by Isadora Stehlin
"The reasoning behind [the difference] is that homeopathic products contain little or no active ingredients," explains Edward Miracco, a consumer safety officer with FDA's Center for Drug Evaluation and Research. "From a toxicity, poison-control standpoint, [the active ingredient and strength] was deemed to be unnecessary."
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Another difference involves alcohol. Conventional drugs for adults can contain no more than 10 percent alcohol, and the amount is even less for children's medications. But some homeopathic products contain much higher amounts because the agency has temporarily exempted these products from the alcohol limit rules. "Alcohol is an integral part of many homeopathic products," says Miracco. For this reason, the agency has decided to delay its decision concerning alcohol in homeopathic products while it reviews the necessity of high levels of alcohol. "Overall, the disparate treatment has been primarily based on the uniqueness of homeopathic products, the lack of any real concern over their safety because they have little or no pharmacologically active ingredients, and because of agency resources and priorities," explains Miracco. |
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However, homeopathic products are not exempt from all FDA regulations.
If a homeopathic drug claims
to treat a serious disease such as cancer it can be sold by prescription
only. Only products sold for so-called self-limiting conditions--colds,
headaches, and other minor health problems that eventually go
away on their own--can be sold without a prescription (over-the-counter).
Requirements for nonprescription labeling include:
- an ingredients list
- instructions for safe useat least one major indication
- dilution (for example 2X for one part per hundred, 3X for one part per thousand).
Over the past several years, the agency has issued about 12 warning letters to homeopathic marketers. The most common infraction was the sale of prescription homeopathic drugs over-the-counter. "It's illegal, it's in violation, and we're going to focus on it," says Miracco.
Other problems include:
- products promoted as homeopathic that contain nonhomeopathic active ingredients, such as vitamins or plants not listed in homeopathic references
- lack of tamper-resistant packaging
- lack of proper labeling
- vague indications for use that could encompass serious disease conditions. For example, a phrase like "treats gastrointestinal disorders" is too general, explains Miracco. "This phrase can encompass a wide variety of conditions, from stomachache or simple diarrhea to colon cancer," he says. "Claims need to be specific so the consumer knows what the product is intended to treat and the indication does not encompass serious disease conditions that would require prescription dispensing and labeling."
In addition to enforcement, the agency is also focusing on preventing problems by educating the homeopathic industry about FDA regulations. "Agency representatives continue to meet with homeopathic trade groups to tell them about problems we've had, difficulties we've seen, and trends we've noticed," says Miracco.
FDA is aware of a few reports of illness associated with the use of homeopathic products. However, agency review of those reported to FDA discounted the homeopathic product involved as the cause of the adverse reaction. In one instance, arsenic, which is a recognized homeopathic ingredient, was implicated. But, as would be expected, FDA analysis revealed the concentration of arsenic was so minute there wasn't enough to cause concern, explains Miracco. "It's been diluted out."
Homeopathic Treatment
Homeopathy consists of highly individualized treatments based on a person's genetic history, personal health history, body type, and present status of all physical, emotional and mental symptoms.
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