The U.S. Food and Drug Administration (“FDA”) requests that consumers report any issues they experience with FDA-regulated products so that the FDA can further protect the public health. But it isn’t always clear which products the FDA regulates and which products it doesn’t. Generally, the FDA regulates the following product categories: certain foods, drugs, biologics, medical devices, electronic products that give off radiation, cosmetics, veterinary products, and tobacco products. Within each category is a number of products subject to the FDA’s regulatory authority. A more detailed, though non-exhaustive, list of the products the FDA regulates can be found on the FDA’s website. According to the FDA, these products account for about one-fifth of annual spending by U.S. consumers.

FDA
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The FDA is committed to ensuring that the products it regulates are safe, effective, and correctly labeled. But the FDA does not pre-approve for safety and effectiveness all of the products it regulates before such products can be marketed and sold. For example, the FDA does pre-approve new drugs, biologics, and certain medical devices, but does not pre-approve cosmetics (with the exception of certain color additives) or dietary supplements (though a notification is required for those containing a new dietary ingredient). However, the FDA requires that cosmetics, dietary supplements, and other products be safe for their intended use and be properly labeled/advertised. Accordingly, for such products that the FDA does not pre-approve, the FDA still has regulatory authority to take action when a safety issue arises. With respect to tobacco products, the FDA does not regulate safety in the same way as with other products, as the FDA views tobacco use as a major threat to public health. Notably, last year, the FDA finalized a new rule extending its regulatory authority to all tobacco products, including e-cigarettes, and restricting youth access to such products.

As always, companies should ensure that they products they market and sell are safe for their intended use, are properly labeled, and are fairly advertised. One form of advertising that has caught the FDA’s attention is the phrase “FDA Approved.” The FDA’s recently-updated explanation on what it does and doesn’t approve (and under what circumstances) can be found on the FDA’s website. The FDA’s website also contains detailed information for companies that market and sell FDA-regulated products, including the ability to search for guidance documents that describe the FDA’s interpretation on various regulatory issues and the ability to submit questions regarding the FDA’s policies, regulations, and regulatory process.

Made in the USA Banner
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In the last two months, the Federal Trade Commission (“FTC”) has reached two settlements related to complaints it initiated against companies regarding “Made in the USA” advertising claims.

First, in February, the FTC announced that it had reached a settlement with a Georgia-based water filtration systems company named iSpring Water Systems, LLC.  According to the FTC, iSpring advertised its water filtration systems on its website and through third parties as “Built in USA” (and other similar claims).  The FTC found such advertising false or misleading because the water filtration systems were either entirely imported or contained significant parts that had been imported, thus violating the FTC’s long-standing requirement that “all or virtually all” of the product be made in the USA in order to be advertised as such.  The settlement allows iSpring to make certain qualified claims, with a clear and conspicuous disclosure, but prohibits iSpring from advertising contrary to the FTC’s “all or virtually all” requirement.  More information regarding the settlement is available on the FTC’s blog.

Second, earlier this month, the FTC announced that it had reached a settlement with a Texas-based pulley company named Block Division, Inc.  According to the FTC, Block Division advertised its pulleys in various media using “Made in USA” text and graphics.  The FTC found such advertising misleading given that the pulleys had significant and essential parts that had been imported.  Further, some of the pulleys contained steel plates stamped as “Made in USA” before they were imported.  The settlement allows Block Division to make certain qualified claims, again with a clear and conspicuous disclosure, but prohibits Block Division from advertising contrary to the FTC’s “all or virtually all” requirement.  More information regarding the settlement is available on the FTC’s blog.

Both of these FTC actions and resulting settlements demonstrate that the FTC takes “Made in the USA” claims seriously and will enforce its requirements regarding such advertising.  A prior blog post outlines those requirements in more detail.

