Last month, the Society for Science-Based Medicine submitted a comment to the Food and Drug Administration (FDA) in response to its request for public comments on the agency’s current regulation (actually, lack of regulation) of homeopathic drugs. As the SFSBM pointed out, the FDA has, without legal authority, exempted homeopathic drugs from the safety and efficacy requirements applicable to other drugs under the Food, Drug and Cosmetic Act (FD&C Act). Lax regulation has resulted in consumer confusion: consumers do not understand homeopathy, how the FDA regulates homeopathic drugs, and the lack of scientific evidence underlying claims made by homeopathic drug companies.
As it turns out, we were in excellent company. The Federal Trade Commission (FTC), the agency charged with preventing fraudulent and deceptive business practices, submitted its own comment to the FDA, making these same points. (The FTC is holding its own workshop on advertising homeopathic drugs later this month. We’ll get to that shortly.)
The FTC’s advertising substantiation policy requires that health-related efficacy claims be supported by competent and reliable scientific evidence. The FDA, despite federal law, does not require evidence of efficacy for homeopathic drugs prior to their being marketed. This creates a potential conflict between the two regulatory schemes, resulting in homeopathic over-the-counter (OTC) “drugs” on the market that both comply with FDA’s policy and violate FTC’s policy. This, says the FTC, can be harmful to consumers and create confusion for advertisers. The FTC “recommends that the FDA reconsider its regulatory framework for homeopathic medicines” and tells the FDA what it can do to remedy the situation.
According to the FTC, the FTC’s and FDA’s jurisdiction over OTC drugs overlaps considerably. [The vast majority of homeopathic drugs are OTC.] Since 1971, the two agencies have cooperated in regulating the marketing of OTC products, with the FDA focusing on product labeling and the FTC on advertising. Unfortunately, the FDA’s continued exemption of homeopathic OTC drugs from regulation imposed on all other OTC products has been an impediment to this cooperation and, we might add, greatly enriched the homeopathic drug industry, which has essentially regulated itself, with the blessing of the FDA.
As the FTC points out, in 1972, the FDA deferred homeopathic drugs from a process to determine which OTC drugs were generally recognized as safe and effective if taken as directed. Despite the FDA’s assurances that it would put homeopathic drugs through the same paces, over 40 years later it has not done so. Then, in 1988, the FDA issued a Compliance Policy Guide (CPG 400.400) permitting the manufacture and distribution of homeopathic drugs without FDA approval, thereby institutionalizing the regulatory neglect that had been going on since 1938, when the FD&C Act was passed. (The FTC doesn’t use those exact words, but that is the real effect of CPG 400.400.) Not only does the CPG exempt homeopathic drugs from demonstrating efficacy, it also allows claims that the drug treats specific conditions as long as the conditions are self-limiting and not chronic. As well, the CPG requires an indication for use on the label.
Translation: the entire homeopathic drug label could be a fabrication and the FDA isn’t going to do anything about it.
FDA interferes with FTC regulation
The FTC takes a far different tack in regulating homeopathic remedies, or, at least, it would like to if not for the FDA.
The FTC’s well-established position on advertising substantiation was first announced in 1972 and has been repeatedly reaffirmed. For health, safety, or efficacy claims, the FTC has generally required that advertisers possess “competent and reliable scientific evidence,” defined as “tests, analyses, research, or studies that have been conducted and evaluated in an objective manner by qualified persons and are generally accepted in the profession to yield accurate and reliable results.” Competent and reliable scientific evidence may take different forms depending on the type of claim being made. For some claims, the substantiation required may be one or more well-designed human clinical studies. Neither the FTC Act, nor any FTC rules or policy statement, exempts advertising claims for homeopathic drugs from these standards. [Footnotes omitted.]
Given the lack of evidence of efficacy for homeopathic products, homeopathic advertising should have been doomed by the FTC’s advertising requirements long ago. But the FDA’s slack regulation has not only allowed false labeling, it has prevented the FTC from doing its job. Where the FDA’s and the FTC’s jurisdiction over advertising overlaps, the FTC has been reluctant to pursue homeopathic drug companies because of this conflict.
The FTC’s comment suggests the conflict can be resolved by the FDA taking one of three actions:
- Withdraw CPG 400.400, and make homeopathic drugs subject to the same regulatory requirements as other drug products. [This is the solution advocated by SFSBM. Indeed, we feel this is exactly what Congress has told the FDA to do.]
