About 5 million U.S. adults and 1 million U.S. children use homeopathy every year, and the remedies are known to be “generally safe and unlikely to cause severe adverse reactions,” according to the U.S. National Institutes of Health’s National Center for Complementary and Integrative Health. Yet, if the U.S. Food and Drug Administration (FDA) continues on its latest crusade, this natural health modality may soon be much harder to come by.
In a draft guidance document released in December 2017, the FDA takes aim at homeopathic remedies, or as they put it, “drug products labeled as homeopathic.” In a reversal of a long-standing decision to treat homeopathic remedies differently from other drugs, the FDA has now labeled virtually all of these products as “new drugs” that are “subject to FDA enforcement action at any time.”
While deaths from drugs like opioids are now a public health crisis, homeopathy has maintained a much lower, and presumably safer, profile. Yet, the FDA is using its limited resources to target the latter, citing a need to “protect consumers who choose to use homeopathic products.” Why now? The FDA also cited a “large uptick in products labeled as homeopathic that are being marketed for a wide array of diseases and conditions,” to the extent that homeopathic products are now a close to $3 billion industry.
Perhaps that’s $3 billion too much for Big Pharma, FDA’s cozy partner in crime. “[I]n one fell swoop, the FDA has declared that virtually every single homeopathic drug on the market is being sold illegally,” the Alliance for Natural Health USA (ANH USA) wrote — and it’s not an exaggeration. In essence, the FDA’s guidance reads:
- 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….