In April 2016, the FTC filed a Complaint against Dr. Joseph Mercola and his companies alleging that their indoor tanning system advertisements violated section 5(a) of the FTC Act, which prohibits unfair or deceptive practices in commerce, and section 12(a) of the FTC Act, which prohibits the dissemination of false advertisements in commerce for the purpose of inducing the purchase of foods, drugs, devices, services, or cosmetics.  According to the FTC, indoor tanning systems qualify as “devices” under the FTC Act.

tanning bed
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In its Complaint, the FTC alleged that the defendants disseminated a number of false, misleading, deceptive, and unsubstantiated advertisements on the Mercola.com website, in search engine advertising, in a YouTube video of Dr. Mercola himself, and via newsletters.  Such advertisements include:

  • Tanning with Mercola brand indoor tanning systems is safe;
  • Tanning with Mercola brand indoor tanning systems will not increase the risk of skin cancer as long as consumers top using the system when their skin is only the slightest shade of pink and not burned;
  • Tanning with Mercola brand indoor tanning systems does not increase the risk of skin cancer, including melanoma skin cancer;
  • Tanning with Mercola brand indoor tanning systems reduces the risk of skin cancer;
  • The FDA has endorsed the use of indoor tanning systems as safe;
  • Research proves that indoor tanning systems do not increase the risk of melanoma skin cancer;
  • Certain Mercola brand tanning systems will pull collagen back to the surface of the skin, increase elastin and other enzymes that support the skin, fill in lines and wrinkles, and reverse the appearance of aging;
  • Tanning with Mercola brand tanning systems provides various benefits to consumers, including increasing Vitamin D and providing Vitamin D-related health benefits; and
  • The Vitamin D Council recommends Mercola brand tanning systems (without disclosing that the defendants arranged for the Vitamin D Council to be compensated for its endorsement).

Today, the FTC announced that, as a result of a settlement agreement reached with Dr. Mercola and its companies, the FTC is mailing $2.59 million in refunds to more than 1,300 purchasers of Mercola indoor tanning systems. According to the FTC, the average refund check is $1,897.  Additionally, under the settlement agreement, the defendants are banned from selling indoor tanning systems in the future.

More information regarding the FTC’s views on indoor tanning advertising can be found on the FTC’s website and blog.  According to the FTC, no government agency recommends indoor tanning and the FDA requires indoor tanning equipment to contain signs warning users of the risk of cancer.  In addition, the FTC actively investigates false, misleading, and deceptive advertisements related to indoor tanning.

This morning, the United States Supreme Court heard the long-anticipated oral argument in the Lee v. Tam trademark dispute. The issue in the case, as reported on the SCOTUS blog, is as follows:

“Whether the disparagement provision of the Lanham Act, 15 U.S.C. 1052(a), which provides that no trademark shall be refused registration on account of its nature unless, inter alia, it ‘[c]onsists of . . . matter which may disparage . . . persons, living or dead, institutions, beliefs, or national symbols, or bring them into contempt, or disrepute’ is facially invalid under the Free Speech Clause of the First Amendment.”

Supreme Court
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Stated more simply, the issue facing the Supreme Court is whether section 2(a) of the Lanham Act, which bars the registration of disparaging trademarks, is constitutional. The Supreme Court is now primed to make that decision, which will not only have an impact on the Lee v. Tam dispute but also the Washington Redskins dispute and many others.

In making that decision, the justices will consider the parties’ oral argument and briefing as well as the numerous amicus briefs filed by numerous third party organizations and individuals interested in the outcome of the Lee v. Tam dispute. Demonstrating the significance of this dispute, numerous of the justices during oral argument today asked pointed questions to the attorneys representing the parties, particularly to the attorney arguing on behalf of the United States Patent and Trademark Office (in favor of the Lanham Act’s current prohibition). Today’s oral argument started and ended with questions related to differences in trademark law and copyright law and included questions on a whole range of topics relevant to section 2(a), its constitutionality, and its implications.

The Supreme Court will issue an order in the case later this year. Additional background regarding this dispute and the related Washington Redskins dispute can be found in prior blog posts as part of this blog’s ongoing coverage of developments in this landmark dispute.

Sunscreen
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Earlier this month, the Federal Trade Commission (“FTC”) issued a decision against California Naturel, Inc. related to its advertising of “all natural” sunscreen on both its website and the product packaging itself. On its website, California Naturel was not only advertising its sunscreen as “all natural” but was describing the sunscreen as containing “only the purest, most luxurious and effective ingredients found in nature.” The FTC found that this advertising conveyed that California Naturel’s sunscreen contains only ingredients that are found in nature.  But because California Naturel admitted that eight percent of its sunscreen formula consists of a synthetic ingredient, the FTC determined that California Naturel’s advertising constituted false and misleading advertising and that such advertising is likely to materially impact consumers’ purchasing decisions.

In response to California Naturel’s arguments, the FTC decided that the product’s ingredient list and the disclaimer on California Naturel’s website were insufficient to cure the deceptive advertising. With respect to the ingredient list, the FTC noted that the synthetic ingredient was buried within a list of over 30 ingredients and that nothing identified the ingredient at issue as synthetic. With respect to the website disclaimer, the FTC found that it was not prevalent enough given its location at the bottom of the website—particularly in contrast to the prevalence of the “all natural” advertising elsewhere on the website and on the product packaging itself.

Under its authority to issue a remedy for false and misleading advertising, the FTC issued an order prohibiting California Naturel from advertising its products as “all natural” or making other similar representations. More information about the FTC’s decision against California Naturel can be found here.

The ongoing battle before the United States Supreme Court regarding the ability to register disparaging trademarks, prior details of which can be found in earlier blog posts here, here, and here, is heating up with a recent flurry of amicus brief filings. Earlier this month, the USPTO filed its opening brief in the case involving the rock band The Slants pending before the Supreme Court, urging the Court to uphold section 2(a) of the Lanham Act, the section that bans the registration of disparaging trademarks, and explaining why it believes the ban is not a restriction on free speech. Following that submission, numerous other groups have filed amicus briefs taking various positions on the issue.

The Native Americans who petitioned to cancel the Washington Redskins’ trademark registrations filed an amicus brief in favor of the USPTO’s position and arguing that there is no right under the First Amendment to use a disparaging trademark to silence others. Other Native American organizations also filed an amicus brief asking the Supreme Court to rule in favor of the USPTO and find section 2(a) of the Lanham Act constitutional in light of the government’s incentive to discourage discriminatory conduct. A collection of bar associations filed an amicus brief seeking the same result. The Washington Redskins, on the other hand, are expected to file an amicus brief arguing the opposite–in favor of allowing registration of allegedly disparaging trademarks.

American Bar Association Stamp
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The American Bar Association (“ABA”) filed a procedurally interesting amicus brief, in which it declined to take a position on whether section 2(a) of the Lanham Act is constitutional and instead focused on a procedural issue. The ABA argued that if the Supreme Court holds that disparaging marks are not registerable (i.e. that section 2(a) is constitutional), it should also hold that such marks are still enforceable under the common law and the federal unfair competition provision of the Lanham Act. The ABA believes that the Federal Circuit’s underlying decision is too vague on this point and that it should be clarified at the Supreme Court level. Were the Supreme Court to follow the ABA’s thinking, the implication may be that trademark users (including The Slants and the Washington Redskins) continue to use disparaging marks but rely upon common law protection or federal unfair competition protection for enforcement purposes.

Other amicus briefs have also been filed with the Supreme Court and can be read on the SCOTUS blog website.  The Slants’ brief is forthcoming, and a decision from the Court is not expected until next year.

The U.S. Olympic Committee, like many other major sports organizations, does not shy away from enforcing its trademarks. In addition to enforcing use of the words “Olympic,” “Olympics,” and “Olympiad” and any use of the interlocking rings logo, the Olympic Committee also enforces the use of names and years in the particular convention used by the Olympics (e.g. “Sochi2014” or “Rio2016”).  For example, last year the Olympic Committee sued an individual who had registered 177 websites using the Olympic Committee’s naming convention.  In addition, the Olympic Committee aggressively pursues users of its naming convention and other trademarks as hashtags on social media websites (such as #Rio2016 and #TeamUSA).  This year, a Minnesota company who sought to post about the 2016 Olympics on social media pages filed a declaratory judgment against the Olympic Committee in an attempt to assert its right to do so.  That suit has not been resolved and has instead been plagued by a recent procedural dispute.

