On May 20, 2016, the Food and Drug Administration (“FDA”) announced new changes to the Nutrition Facts label required for packaged foods.  The FDA’s intent was to create a new label that would make it easier for consumer to make informed food choices and would reflect new scientific information, such as the link between a consumer’s diet and chronic diseases (e.g. obesity and heart disease).

The FDA set the original compliance deadline for the new Nutrition Facts label as July 26, 2018, with an additional year for small businesses (manufacturers with food sales of less than $10 million annually).  However, on June 13, 2017, following industry and consumer group feedback, the FDA announced that it intended to extend the original compliance deadline so that it could provide manufacturers with necessary guidance, allow manufacturers additional time to complete and print new labels for their products, and minimize the period during which consumers will see both labels in the marketplace.  The FDA has not yet indicated what the new compliance deadline will be, but industry and consumer groups will certainly be watching closely.

Detailed information regarding the new Nutrition Facts label and the FDA’s changes are available on the FDA’s website.  In addition, the FDA has developed a side-by-side comparison of the original Nutrition Facts label and the new Nutrition Facts label, making the FDA’s changes easy to spot.  For example, certain items of information–“servings per container,” “serving size,” and “calories”–will now appear in bigger and/or bolder font.  In addition, the FDA is requiring that “serving size” be updated to more realistically reflect the amount of food customarily eaten at one time, that certain changes be made for certain size packages, and that “daily values” be updated to reflect new scientific evidence.  The FDA is also requiring the addition or removal of certain items of information.  For example, in light of scientific research indicating that the type of fat is more important than the amount, the FDA has removed “calories from fat” from the label entirely.  The FDA has also removed “vitamin A” and “vitamin C” but has added “vitamin D” and “potassium” in recognition of research indicating that the lack of such nutrients is associated with increased risk of chronic disease and is requiring that manufacturers now declare the actual amount of the four required vitamins/minerals in addition to their “daily value.”  As another addition, the FDA is now requiring “added sugars” be declared directly beneath the “total sugars” listing.  The FDA has also modified the list of required nutrients that must be declared at the bottom of the Nutrition Facts label and has updated the footnote to better explain the meaning of “daily value.”

After 20 years with the current Nutrition Facts label, the FDA has determined that change is in order.  How soon that change will ultimately take effect is yet to be determined.

 

This morning, the United States Supreme Court issued its long-anticipated ruling in the Lee v. Tam (now designated Matal v. Tam) trademark dispute involving the rock band, The Slants.  As detailed in an earlier blog post, the legal issue faced by the Supreme Court was whether section 2(a) of the Lanham Act, which bars the registration of disparaging trademarks, is constitutional.

roadsign
Copyright: 72soul / 123RF Stock Photo

Justice Alito wrote the opinion for the Supreme Court, which affirmed 8-0 the Federal Circuit’s prior determination that the disparaging trademark ban is facially unconstitutional under the First Amendment’s free speech clause.  In reaching that conclusion, Justice Alito explained that trademarks constitute private speech, not government speech as the government had argued.  As Justice Alito pointedly and simply stated, “Speech may not be banned on the ground that it expresses ideas that offend.”  Justice Alito’s analysis, other aspects of his opinion joined by a smaller number of justices, and two concurring opinions can be read here.

As noted in an earlier blog post, although the Supreme Court decided to hear the Tam case last year, it decided not to hear the Washington Redskins’ related trademark dispute described in another earlier blog post.  It now seems that the Supreme Court’s decision with respect to The Slants will allow the Washington Redskins to keep their federally-registered trademarks in the Redskins name, despite the United States Patent and Trademark Office’s prior cancellation of a number of those trademarks.  More broadly, the outcome of the Tam case may entitle any trademark registrant to invoke the First Amendment’s free speech clause to register disparaging or offensive trademarks.

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.

The Federal Trade Commission (“FTC”) recently filed a Complaint in the Southern District of California against six entities and four individuals, accusing them of deceiving customers with their use of “free” and “risk-free” trial period advertising related to cooking products, golf-related products, and online subscription services on their websites, in TV infomercials, and via email.

risk-free trial offer
Copyright: kchung / 123RF Stock Photo

The FTC’s Complaint alleges that the defendants violated section 5(a) of the FTC Act, which prohibits unfair or deceptive acts, by misrepresenting the trial offers applicable to their products.  Specifically, the FTC accuses the defendants of advertising their products as having a “risk-free” trial period when, in reality, the consumers are required to return the product at their expense before the trial period ends in order to avoid being charged additional amounts for the product.  The FTC also accuses the defendants of failing to adequately disclose the material terms and conditions of the trial offer, of their continuity/subscription plan offers, and of their refund and cancellation policy.  For example, the FTC takes issue with the defendants’ failure to clearly disclose that they would start charging the consumer if he/she did not cancel the trial period or return the product.

In addition to violations of the FTC Act, the FTC’s Complaint also alleges violations of the Restore Online Shoppers’ Confidence Act (“ROSCA”).  The FTC describes ROSCA as an act that “prohibits any post-transaction third party seller (a seller who markets goods or services online through an initial merchant after a consumer has initiated a transaction with that merchant) from charging any financial account in an Internet transaction unless it has disclosed clearly all material terms of the transaction and obtained the consumer’s express informed consent to the charge.”  The FTC’s Complaint against the defendants focuses on section 4 of ROSCA, which prohibits the sale of products through an improper “negative option” feature.  A “negative option” feature is a provision in an offer to sell goods or services under which the consumer’s silence is taken as an acceptance of the offer.  It is improper to utilize a “negative option” feature unless the seller satisfies the following requirements: (1) clearly and conspicuously disclose all material terms of the transaction before obtaining the consumer’s billing information, (2) obtain the consumer’s express written consent before charging the consumer, and (3) provide a simple mechanism for the consumer to stop recurring charges.  The FTC’s Complaint alleges that, in violation of section 4 of ROSCA, the defendants did not meet any of those three requirements with respect to their cooking and golf-related goods and services.

The FTC seeks an injunction preventing future violations of the FTC Act and ROSCA as well as other relief necessary to redress injury to consumers.  It is clear that the FTC looks closely at advertisements claiming to offer “free” and “risk-free” trial periods and that companies should make sure to adhere to the FTC’s and ROSCA’s requirements.

 

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
Copyright: bakhtiarzein / 123RF Stock Photo

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
Copyright: lifeking / 123RF Stock Photo

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
Copyright: kzenon / 123RF Stock Photo

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
Copyright: mesutdogan / 123RF Stock Photo

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
Copyright: farakos / 123RF Stock Photo

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
Copyright: alzam / 123RF Stock Photo

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.