- Eliminate the requirement that an indication for use appear on the label. [Remember: the FDA requires that a use be indicated but does not require that it be truthful.] If a company wanted to include an indication on the label it could. Of course, without an indication there would be no clue as to what the product is for, and the FTC thinks most companies will include one. If the company does so, however, it will need competent and reliable scientific evidence to comply with the FTC’s advertising rules, even if the FDA continues to exempt homeopathic products from demonstrating efficacy.
- Actually require that any indication appearing on the label be supported by competent and reliable scientific evidence, just as the FTC does.
In addition to the FTC-FDA regulatory conflict, the FTC commented that the CPG could lead to confusion for both consumers and advertisers. We would say, of course, that it does lead to consumer confusion. If the consumer knew the truth, why in the world would he buy a homeopathic product? It also, according to the FTC, creates a loophole allowing manufacturers to skip more stringent requirements by labeling their products “homeopathic.”
Some advertisers may believe that compliance with the FDA’s CPG means they are home free when, in fact, they could be in violation of FTC substantiation requirements. This actually happened in a proceeding involving “Earache Relief Drops,” a homeopathic OTC remedy claiming it “relieves pain, sooths & calms” and is “safe for use with antibiotics.” Of course, the manufacturer did not have competent and reliable scientific evidence that this was actually true, although it is likely correct that the product didn’t interfere with antibiotics due to the fact that homeopathic drugs rarely contain any active ingredient. Indeed, evidence that the product “relieves pain” would have been impossible to produce, given the pseudoscience upon which homeopathy is based. The manufacturer’s defense, when told to produce such evidence, was that it didn’t have to, because the FDA didn’t require it. In fact, the manufacturer was under the false impression that the FTC didn’t require any evidence either.
Evidence of consumer confusion
At the FDA hearing, the homeopathic industry was unable to produce a shred of evidence that consumers understand the true nature of homeopathic drugs. SFSBM’s comment noted the many and varied unproven claims made for homeopathy’s effectiveness in online comments from consumers, including, among numerous others, effectiveness for ADHD, cancer, coma, food poisoning, infertility, various infections, psoriasis and spider bites.
The FTC’s comment brings valuable new information to the FDA’s decision-making: actual research the FTC undertook on consumer confusion. First, the FTC, working with an outside firm, set up small focus groups to inform further research efforts. The information gained was used to formulate a “copy test,” which gauged consumer beliefs about homeopathy based on variations on the product labels. According to the FTC,
our research suggests that a significant percentage of consumers do not understand the nature of homeopathic products, how they are regulated, or the level of substantiation to support claims for those products.
In particular, consumers in the focus groups:
- had difficulty distinguishing between herbal and homeopathic products;
- associated homeopathic products with “natural” or, in a misconception reminiscent of the Food Babe, “non-chemical” products; and
- did not understand how homeopathic remedies are supposed to “work,” and, when told, questioned their effectiveness.
In the copy tests, consumers:
- misconceived the level of evidence required by regulators for various products and mistakenly believed the FDA has approved homeopathic products for efficacy;
- did not understand how homeopathic remedies are supposed to “work,” and, when told, questioned their effectiveness; and
- believed that homeopathic remedy manufacturers tested their products for effectiveness.
The FTC is also concerned by the mingling of conventional and homeopathic products on store shelves, the unusual terminology used in homeopathic product labeling (“it is difficult to understand what 2X means”), and the risk that consumers will chose homeopathic remedies over proven medicine.
I don’t know how often (if ever) one governmental agency recommends that another government agency “reconsider its regulatory framework” because its current policies cause consumer confusion, potential harm, and inhibit the former’s ability to do its job, which happens to be preventing that very same consumer confusion and harm. Any of the FTC’s proposed solutions would effectively kill off the consumer market for OTC homeopathic remedies. (Depending on what the FDA does, prescription homeopathic remedies could possibly escape extinction.) An FDA Law Blog post asked: “Will FTC Kill Homeopathic Products – or Will FDA?” Looks like it will be a joint effort.
FTC workshop on homeopathic drug advertising
The FTC’s September 21 workshop examining advertising of OTC homeopathic products:
will bring together a variety of stakeholders, including medical professionals, industry representatives, consumer advocates, and government regulators.
