TITLE: FDA Declares All Homeopathic Drugs Illegal Threatening Remedies for Millions of Americans
SENTENCE 1: 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.
SENTENCE 2: 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 the law.
SENTENCE 3: The FDA also says that it recognizes that many homeopathic drugs fall outside of these categories and does not intend to take action against such products at this time, but the writing is on the wall.

Bias label: none
Annotator rationales: