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by BakerHostetler
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In This Issue:

  • Abbott’s Baby Formula Advertising Challenged by Mead Johnson
  • Natural Supplement Maker Sues Rival Under Lanham Act
  • Decades-long Milk War Froths On
  • Court Continues Hold on Patent Service’s Activities, Assets
  • Blog of Note: UGC Uncertainty Consternation Continues
Abbott’s Baby Formula Advertising Challenged by Mead Johnson

Advanced ingredient requires specific “not from mom” label

Formula Forward

Abbott Nutrition did something unique.

It added a new ingredient to its Similac Pro-Advance and Pro-Sensitive infant formulas that, until now, had only been available in human breast milk: 2’-fucosyllactose human milk oligosaccharide, or 2’-FL HMO. This particular carbohydrate, the most abundant chemical of its kind in the milk of most American mothers, has been linked to demonstrated benefits for babies, including boosts to their immune system.

It’s the Source

When Mead Johnson Nutrition challenged Abbott’s advertising before the National Advertising Division (NAD), it didn’t dispute the nature of the new ingredient, or the claims that have been made about its benefits. Instead, it challenged the use of the words “human milk” in advertising the product.

Abbott had used several tag lines with the phrase, including “COMING SOON SIMILAC WITH HUMAN MILK OLIGOSACCHARIDE” and “Closest to breast milk . . . Unlike other formulas, we have 2’-FL HMO, an immune-nourishing prebiotic that circulates throughout the body.” NAD also reviewed whether the ingredient was “derived from human milk or that only Abbott products provide immune nourishing benefits.”

The Decision

In its decision, NAD dispensed of the notion that Abbott was making a boast about Similac’s superiority. The company, NAD maintained, was merely advertising its exclusive use of the ingredient. The product benefits were also not in dispute.

On the central concern regarding the human milk claims, NAD recommended that Abbott add “not from human milk” in a conspicuous fashion to ensure the advertising did not play on the preference of new parents for products derived from human milk. The division also recommended that existing advertising be adjusted to make the same notice conspicuous.

The Takeaway

Abbott Nutrition agreed with the requested changes, and promised to comply fully with NAD’s decision.

Natural Supplement Maker Sues Rival Under Lanham Act

Alleges advertising pumps up synthetic steroid health claims

Too Good …

SARMs (selective androgen receptor modulators) are synthetic drugs designed to have effects similar to those of illegal anabolic steroids, but with a much more targeted range of effects – making them applicable in a larger range of uses and therapies.

Plaintiff Nutrition Distribution, producer of a SARM-free muscle development supplement, filed a complaint recently against Wicked Nutrition Labs, a maker of a SARMs-based supplement, in the Southern District of California. The suit alleges that Wicked is harming consumers by passing these dangerous drugs off as dietary supplements; Nutrition Distribution claims that SARM-based products pose health risks to consumers, including liver damage and a heightened risk of heart disease – bad news for the weight lifters, bodybuilders and other athletes who are adopting Wicked’s SARMs products to enhance performance and physical appearance.

Alleged Benefits?

Nutrition Distribution, which does business under the “Athletic Xtreme” moniker, accuses rival Wicked of making false and misleading marketing claims regarding its SARMs-based product. In addition to mislabeling its SARM products as “dietary supplements,” the complaint alleges that Wicked falsely advertises its products as providing the benefits of traditional anabolic/androgenic steroids without the harmful side effects.

The Takeaway

The federal Food, Drug and Cosmetics Act precludes companies from suing each other for labeling violations, such as the ones alleged in this case. However, the Lanham Act provides another legal avenue, permitting competitors to sue their rivals for unfair competitive practices. Nutrition Distribution’s suit seeks to enjoin Wicked from producing and marketing its SARM products, as well as seeking compensatory damages and the award of Wicked’s profits under the Lanham Act. Nutrition Distribution recently filed suit against Dynamic Technical Formulations, another rival, on similar grounds.

Decades-long Milk War Froths On

FDA still pouring over terminology decision

Jarndyce v. Jarndyce

We’re all familiar, by this point, with products such as soymilk and almond milk – beverages that are often placed in the grocery store next to conventional dairy products. But consumers might be surprised to learn that the peaceful coexistence of the products is a mere front for an intermittent, seemingly interminable legal battle worthy of a Dickens novel.