According to an e-mail I received from the FTC, there will be no speakers, unlike the FDA’s hearing. The FTC’s announcement also:
invites the public to submit research, recommendations for topics of discussion, and requests to participate as panelists. The workshop will cover topics including:
- A look at changes in the homeopathic market, its advertising, and what consumers know;
- The science behind homeopathy and its effectiveness;
- The effects of recent class actions against homeopathic product companies;
- The application of Section 5 of the FTC Act to advertising claims for homeopathic products; and
- Public policy concerns about the current regulation of homeopathic products.
(My own request to be a panelist was, sadly, turned down.)
Based on its comment to the FDA, the FTC appears to have made up its mind on topics 1, 2, 4 and 5. With regard to topic 2, in the FTC’s comment we see hints that it doesn’t seem inclined to accept the homeopathic industry’s fantastical claims as “science” or its flawed methodology (e.g., “provings”) as reliable evidence of effectiveness. When discussing the focus group results, the FTC referred to increased consumer skepticism upon learning “the theory of homeopathy” and “the principles behind it,” suggesting that, without this information, “consumers may choose homeopathic products based on incorrect and incomplete information.” [Emphasis added.] Of course, it should go without saying that no responsible scientist would ever accept homeopathy’s underlying “theories” as competent and reliable scientific evidence. One could become worried, however, when reading the transcript of the FDA’s hearing, where naturopath/homeopath Amy Rothenberg’s statement that homeopathy could be explained by hormesis (among other pseudoscientific explanations) went without further examination by the FDA’s panel.
As to topic 3, there is a recent decision in a class action which may spur the FDA and FTC to act. Prior to the decision, class actions had been allowed to go forward despite the homeopathic companies’ claims that these suits were preempted by federal law, that is, the regulatory scheme already in place for homeopathic drugs. To which the plaintiffs replied: Regulation? What regulation? There isn’t any.
However, a class action was recently brought against Whole Foods in U.S. District Court for the Southern District of Florida, seeking both economic damages and injunctive relief, in the form of an order prohibiting further sale. The products at issue were Whole Foods’ house brand homeopathic remedies. Whole Foods was successful in its preemption defense, which knocked out the claims for injunctive relief. Essentially the court ruled that the plaintiffs were trying to ban a product that the FDA allowed, something the court could not do.
Whole Foods also won on the “primary jurisdiction” issue. This argument was based on the fact that Congress had determined the appropriate forum for deciding the issues raised by the plaintiffs – the labeling of homeopathic drugs – was the FDA, not the courts. Thus, this court must abstain from deciding those issues:
The Food and Drug Administration has the necessary experience and expertise in regulating labeling of homeopathic medication and it is within the Agency’s purview to decide whether the labels are compliant with federal law and the comprehensive regulatory scheme it has devised. . . . In this case, however, given the extensive regulatory scheme to oversee homeopathic drug marketing and the questions presented over the labels in this case, the Court finds abstention appropriate under the primary jurisdiction doctrine.
The court is correct. There is an “extensive regulatory scheme to oversee homeopathic drug marketing.” It’s just that the FDA has chosen to ignore it. Now that one court has declined to grant relief, perhaps the FDA will be further induced to, in the words of the FTC, “reconsider its regulatory framework” and force these fraudulent products off the market.
SFSBM will be submitting a comment to the FTC and we hope you will too. You can find out how here. Comments are due by November 20, 2015. You can find out more about the FTC’s standards for truthful advertising here.
And while you’re at it, send money
Not to the FTC, of course, but to SFSBM. (Sorry for the nonsequitur, but since I had your attention.) Last year, SFSBM’s first year of operations, lots of you enthusiastically joined the fight against pseudoscience by joining SFSBM. But some of you let your renewal date slip past without re-upping this year. So please head over to the SFSBM website and pay your dues, or join for the first time, or just send in some money. (SFSBM is a Section 501(c)(3) tax-exempt organization, so your membership dues and contributions are tax-deductible “to the extent allowed by law. Check with your tax professional.”) While volunteers do much of the work (especially Dr. Crislip), insurance, keeping the website online, software and other necessities require money. No SFSBM, no SFSBM comments to the FTC and FDA on homeopathy. So send some, please. (Money, not homeopathy.) And do it now, before it slips your mind. Thank you.