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    Four homeopathic injectable producers warned by FDA

    The US Food and Drug Administration (FDA) issued warning letters to four companies marketing unapproved homeopathic injectable drugs on Tuesday, noting specific concerns about the potential for public harm from their products.   “The FDA’s drug approval requirements are designed to protect patients by ensuring, among other things, that drugs are safe and effective for their intended uses. These unapproved injectable drugs are particularly concerning because they inhere...
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    FDA Warns Five Homeopathic Product Manufacturers for GMP Violations

    The US Food and Drug Administration (FDA) on Tuesday released warning letters sent to five homeopathic product manufacturers because of significant good manufacturing practice (GMP) violations. For instance, four of the companies jointly manufacture and package Puriton Eye Relief Drops, which are labeled as homeopathic. But FDA said it tested multiple samples and found the eye drops were non-sterile, which could lead to an eye infection, and had a high pH level, which c...
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    FDA Plots New Enforcement Approach for Homeopathic Products

    The US Food and Drug Administration (FDA) on Monday released new draft guidance outlining how it will take a new risk-based enforcement approach to drug products labeled as homeopathic. The agency says it will begin prioritizing enforcement actions against such homeopathic products with reported safety concerns, intended for preventing or treating serious or life-threatening diseases and products aimed at vulnerable populations, among others. However, without new Co...
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    Asia Regulatory Roundup: India Introduces Tougher Regulations on Homeopathic Medicines (20 November 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Australian Generic Medicine Work-Sharing Trial Misses Completion Target A work-sharing group involving Australian regulators has reported the results of its first collaborative assessment of a generic medicine. The review of the filing took about nine months, four months longer than the collaborators had targeted at the start of the project. Officials from Australia’...
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    House Bill Seeks to Add Mandatory Drug Recall Authority to FDA’s Arsenal

    Rep. Rosa DeLauro (D-CT) on Thursday introduced a new bill that will allow the US Food and Drug Administration (FDA) to do what many assume it already can: Require pharmaceutical or over-the-counter drug companies to stop marketing unsafe products. The Recall Unsafe Drugs Act would give FDA mandatory recall authority over drugs and homeopathic products. The agency confirmed to Focus that it does not have that authority. The loophole is problematic in that some compani...
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    FTC Plans Crackdown on Marketing Claims of OTC Homeopathic Drugs

    The Federal Trade Commission (FTC) on Tuesday announced a new enforcement policy that will hold efficacy and safety claims for OTC homeopathic drugs to the same standard as other products making similar claims. The policy was informed by an FTC workshop held last year to examine how such drugs are marketed to consumers. The FTC also released its  staff report on the workshop , which summarizes the panel presentations and related public comments in addition to describing...
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    FTC Asks FDA to Reevaluate Framework for Homeopathic Products

    The US Food and Drug Administration (FDA) recently announced it was considering changing the way homeopathic products are regulated and asked for input on whether its current regulatory framework for homeopathic products was sufficient. Now, the Federal Trade Commission (FTC) is weighing in, calling on FDA to "consider amending or repealing its framework for homeopathic medications." Background In March 2015, FDA announced a public hearing to evaluate its regul...
  • Diploma Mill Peddled Homeopathy Product as Flu Prevention Method, FDA Claims

    US regulators frequently send warning letters to all sorts of companies for alleged violations and deficiencies; everyone from drug and device manufacturers, to institutional review boards, to small supplement manufacturers. But rarely, as the US Food and Drug Administration (FDA) did last week, do they send one regarding homeopathy products or to an online diploma mill-an unusual combination if there ever was one. Background Homeopathic products are usually just wate...