The recent recall of Hyland's Teething Tablets exposes a major flaw in the FDA's regulation of homeopathic remedies: Makers of these products used by countless families are allowed to package the remedies however they see fit, even if that means without child-resistant caps.
This October, Standard Homeopathic, maker of homeopathic remedies for adults and children recalled their Hyland's Teething Tablets, when the FDA tested the tablets after receiving adverse reaction reports and found inconsistent levels of belladonna within the product.
Belladonna is one of several substances that exist in the teething remedy and is said to aid in the relief of irritability, redness and pain in children's teething gums. However, in large quantities, belladonna is poisonous.
The FDA was concerned about reports of reactions that they say were consistent with belladonna poisoning. The product's packaging does not include a child-resistant cap, which could have easily led to overdose.
The company claims there were differences in interpretation of testing data, but still issued a recall. A new improved version of the product is set to hit shelves in 2011, according to a story on the website NewHope360.com, which reports on the natural and organic product industry.
Standard Homeopathic's CEO John P. Borneman said in an interview with NewHope360 that the company has mulled a decision for the last 25 years to add child-resistant caps to their products.
"Because, to me, a child-resistant cap signals to parents that a product might not be safe. But moms now are used to everything having child-resistant caps on them and that is the direction we are moving in, too. The good part is this new packaging might provide more peace of mind to parents," said Borneman.
While countless numbers of families have safely used homeopathic remedies throughout the last several decades and many report success from such methods, homeopathic products are not regulated by the FDA in quite the same way as other over-the-counter (OTC) drugs are.
A primer on homeopathy on the website of The National Institutes of Health National Center for Complementary and Alternative Medicine (NCAM) describes the regulatory inconsistency of homeopathic products:
"... because homeopathic products contain little or no active ingredients, they do not have to undergo the same safety and efficacy testing as prescription and new OTC drugs."
The U.S. Food and Drug Administration (FDA) does require that homeopathic remedies meet certain legal standards for strength, purity and packaging. The labels on the remedies must include at least one major indication (i.e., medical problem to be treated), a list of ingredients, the dilution and safety instructions. In addition, if a homeopathic remedy claims to treat a serious disease such as cancer, it needs to be sold by prescription. Only products for self-limiting conditions (minor health problems like a cold or headache that go away on their own) can be sold without a prescription."
In other words, they are not regulated before being offered to the public over-the-counter, and their manufacturers are not required to package their products in a certain manner. Only after the fact, as in the case of the adverse reports, are they tested for safety or efficacy.
So, just who should be responsible here? The homeopathic manufacturers who should modernize their packaging to be consistent with other medicinal products kept in the home or the FDA, which once again relies on doing its job after the fact?
What is your opinion? Have you used homeopathic products for your children? If so, how do you feel about the recall? Have your say below:
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