It was almost three years ago, in April of 2015, that the Food and Drug Administration (FDA) announced it was reconsidering the way it regulates homeopathic products. We have been anxiously awaiting its decision, and finally they have published their proposed new guidelines. As with their previous proposals, there is a public comment period. Over this same time period the Federal Trade Commission (FTC) revised their own approach to homeopathy, and even gave a prod to the FDA to do the same.
So how are the new proposals? A move in the right direction, but they do not go nearly far enough. That was pretty much what we expected, and were hoping that it would be at least a significant move to actually regulate homeopathic products.
To understand the SBM position on homeopathy, you have to understand what homeopathy is. Here is a quick primer. Basically, homeopathy is a two-century-old pre-scientific medical system based on magical ideas. The first main pillar of homeopathy is that substances which cause symptoms in high doses will treat those same symptoms in extremely small doses. Often fanciful substances are used based upon silly criteria, such as if you cry when you hear piano music. The second pillar is that by diluting those same substances to an extreme degree, their “essence” is released in the final potion. Often the dilution is so great that essentially none of the original ingredient remains. I like to characterize this process as diluting fairy dust out of existence.
And yes – it is exactly that silly. Homeopathy is not the use of herbs or natural substances, as many in the public falsely believe.
Not surprisingly, when studied in proper double-blind clinical trials, homeopathy does not work. Multiple independent scientific reviews of all the published evidence have concluded that homeopathy does not work for any indication. So, how should such worthless magic potions be regulated by the FDA? Why is this even a question?
The story of the FDA and homeopathy goes back to the 1938 FDA Act. In the 1938 FDA Act, one Senator, Royal Copeland, who was a physician and homeopath, included in the bill that the provision that the Homeopathic Pharmacopeia of the United States (HPUS) would be included in the list of official drugs. The legacy of that one senator survives to today.
For much of the intervening time homeopathy was a small niche market, and the FDA determined that it was not worth its limited resources to actually regulate it. In their proposed changes, however, they acknowledge:
Until relatively recently, homeopathy was a small market for specialized products. Over the last decade, the homeopathic drug market has grown exponentially, resulting in a nearly $3 billion industry that exposes more patients to potential risks associated with the proliferation of unproven, untested products and unsubstantiated health claims.
Now that the market for homeopathic products has exploded – thanks in part to lax FDA oversight – the FDA realizes it has to do its job. They are motivated not just by the fact that homeopathic products are nonsense, but because lax regulations have led to abuse. Companies can label anything as homeopathic as an end-run around FDA oversight. They state:
During this time, the FDA has seen a corresponding increase in safety concerns, including serious adverse events, associated with drug products labeled as homeopathic. In addition, the agency has also found an increasing number of poorly manufactured products that contain potentially dangerous amounts of active ingredients that can create additional risks.
What is the FDA proposing?
The FDA is clearly trying to split the baby in their new proposed approach. By this I mean they want to protect the public from harmful health products, but at the same time respect consumer choice. I understand, politically, why they might feel they need to do that, even though I disagree. I don’t disagree with consumer choice – I disagree that that is the issue. If consumers are offered a completely fraudulent product with zero actual value, that is no choice. There has to be a line somewhere.
The FDA is proposing that they take a risk-based approach. This means they will target homeopathic products that they feel pose the greatest risk to the public. Here are their criteria:
- products with reported safety concerns;
- products that contain or claim to contain ingredients associated with potentially significant safety concerns;
- products for routes of administration other than oral and topical;
- products intended to be used for the prevention or treatment of serious and/or life-threatening diseases and conditions;
- products for vulnerable populations; and
- products that do not meet standards of quality, strength or purity as required under the law.
That is a reasonable list, and I agree that these criteria represent greater risk. It is also perfectly reasonable for an agency like the FDA to prioritize the higher risks first. They further state:
Given the concerns about the proliferation of potentially ineffective and harmful products labeled as homeopathic, the FDA will consider taking additional enforcement and/or regulatory actions, consistent with the current enforcement policies, which also align with the risk-based categories described in the draft guidance, in the interest of protecting the public.
