Homeopathic drugs held to same standards by the FTC

Homeopathic drugs held to same standards by the FTCIn late September 2015, the FTC hosted a one-day public workshop, titled “Homeopathic Medicine & Advertising.”  The workshop explored advertising for over-the-counter (“OTC”) homeopathic drugs.  The workshop included several panel discussions.  The topics explored by the panel discussions touched on issues such as the current state of the homeopathic market, advertising for homeopathic products, consumer knowledge and understanding, evaluation of the scientific support for homeopathy, the application of Section 5 of the FTC Act to the advertising of homeopathic drugs, public policy concerns, and the effects of class actions against the manufacturers of homeopathic products.

FTC Issues Staff Report on Homeopathic Medicine and Advertising Workshop

On the heel of the FTC’s homeopathic workshop, the FTC issued a staff report, detailing the workshop, as well as the FTC’s efforts related to homeopathy.  After summarizing the workshop, the FTC’s staff report details research conducted by the FTC as it relates to homeopathic products.  The FTC’s own research includes focus groups and copy tests.  According to the FTC, “The focus group results … suggested that there is a poor understanding of the principles underlying homeopathic products.”  Many of the adults and parents that participated in the focus groups believed that homeopathic products were akin to natural or home remedies.

When the homeopathic products were properly explained to the participants of the focus groups, members of the focus groups said they would “look[ ] more critically at homeopathic treatments … [in] evaluat[ing] them in comparison to other remedies.”  The copy test results, which were based on answers to a screening questionnaire, “revealed that many consumers mistakenly believed the FDA had approved the homeopathic products for efficacy.”  Additionally, “[t]he copy test results also showed that consumers mistakenly believed that the manufacturers of homeopathic products had tested their products on people in order to show their effectiveness.”

FTC Solicits Public Comments Regarding Homeopathic Drugs

In conjunction with the workshop, the FTC solicited written comments regarding homeopathic products.  In total, the FTC received more than 530 written comments.  Of those 530 comments, “[o]ver 400 consumers wrote to express their positive experiences with homeopathic products.”  Another 30 individual homeopathic practitioners wrote to express “their positive experiences or those of their patients.”  Several other companies or homeopathic manufacturers also submitted favorable comments in regards to the results produced by homeopathic products.  However, “[a]pproximately 50 individuals submitted comments questioning or denouncing homeopathic products.”  A number of these individuals “called on the FTC to subject claims for OTC homeopathic products to the same standards as any other drug. Others called for a prohibition on homeopathic efficacy claims or an outright product ban.”  Furthermore, several scientific organizations submitted comments denigrating homeopathic products.

FTC Concludes That Homeopathic Drugs Should Be Held to Same Standards as Other Drugs

At the end of its staff report, the FTC concluded:

No convincing reasons have been advanced either in the comments or the workshop as to why efficacy and safety claims for OTC homeopathic drugs should not be held to the same truth-in-advertising standards as other products claiming health benefits.  Efficacy claims for traditional OTC homeopathic products are only supported by homeopathic theories and homeopathic provings, which are not accepted by most modern medical experts and do not constitute competent and reliable scientific evidence that these products have the claimed treatment effects.  For these reasons, the vast majority of OTC homeopathic drugs lack adequate substantiation for their efficacy claims.

To address concerns that many consumers are likely being misled by current marketing claims, the Commission is issuing an Enforcement Policy Statement, making clear that marketers of OTC homeopathic drugs must either have adequate substantiation for their efficacy claims or effectively communicate the lack of scientific evidence backing them and that their claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts.  This approach is fully consistent with the First Amendment, does not limit consumer access to OTC homeopathic products, and does not conflict with FDA’s current regulatory stance because it would allow a marketer to include on labeling an indication for use that is not supported by scientific evidence so long as the marketer effectively communicated the limited basis for the claim in the manner described above.

FTC Issues Policy Statement Regarding Enforcement of Homeopathic Drug Claims

Now, more than a year since its workshop, the FTC has released an official policy statement regarding the marketing of homeopathic drugs.  According to the FTC, the policy statement is meant “to provide guidance regarding its enforcement policy with respect to marketing claims for over-the-counter (OTC) homeopathic drugs.”  The FTC says that is policy statement only applies “to OTC products intended solely for self-limiting disease conditions amenable to self-diagnosis of symptoms and treatment.”

