Homeopathy has been a controversial subject for years, as it gathered followers among patients who say its remedies are effective and safe, while also being criticized by most researchers who explain its treatments offer no more aid than a placebo.
After issues within the industry in recent years, the Food and Drug Administration announced it wants to reexamine how it oversees homeopathic products. According to the current law, these products can be produced and marketed without approval from regulators.
Should the FDA be the regulator of homeopathic cures such as Cold-Eeze the same way it does with regular drugs such as Advil?
Thousands of public comments have been sent to the FDA before of two days of hearings that start on Monday. The agency announced it wants more research and data to “better assess the risks and benefits” of homeopathic remedies, which have gained a permanent spot on modern pharmacy shelves, often being sold alongside regular pharmaceutical drugs.
The FDA has not decided yet about whether to modify how it judges homeopathic products, said Cynthia Schnedar, director of the Office of Compliance at the FDA’s Center for Drug Evaluation and Research.
The FDA has emitted almost 40 warning letters since 2009 to firms which produce homeopathic products, Schnedar explained. Last month, the agency issued a warning to consumers not to purchase over-the-counter asthma products which are labeled as homeopathic, explaining they have not been revised for safety and effectiveness.
In 2009, the FDA advised consumers to stop taking several types of Zicam cold treatments after news of more than 130 cases of people losing their sense of smell; the company recalled its products.
In 2010, Hyland’s Teething Tablets were called back after reports of negative reactions in some children; the tablets were reintroduced on the market with a new formulation.
Homeopathic remedies have had the same legal status as regular drugs since 1938, when then-New York Sen. Royal Copeland, who was a homeopathy enthusiast, helped promote a landmark drug law through Congress.
In the 1970s, lawmakers offered the FDA the right to review the safety and effectiveness of over-the-counter remedies. But the agency refused reviewing homeopathic treatments, while its last evaluation of policies was back in 1988. It has permitted most prescription but also nonprescription homeopathic remedies to go to market without prior approval.
Homeopathic products, which are derived from minerals, plants and other substances, often are designated to individual patients.
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