Due to the array of unproven alternative health treatments, U.S. authorities are seeking to remove any products from the market and to issue new warnings to consumers. Leading the charge is the U.S. Food and Drug Administration (FDA).
Central to the FDA campaign is a draft proposal for regulating homeopathic medicines. These are the types of medicines that are clinically unproven, which are on the edge of pharmaceutical products, but which are presented as ‘legitimate medicines.’ Here remedies are put on drug store shelves alongside licensed medications.
The FDA will focus on those products deemed, by assessment, to carry the most significant risks to the elderly and to young children. Also included in the first tranche are those medications presented as ‘curing’ serious diseases. In its review, Pharmaceutical Processing reports, the FDA does not intend to target health remedies considered to be low risk.
Many of the remedies contain diluted drugs, vitamins and minerals, some down to such a low level that little (if any) of the original compound remains. The overall value of the homeopathic market in the U.S. is valued at $3 billion.
According to FDA Commissioner Dr. Scott Gottlieb: “People may be putting their trust and money in therapies that bring little or no benefit in combating their ailments, or worse — in products that may cause serious and even irreparable harm.”
Prior to the FDA statement, the U.S. government agency does not review the safety or efficacy of homeopathic medicines prior to sale. However, some products have been associated with serious safety issues, often in relation to possessing toxic ingredients.
One example is a warning issued by FDA about teething tablets marketed by Hyland’s Homeopathic. These tablets were linked to seizures, which was due to later chemical analysis showing the tablets contained belladonna (nightshade). Other dangerous ingredients recovered from some homeopathic remedies include nux vomica (strychnine).
The FDA proposal is out for 90 days, pending public comment. This represents the first FDA review of homeopathic remedy guidance since 1988.
