Next Stop Congress

Summary of Today’s Episode:

Hello, I’m Paola Brown, president of Americans for Homeopathy Choice, back with you for another Insider report about what’s going on in the world of homeopathy. From now on I will be coming to you once a month with a three- to five-minute report that summarizes important developments in the fight to protect homeopathy and also information that will help you explain the role of homeopathy in health care to others.

So, let’s get started.

As many of you know the FDA finalized its guidance on homeopathy in December. Though the FDA claims that the guidance is just a summary of the Agency’s current thinking on homeopathy and not a regulation or law, any company that defies the FDA’s guidance is likely to find itself facing enforcement action—action that could take products off the market and even bankrupt the company.

It should be no surprise then when I tell you that the guidance is creating lots of confusion and uncertainty for consumers and the industry. What IS clear is that homeopathy remains in jeopardy as long as the FDA’s guidance document continues to be the basis for regulating homeopathy in America.

That’s why we at Americans for Homeopathy Choice Action, our legislative arm, are now pressing Congress to take action that will protect our access to the full range of homeopathic medicines while ensuring the safety of homeopathic products.

Our first step is to ask Congress to write into this coming year’s budget a prohibition against using any funds appropriated for the FDA to withdraw products simply because they now fall into the category of “unapproved new drugs” which are being “illegally marketed.” 

You and I know that homeopathic medicines are not new and have been legally recognized as a form of medicine since 1938. But the FDA has designated all homeopathic medicines as “unapproved new drugs” under the guidance which means our medicines can be removed from the marketplace without notice at any time for any reason or no reason at all except that they are “unapproved new drugs.”

Our proposed small addition to the appropriations bill would force the FDA to state a real reason such as contaminated or improperly labeled products for which they would have to provide evidence. The Agency couldn’t just say a homeopathic product is an “unapproved new drug” and pull it off the market without having to show there’s a safety or labeling problem.

 And, don’t think they won’t do this because they already have!

Our second step is to introduce legislation to modernize the law in order to provide a consistent, clear and stable legal framework for homeopathic medicines that serves both consumers and industry well. This legislation is the real solution to protecting homeopathic medicines for the long run.

We are putting together our ideas for what that legislation should look like. We are looking very closely at what Canada has done to regulate homeopathy and we are very impressed. I’ll be talking more about our proposal in future Insider reports.

Thanks for listening. I look forward to seeing you again soon with another Homeopathy Choice Insider report.