FDA: All Homeopathic Drugs Illegal
[link to healthimpactnews.com]
In the guidance, the FDA says:
Any homeopathic drug that has not been considered “generally recognized as safe and effective” (GRAS/E) is considered a new drug;
FDA has not determined that any homeopathic drugs are GRAS/E;
A new drug cannot be marketed unless it goes through the FDA’s approval process;
No homeopathic drugs have gone through FDA approval nor can any producer afford to take them through the approval process.
That’s right: in one fell swoop, the FDA has declared that virtually every single homeopathic drug on the market is being sold illegally. The guidance explains that the agency will apply a risk-based regulatory approach that will prioritize enforcement actions against:
products with reported safety concerns;
products that contain or claim to contain ingredients associated with potentially significant safety concerns, e.g., belladonna or strychnine;
products for routes of administration other than oral and topical, e.g., injectable and ophthalmic products;
products intended to be used for the prevention or treatment of serious and/or life-threatening diseases and conditions, e.g., cancer, heart disease and opioid addition;
products for vulnerable populations, e.g., children; and
products that are deemed adulterated under FDC Act § 501, e.g., do not meet standards of quality, strength or purity as required under
Came across this article , not really sure if it pertains to Emesyl but i thought id share to see what everyone thinks ... Also fairly sure that i read Emesyl did go through the process if so were in the money ... JMO
