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FDA to Crack down On High-Risk Homeopathic Drugs

(WASHINGTON) – US health officials plan to address an increasing number of untested alternative drugs, with a focus on products containing hazardous ingredients that are sometimes associated with serious injury and death.

On Monday, the Food and Drug Administration issued a new proposal for the regulation of homeopathic medicines, which had long been on the margins of conventional medicine. The agency intends to address the products that pose the greatest risk to safety, including those that are marketed for children or serious diseases.

In the government, the vast majority of low-risk products would remain on the market. The most popular homeopathic brands include Zicam Allergy Relief and Cold-Eeze.

Long regarded by scientists as a form of today’s snake oil, homeopathic products are treated as drugs under the law, but not supported by modern science. Most remedies contain highly diluted drugs, vitamins and minerals.

Once a niche market, homeopathic products have become a $ 3 billion industry, according to the FDA.

Homeopathic products are similar to food supplements because the FDA does not review their safety or efficacy before selling them. However, unlike nutritional supplements, homeopathic medications may indicate that they are intended for certain symptoms and medical conditions, just like medications.

A handful of products in recent years have been exposed to major safety issues, usually with potentially toxic ingredients.

Last year, the FDA warned consumers of the risks associated with Hyland homeopathic tablet computers after being linked to seizures and deaths in infants and children. The FDA tests later confirmed that the products contained high levels of belladonna, also known as belladonna, a poisonous herb that has long been used in low doses in homeopathic medicine. The products were recalled in April.

In 2009, the FDA ordered Zicam to discontinue the marketing of three products containing zinc gluconate after over 100 users reported having lost their sense of smell. The other dangerous ingredients used in homeopathic products are nux vomica, which contains strychnine. Regulatory authorities have issued five warning letters this year to companies that sell products with nightshades or nux vomica.

The FDA has stated that its proposal also covers products that claim to treat serious illnesses such as cancer or that are administered through unconventional routes such as injection or eye drops. Regulatory authorities can send warning letters, confiscate products or take criminal action against companies that ignore federal guidelines.

The agency will comment on the proposal for 90 days before finalizing the plan.

Consumer advocates have said that the FDA plan makes sense for products that are generally harmless, but which can be dangerous if producers deviate from traditional ingredients, dosage and production.

The FDA has not updated the regulation of homeopathic medicines since 1988, when the industry was essentially exempt from mandatory production standards for traditional medicines, such as labeling ingredients on product labels.

Hundreds of homeopathic medicines are now sold with over-the-counter drugs like Tylenol and Aspirin in pharmacies in the United States. The National Institutes of Health has stated that there are few indications that homeopathic medicines are effective for the treatment of a specific condition.

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