Although the Olympic Committee may not always be successful in all of its trademark enforcement efforts, the Olympic Committee shows no sign of letting up. One reason may be that the Olympic Committee has more trademark protection under the Lanham Act than other organizations.  In fact, under the Olympic and Amateur Sports Act of 1978, the Olympic Committee has the exclusive right to use some of its trademarks even where another’s use does not result in a likelihood of customer confusion. This is different than other enforcers of trademarks, who are required to show that another’s use of a trademark (or variation thereof) results in a likelihood of confusion.  Since the Olympic Committee is not required to jump over that particular hurdle, it arguably has a unique ability to enforce certain of its trademarks.

Trademark infringement disputes are not limited to those between for-profit companies.  Indeed, charities also own trademarks and they can and do enforce their trademarks against other organizations (charitable or not) through cease and desist letters, lawsuits, etc.

volunteers with donation
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Case in point:  Last week, Mothers Against Drunk Driving (“MADD”), a non-profit founded in 1980, sued the founders of a relatively new charity, Mothers Of Drunk Drivers (“MODD”), for trademark infringement and dilution of MADD’s trademarks and service marks.  MADD’s complaint, filed in the District of South Carolina, claims that MODD’s use of the marks MOTHERS OF DRUNK DRIVERS and MODD is confusingly similar to MADD’s federally-registered MOTHERS AGAINST DRUNK DRIVING and MADD marks and that the MADD and MOTHERS AGAINST DRUNK DRIVING marks are famous in South Carolina and throughout the United States.  Among other claims, MADD’s complaint also asserts a cybersquatting claim based upon MODD’s use of the domain name mothersofdrunkdrivers.org.

MADD claims that MODD’s actions have injured MADD’s fundraising efforts and goodwill and that any money MODD’s founders have raised due to their use of confusingly similar marks is money that could have gone to MADD to support MADD’s mission.  MODD’s gofundme.com page, attached as an exhibit to MADD’s complaint and available online, indicates that MODD has raised $555 in 5 months.  In terms of damages, MADD seeks to recover all revenues and charitable contributions raised by MODD’s founders as a result of their claimed unlawful conduct.  In addition to damages, MADD seeks an order enjoining MODD’s founders from using the MOTHERS OF DRUNK DRIVERS and MODD marks, requiring the destruction of any marketing materials containing such marks, and ordering the cancellation or transfer of the mothersofdrunkdrivers.org domain name.

Today the Supreme Court announced that it will not hear the Washington Redskins’ trademark dispute, despite the fact that the Supreme Court announced last week that it will hear the related trademark dispute involving the rock band, The Slants.  As referenced in an earlier blog post, the Washington Redskins filed a request last spring asking the Supreme Court to hear its case even though the case is currently pending before the Fourth Circuit.  Although the Supreme Court rejected the Redskins’ request, it is likely that the Supreme Court’s decision regarding The Slants will impact the Redskins’ dispute as well.

rock band illustration
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This morning, the United States Supreme Court granted certiorari to hear the trademark dispute involving the rock band, The Slants.  The United States Patent and Trademark Office (“USPTO”) previously denied The Slants’ trademark registration on the basis of section 2(a) of the Lanham Act, which prohibits the registration of disparaging trademarks.  In 2015, the Federal Circuit held that section 2(a) is itself an unconstitutional restriction on the right to free speech guaranteed by the First Amendment.  The USPTO appealed that decision to the Supreme Court earlier this year, and the Supreme Court announced today that it will hear the case, thus signaling that it will determine whether or not the Lanham Act’s prohibition on offensive trademarks is constitutional.

An earlier blog post described the related dispute over whether the Washington Redskins will lose their federally-registered trademarks in the Redskins name.  The Supreme Court has not indicated whether it will also hear the Redskins’ dispute, which is currently pending before the Fourth Circuit.  However, the Supreme Court’s decision regarding The Slants will very likely impact the Redskins’ dispute as well as the USPTO’s registration of other potentially disparaging trademarks.