Surprise Ingredient in CVS Medicine

A medicine sold at a major drugstore chain could have an unexpected side effect.

Link: FDA Homeopathic Product Regulations

A key ingredient in a CVS homeopathic medicine, the kind people choose when they want something more "natural" than an over-the-counter product, is alcohol. The packaging on CVS's homeopathic constipation relief describes it as safe and non-habit forming.

Watch the I-Team's full report, tonight at 6 p.m.

Science blogger Yvette d'Entremont, an analytical chemist, conducted an unusual experiment to demonstrate the potential impact. Known as the "Sci-Babe" on YouTube, d'Entremont recorded herself opening and drinking six bottles of the laxative -- each has 1 fluid ounce of liquid.

She rinsed her mouth with a Diet Coke, waited a half-hour and gave herself a breath test that showed she was well above the legal limit. But she said there was "no laxative effect whatsoever."

"It doesn't do what it claims to do and it got me drunk," said d'Entremont. "I want people to be a little more discerning when they go to pick up a medication because you might end up with something with no medicine and a lot of alcohol in it."

The bottle, which listed 20 percent alcohol as an inactive ingredient, is sold over the counter with no age requirements. One of the NBC4 I-Team producers recorded her teen daughter buying the product without any questions asked.

"It’s really just alcohol and water," d'Entremont said.

The I-Team asked CVS to respond to d'Entremont's on-camera experiment, which some customers have linked to the company's Facebook page. In an email, the pharmacy chain responded: "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."

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 tells the I-Team 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.

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.

The FDA sent the I-Team 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:
• Complete and submit the report online at MedWatch Online Voluntary Reporting Form; or
• Download and complete the form, then submit it via fax at 1-800-FDA-0178.

For more information on the FDA's regulatory policies related to drugs labeled as homeopathic, see its Compliance Policy Guide titled "Conditions Under Which Homeopathic Drugs May be Marketed."