Medical Advertising Claims

The Food & Drug Administration (“FDA”) regulates cancer drugs and devices, both for use by humans and pets. Such drugs and devices must obtain FDA approval or clearance before they can be marketed or sold to consumers, so that the FDA can ensure each product is safe and effective for its intended use. The FDA is concerned about the marketing and selling of products that have not been approved, particularly because such products may contain dangerous ingredients or may cause harm by negatively impacting beneficial treatments. Often such products are advertised as “natural” or are labeled as a dietary supplement, which may be a tip-off to consumers that the products have not been approved by the FDA.

cancer pic
Copyright: tashatuvango / 123RF Stock Photo

The FDA has identified the following advertising phrases as “red flags” that may signify a fraudulent product:

  • Treats all forms of cancer
  • Miraculously kills cancer cells and tumors
  • Shrinks malignant tumors
  • Selectively kills cancer cells
  • More effective than chemotherapy
  • Attacks cancer cells, leaving healthy cells intact
  • Cures cancer

Additionally, the FDA has stated that the following catch phrases should tip-off consumers to a potentially bogus health-related product:

  • One product does it all
  • Personal testimonials
  • Quick fixes
  • “All natural”
  • “Miracle cure”
  • Conspiracy theories

In April, the FDA sent 14 warning letters to companies that it determined were making fraudulent claims on their websites related to purported cancer treatments. Fraudulent claims are those that deceptively promote a product as effective against a specific condition—in this instance, cancer—that has not been scientifically proven to be safe and effective for its claimed purposed. According to the FDA, if the companies to which it sent letters do not comply with its warnings, the FDA may take further legal action in order to ensure that such products do not reach consumers.

The FDA requests that consumers avoid use of potentially unsafe or unproven products and to discuss any cancer treatments with their healthcare providers (or, in the case of pets, with their veterinarian and veterinary oncologist). As always, companies that market or sell products requiring FDA approval should ensure that such products are fairly advertised, are properly labeled, are effective and safe for their intended use, and are indeed approved as required.

One likely result is that companies will get sued by its competitors. Such a lawsuit will cost money to defend, cause a distraction to the company, and has the potential to embarrass the company with consumers.

Another potential result is more troubling – an enforcement action by the FTC. Such actions, like competitor lawsuits, are expensive to defend, cause distraction, and have the added problem of communicating to consumers that the government thinks the company is making false statements.

A recent FTC enforcement action decision reinforces the necessity for companies to validate the advertising claims made about their products, particularly if such claims relate to health benefits.

In May 2015, the FTC filed a lawsuit against COORGA Nutraceuticals Corporation and its owner claiming that the Defendants violated the law in claiming that their “Grey Defense” dietary supplements reversed or prevented gray hair. The United States District Court for the District of Wyoming recently granted summary judgment in favor of the FTC, issued an injunction against the company and its owner, and asked the Defendants to pay nearly $400,000.

COORGA marketed Grey Defense to consumers as not only a product that could stop, reverse and prevent the natural graying of hair, but also that it was scientifically proven to do so. The Court found that the COORGA did not have the required scientific evidence to support such claims.  In addition to finding that the company was liable, the Court also found the owner liable because he controlled COORGA’s advertising.  The Court took COORGA’s owner to task for “arrogantly” relying on internet research to validate the company’s claims.  The Court found that this conduct constituted “reckless indifference” and issued an injunction against the company relating to advertising claims across a broad range of products in addition to finding Defendants liable for $391,335.

As this and other FTC enforcement cases make clear, a company must ensure that if it makes scientific claims about its products that it has the testing to back up those claims.

The FTC has long required that if an advertiser makes a specific, verifiable claim, the advertiser needs to have adequate substantiation for the claim before it is made. One of the more interesting and recognizable examples of this rule came on December 1, 2015, when the FTC announced a proposed settlement with Tommie Copper for its claims that its products—copper-infused compression clothing—relieve pain.  Tommie Copper’s advertisements claimed that its copper-infused compression clothing provides pain relief from a number of conditions.  In fact, the company proclaimed that its products provide pain relief comparable to, or better than, drugs or surgery.  For example, its infomercials featured Montel Williams declaring “Tommie Copper truly is pain relief without a pill.”  The advertisements also claimed relief from chronic pain and pain caused by multiple sclerosis, arthritis, and fibromyalgia, relying on some purported customer testimonials.

Copyright: dolgachov / 123RF Stock Photo (Not actually Tommie Copper apparel)

But, based on the 2015 proposed settlement, it appears that Tommie Copper did not have much support for these lofty claims.

The settlement, which will cost Tommie Copper at least $1.35 million, served as a reminder that before making any advertising claim, the advertiser must have adequate substantiation for the claim.  And the bar is higher for medical claims.  As the proposed settlement explains, before the company can make health-related claims related to chronic or severe pain, diseases, drugs, and surgery, it must have “competent and reliable scientific evidence” to support the claims.  FTC v. Tommie Copper, Inc., 7:15-cv-09304-VB, Dkt. 4-1 (S.D.N.Y. Dec. 1, 2015).

The proposed settlement specifically defined “competent and reliable scientific evidence” as “human clinical testing . . . based on standards generally accepted by relevant medical experts” that is “(1) randomized, double-blind, and placebo-controlled; and (2) . . . conducted by researchers qualified by training and experience to conduct such testing.”  Id.  The proposed settlement also prohibits the use of other health-related claims without substantiation from tests, analysis, research, or studies conducted by qualified persons in a manner that is generally accepted in the profession to be accurate and reliable. Id. The monetary judgment in the proposed settlement is a whopping $86.8 million, although Tommie Copper need only pay $1.35 million now.  The remainder of the judgment is suspended based on, among other things, the company’s representations regarding its finances.

Though the facts and circumstances of every advertisement will determine what amount and type of substantiation is required, this settlement shows the FTC will require “competent and reliable scientific evidence” when making health-related claims to consumers.