stating that the limits on alcohol were inconsistent with standards in the HPUS and standard methods of making homeopathic drugs.Whenever using any OTC medicine, reading the drug product's labeling for usage and safety information is important. The label tells you what the medicine is supposed to do, who should or shouldn't take it, and how to use it. The FDA encourages health care professionals and consumers to report any adverse reactions related to OTC products labeled as homeopathic to the agency's MedWatch Safety Information and Adverse Event Reporting Program.

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