The fight over whether plant-based products can be labeled as “milk” has been continuing on and off for 20 years. Two decades ago, the Soyfoods Association petitioned the Food and Drug Administration (FDA) for a common or usual name regulation to recognize the term “soymilk” as the proper terminology for “the liquid food that is obtained as a result of combining aqueous-extracted whole soybean solids and water.”

The National Milk Producers Federation (NMPF) fired back with a letter to the FDA, claiming that the law prohibited the use of the word milk when labeling products that were not derived from cows, and asked the FDA to enforce their interpretation. The Soyfoods Association responded in turn, arguing that the NMPF’s interpretation was correct but narrowly applied: If the term milk was qualified with the source from which the product was derived – soymilk, for example – the law remained unviolated.

The association also noted that their original petition remained unanswered after three years. Little did they know.

20 Years Later …

Today, the battle remains unresolved. In a recent letter issued by the FDA in response to a March 2017 petition by the Good Food Institute, the administration wrote that it was “not able to reach a decision on [the] petition…because of other agency competing priorities.” The letter went on to promise review and consideration of regulatory changes “as warranted and in the context of other program priorities within the Center.”

In the interim between the institute’s petition and the original Soyfoods Association letter from 1997, there had been a number of efforts by participants on either side of the debate to advance their cause, culminating in the “Dairy Pride Act,” legislation introduced by Sen. Tammy Baldwin of Wisconsin in January that would require nondairy products to no longer be labeled with dairy terms such as milk and “cheese.” The bill has been sent to Committee.

The Takeaway

The Good Food Institute’s petition proposes an amendment to the regulatory regime allowing qualifying words to be added to a food name to specify its source, usage the institute argues is widely understood and accepted by consumers.

The institute also provides an in-depth legal argument, holding that its proposed change is consistent with the FDCA’s and the FDA’s policy and practices, and that restrictions on commercial speech would be brought under heightened judicial scrutiny that they would not be likely to withstand.

Court Continues Hold on Patent Service’s Activities, Assets

FTC alleges company offered bogus promotion and protection services to hopeful inventors

Freeze!

In late August, the Southern District of Florida ordered a preliminary injunction against World Patent Marketing (WPM), a patenting and invention-promotion service provider. The injunction, issued with the expectation that the Federal Trade Commission’s (FTC’s) case against WPM would be successful, forbids the company from misrepresenting its products or services and from making threats against people who complain about the company.

The injunction is the most recent development in the FTC’s case against WPM, which it launched in March.

Great Idea

That original complaint accused the company of running a promotion scam targeting inventors that “bilked thousands of consumers out of millions of dollars.” The suit alleges that WPM made promises to aspiring inventors that their service would create a patent for the inventors’ product, and that accompanying agreements for manufacturing and licensing would help the inventors make money off their creations. Specifically, the FTC claimed, WPM devised marketing materials that created a false impression that the company had actually helped other inventors in the past – when the company had no track record of success in doing so.

The FTC alleged that inventors that made it onto WPM’s radar would be contacted by company representatives pushing a patent analysis product for about $1,200. The analysis was invariably positive; later steps in the alleged scam included patent protection and promotional service packages priced at as much as $60,000. The services themselves, the commission alleges, are bogus.

The marketing assault occurred on a wide front, including internet, television, email, telemarketing and standard postal mail advertisements. The website featured profiles of products that the company had supposedly helped develop, and testimonials from the inventors. But the FTC claims that there has been little success with many of these featured products, and the inventor endorsements occurred quite early on in the customers’ relationships with WPM – far too early to justify their claims.

Additionally, when clients would threaten complaints about the company’s performance, WPM would make a variety of legal threats against them, including promises of extortion and defamation lawsuits.

The Takeaway

The preliminary injunction extends a freeze put on WPM’s activities by a temporary restraining order that the FTC obtained shortly after filing the initial complaint.

WPM and its co-defendants argued against the motion, claiming that their business model had changed from analyzing and filing potential patents to developing and marketing the inventors’ ideas. Unfortunately for WPM, the court found that the evidence – including an undercover investigation by the commission – indicated that the company continued to offer the same services as before, as well as the same misrepresentations.

The preliminary injunction prohibits misrepresentations, false marketing of services and the suppression of customer complaints, and freezes WPM’s assets.

 

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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