FDA warns of potentially harmful homeopathic products
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FDA warns of potentially harmful homeopathic products The US FDA is warning of the risks of potentially harmful homeopathic products which may not meet safety, quality or labelling standards, and increasing efforts to protect patients from these products. Homeopathic products are made from ingredients derived from plants, animal or human sources, and minerals and chemicals, which have the potential to cause harm if they are poorly manufactured. They may be contaminated or contain levels of potentially toxic ingredients that exceed labelling or safe levels, and may be marketed as alternative treatments for serious or lifethreatening diseases. Moreover, some of the products may not conform to traditional homeopathic principles. In 2017, the FDA issued draft guidance on the agency’s risk-based enforcement approach to products labelled as homeopathic. The FDA has now revised the 2017 draft guidance, providing details of a risk-based enforcement policy which prioritises "categories of homeopathic products that could pose a higher risk to public health, including those with particular ingredients and routes of administration, products for vulnerable populations, and products with significant quality issues". The FDA is encouraging stakeholders to review this revised draft guidance and submit comments on it during a new public comment period. Final guidance is expected to provide transparency on the categories of homeopathic products that will be prioritised under the risk-based enforcement approach. In addition, the FDA is withdrawing the Compliance Policy Guide entitled "Conditions Under Which Homeopathic Drugs May be Marketed," which is inconsistent with the risk-based approach to regulatory and enforcement action and does not reflect current thinking. The FDA has issued over ten warning letters in 2019 to companies producing homeopathic products for violations of good manufacturing practice regulations or other violations, including warning letters to companies which have manufactured or packaged eye drops in nonsterile conditions. Healthcare professionals and consumers are encouraged to report adverse events or quality issues related to the use of homeopathic products to the FDA’s MedWatch Adverse Event Reporting program. FDA. Statement on the agency’s efforts to protect patients from potentially harmful drugs sold as homeopathic products. Internet Document : 24 Oct 2019. Available from: URL: https://www.fda.gov/news-events/press-announcements/statementagencys-efforts-protect-patients-potentially-harmful-drugs-sold-homeopathic803432282 products
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Reactions 9 Nov 2019 No. 1778
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