Here is the proposed new guidelines document. It contains only a little more information than the press release. But here is the meat – it is a bit technical, but this is the essence of what they are proposing (in addition to the risk-based approach to priority):
The definition of “drug” in section 201(g)(1) of the FD&C Act (21 U.S.C. 321(g)) includes articles recognized in the HPUS or any of its supplements. As such, homeopathic drugs are subject to the same regulatory requirements as other drugs. Generally, a drug, including a homeopathic drug, is considered a “new drug” if it is not generally recognized as safe and effective (GRAS/E) by qualified experts for use under the conditions prescribed, recommended, or suggested in the labeling (section 201(p) of the FD&C Act) (21 U.S.C. 321(p)). FDA makes GRAS/E determinations for OTC drugs marketed under the OTC Drug Review.4 The FDA has not reviewed any drug products labeled as homeopathic under the OTC Drug Review, because the Agency categorized these products as a separate category and deferred consideration of them. (37 FR 9464, 9466 (May 11, 1972)). Under section 505(a) of the FD&C Act (21 U.S.C. 355(a)), before any “new drug” is marketed, it must be the subject of an approved application filed pursuant to section 505(b) or section 505(j) of the FD&C Act; however, a biological product with an approved license under section 351(a) of the Public Health Service Act (PHS Act) (4272 U.S.C. 262(a)) is not required to have an approved application under section 505 of the FD&C Act. Accordingly, absent a determination that a drug product labeled as homeopathic is not a “new drug” under section 201(p), all drug products labeled as homeopathic are subject to the premarket approval requirements in section 505 of the FD&C Act or section 351 of the PHS Act. There are no drug products labeled as homeopathic that are approved by FDA.
Let me break that down. They are affirming that according to FDA rules, homeopathic products are drugs. They can be regulated as drugs. Up until now the FDA has simply chosen not to actively regulate them, and deferred to the homeopathic industry. But they are putting the industry on notice that they will now actually regulate their products as drugs, based upon the risk-based priority.
They further clarify what it means to be regulated as a drug. There are two ways to get to market. The harder way is to be FDA approved as safe and effective for a specific disease indication. That is the path that requires tens or hundreds of millions of dollars and multiple studies for safety and efficacy. The second path is to be marketed as an over-the-counter drug, which requires being determined to be GRAS/E – generally recognized as safe and effective.
That paragraph further states that no homeopathic products are FDA approved or determined to be GRAS/E. They were simply given a pass up until now.
What all this seems to be saying is that the FDA is putting the industry on notice (if they adopt these proposed new guidelines) that, without specific warning, any drug product labeled as homeopathic can be regulated like any other drug. That means it can be pulled from the market because it is not FDA approved or determined to be GRAS/E. They are prioritizing high-risk products, but these guidelines apply to all drugs labeled homeopathic.
Of course, if they adopt these guidelines, the real test is how they will be enforced. The most optimistic interpretation of these proposed guidelines is that the FDA is preparing to start decimating the homeopathic product industry by systematically taking such products off the market. That would be completely appropriate, and in fact anything less is a dereliction of duty, in my opinion. They plan on starting with high-risk products, but are giving themselves permission, essentially, to work their way entirely through the industry.
The most pessimistic interpretation is that the FDA plans on sending strongly worded warning letters to producers of high-risk homeopathic products asking that they make changes to the product or its marketing so that they will no longer be considered high risk. The reality will likely be somewhere in between, and it remains to be seen where along the spectrum from heroic to pathetic they will fall.
The press release does contain some weasel phrases, such as:
We respect that some individuals want to use alternative treatments, but the FDA has a responsibility to protect the public from products that may not deliver any benefit and have the potential to cause harm.
Let’s hope that the FDA is setting the stage to correct this historic travesty. The FDA is charged, as they acknowledge, with protecting the public from harmful or worthless products. Homeopathic products are all 100% worthless – that is the clear and undeniable scientific consensus. They have the authority to regulated homeopathic products as drugs – all they need is the political will to do so. These are internal guidelines for themselves. There is no new legislation needed. All the FDA has to do is decide to do their job.
Take advantage of the public comment period (90 days from Dec 18th). Let the FDA know that the public they serve wants science-based regulations.