The FTC’s policy statement explains that pursuant to sections 5 and 12 of the FTC Act, the FTC has “authority over disease and other health related claims.”  Section 5 applies to product labeling, as well as advertising, and prohibits unfair or deceptive acts or practices in or affecting commerce.  Section 12 prohibits the dissemination of false advertising or labeling of OTC drug products in or affecting commerce of foods, drugs, devices, services, or cosmetics.  In order to comply with sections 5 and 12, “companies must have a reasonable basis for making objective product claims, including claims that a product can treat specific conditions, before those claims are made.”

Homeopathic Drug Held to Same Standard as Non-Homeopathic Drug Claims

In the eyes of the FTC, “homeopathic product claims are not based on modern scientific methods are not accepted by modern medical experts, but homeopathy nevertheless has many adherents.”  Even still, the FTC sets forth in its policy statement that homeopathic products are not exempted from the “general requirement that objective product claims be truthful and substantiated.”  The FTC admits that even though homeopathic products are not exempted, the FTC “has rarely challenged misleading claims for products that were homeopathic or purportedly homeopathic” since 1972 when the FTC announced that objective product claims had to be substantiated.

Regardless of its lack of enforcement efforts, the FTC says that homeopathic products “are held to the same standards as similar claims for non-homeopathic drugs.”  That means that “[a]bsent express or implied reference to a particular level of support, the Commission, in evaluating the types of evidence necessary to substantiate a claim, considers ‘the type of claim, the product, the consequences of a false claim, the benefits of a truthful claim, the cost of developing substantiation for the claim, and the amount of substantiation experts believe is reasonable.’”

Generally, for all health, safety, or efficacy claims, the FTC requires 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 [that] are generally accepted in the profession to yield accurate and reliable results.”  Additionally, “for health benefit claims, particularly claims that a product can treat or prevent a disease or its symptoms, the substantiation required has been well-designed human clinical testing.”

Homeopathic Drug Claims Must be Substantiated, or Must Make Certain Disclosures to Avoid Misleading Consumers

As it relates to homeopathic drugs specifically, the FTC says that for the vast majority of OTC homeopathic drugs, “the case for efficacy is based solely on traditional homeopathic theories and there are no valid studies using current scientific methods showing the product’s efficacy.”  The FTC explains that such traditional theories are not enough to satisfy the requirements of sections 5 and 12 because they “lack a reasonable basis and are likely misleading.”  The FTC does admit that even if a homeopathic product is not properly substantiated by competent and reliable scientific evidence, the advertising or the labeling of the product may not be deceptive if the advertising or product labeling communicates to the consumer that: “(1) there is no scientific evidence that the product works and (2) the product’s claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts.”

FTC Provides Guidance for Homeopathic Drug Disclaimers

In addition to the aforementioned communications to consumers, the FTC notes that “[p]erfunctory disclaimers are unlikely to successfully communicate the information necessary to make claims for OTC homeopathic drugs non-misleading.”  As a result, the FTC suggests:

  • Any disclosure should stand out and be in close proximity to the efficacy message; to be effective, it may actually need to be incorporated into the efficacy message.
  • Marketers should not undercut such qualifications with additional positive statements or consumer endorsements reinforcing a product’s efficacy.
  • In light of the inherent contradiction in asserting that a product is effective and also disclosing that there is no scientific evidence for such an assertion, it is possible that depending on how they are presented many of these disclosures will be insufficient to prevent consumer deception. Marketers are advised to develop extrinsic evidence, such as consumer surveys, to determine the net impressions communicated by their marketing materials.
  • The Commission will carefully scrutinize the net impression of OTC homeopathic advertising or other marketing employing disclosures to ensure that it adequately conveys the extremely limited nature of the health claim being asserted. If, despite a marketer’s disclosures, an ad conveys more substantiation than the marketer has, the marketer will be in violation of the FTC Act.

FTC Reiterates That There is no Basis to Treat Homeopathic Drugs Differently Form Other Health Products

At the close of its policy statement, the FTC makes clear that “there is is no basis under the FTC Act to treat OTC homeopathic drugs differently than other health products.”  As a result, “unqualified disease claims made for homeopathic drugs must be substantiated by competent and reliable scientific evidence.”  However, the FTC sets forth that “truthful, nonmisleading, effective disclosure of the basis for an efficacy claim may be possible.”  Or in other words, if homeopathic drug manufacturers are careful, then they may still advertise their products without running afoul of the FTC, even if the product is not substantiated by competent and reliable scientific evidence.

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