With yet another sign that we’re spiraling down the slippery slope toward a dictatorship, the FDA has apparently decided that all homeopathic drugs are illegal. They haven’t yanked them off the market… yet. But this latest development brings that absurd possibility closer to reality than ever before.
Why do I say this? Because the agency recently released a new guidance document — essentially, a statement of their official position on homeopathic drug regulation. And I can’t say I’m the least bit surprised by its contents, which of course, present homeopathic remedies as potential public health menaces.
You know… the type of drugs that hardly ever harm anyone. The drugs that come with virtually no side effects — in stark contrast to prescription medications, all of which happen to bear the FDA’s seal of approval.
Yes, the same FDA that stands idly by as pharmaceuticals claimed the position as the sixth leading cause of death in the United States. The same FDA that watches while millions of Americans lose their lives, literally and figuratively, to prescription opioids.
What a sad, twisted state of affairs…
But I digress. I’ll attempt to swallow my outrage long enough to tell you exactly what these shameless hypocrites had to say.
Some relevant highlights: For starters, it proposes that any homeopathic drug not currently “generally recognized as safe and effective” (GRAS/E) be classified as a new drug. The issue, of course, is that the FDA hasn’t granted any homeopathic drugs GRAS/E status.
Technically speaking, this means that in order to be marketed in compliance with this new guidance, all homeopathic drugs would have to go through the FDA’s formal approval process. And, well… the homeopathy industry simply doesn’t have nearly enough money or resources to invest in clinical research of this caliber.
If this isn’t the opening shot of an FDA war on the homeopathy product market, then what, exactly, is it? This guidance effectively raises the regulatory hammer — the only question now is when and where that hammer will fall.
The FDA insists that they’ll be limiting their enforcement efforts to targets meeting certain high-risk criteria. This would include:
- Products with reported safety concerns
- Products featuring ingredients linked to significant safety concerns
- Any product not administered orally or topically (e.g. injections)
- Products intended as treatments for serious conditions, like cancer or heart disease
- Products designed for children
- Products that don’t meet official standards of quality, strength, or purity
At first glance, very little about this list appears to be objectionable. And the FDA concedes that many homeopathic drugs don’t fall into the above categories. It also claims that it has no intention of taking action against products that don’t raise these flags.
But the writing is on the wall here. If their current position translates into policy, the FDA will have free rein to go after any homeopathic drug currently on the market.
Of all the fights they could be picking, this is by far one of the most needless. It’s true that up to this point, homeopathic drugs haven’t been subject to the FDA’s New Drug Approval processes. But they are beholden to rigorous industry standards — including approval from the Homeopathic Pharmacopoeia of the United States.
And despite what the FDA would have you believe, that does involve clinical evidence of efficacy. Let’s not forget that these homeopathic medications directly compete with pharmaceutical drugs, profits from which go directly toward buying influence with the FDA.
This is a hit job, pure and simple. And you know what’s coming next: nutritional supplements.
I can’t tell you to not be afraid, because you should.
But in the meantime, it’s important to do what you CAN to stay healthy. Eat Mediterranean-style diet (as recommended in my latest book, The A-List Diet) and stock up on your nutritional supplements… while you still can.