© Getty Images

The National Advertising Division, referred Pharmavite, LLC to the Federal Trade Commission after the company refused to comply with NAD’s recommendations that it discontinue its claim that its NatureMade Omega 3 Xtra Blend dietary supplement has “Nearly 4X Better Absorption* *than standard fish oil concentrate.”

To substantiate its “Nearly 4X Better Absorption” claim, Pharmavite relied on a study that compared the absorption of 630 mg and 1680 mg doses of EPA/DHA omega 3 fatty acids manufactured with and without a self-microemulsifying drug delivery system (SMEDS). The study determined that the absorption of EPA/DHA manufactured with SMEDS was better than the absorption rate of standard fish oil (manufactured without SMEDS) for the two doses of EPA/DHA. The study concluded that there was a 6.2 differential for a 630 mg dose and a 9.6 differential for a 1680 mg dose.

Continue Reading Pharmavite, Maker of NatureMade Omega-3 Xtra Blend Dietary Supplement, Referred to FTC After Declining to Comply with NAD Recommendation to Discontinue Absorption Claim

Smartphone app image
Photo courtesy of Flickr by highwaysengland

 

The FTC continued its campaign against deceptive health and disease claims with enforcement actions against the marketers of “MelApp” and “Mole Detective,” smartphone apps that claimed to detect melanoma. These enforcement actions follow earlier FTC actions against smartphone apps that claimed to cure acne.

The Commission voted 4-1 to settle deceptive advertising claims against the Mel App defendant and two of the Mole Detective defendants and to litigate against the remaining two Mole Detective defendants.  Commissioner Ohlhausen disagreed with the majority’s interpretation of the melanoma detection claims and thus with the amount of substantiation required.  The settlement agreements require defendants to substantiate future melanoma-related claims with “competent and reliable scientific evidence [that] shall consist of human clinical testing” that meets rigorous scientific standards.  Consistent with her analysis in POM Wonderful, Commissioner Ohlhausen’s dissent made clear that she  would not require such “onerous” substantiation because “substantiation requirements must flow from the claims made by the advertiser” and “[w]ithout extrinsic evidence, I do not have reason to believe that a reasonable consumer would take away the implied claim that using these apps would increase their chances of detecting skin cancer in the early stages as compared to an examination by a dermatologist.”

Continue Reading Holy Moly! FTC Says Smartphone Apps Don’t Detect Skin Cancer

128021458Perusing the labels at your typical cosmetics counter or pharmacy aisle can feel akin to reading the menu of options for a smoothie bar.  “Antioxidants,” “Aloe,” “Vitamin C,” “Almond extract,” “natural fruit,” and “protein” all appear to be popular options.  When it comes to specifics, labels often vary from saying that an ingredient is contained in the product to simply splashing the ingredient name in bold font, unmodified.

Why does this matter from a legal stand point?  Just like any other advertising claim, claims about product content require reasonable substantiation, and must not be misleading.  The risk in touting a particular product ingredient is often less about whether the claim is literally true, and more about whether it implies a greater amount or performance impact than actually provided.

The highly publicized POM Wonderful LLC v. Coca-Cola Co. case put ingredient claims in the spotlight when POM Wonderful challenged Coca-Cola’s use of the use of the words “Pomegranate Blueberry” on its juice label when the product contained only 0.3 percent pomegranate juice and 0.2 percent blueberry juice.  The United State Supreme Court overturned a lower court ruling, and found that POM Wonderful could proceed with its Lanham Act claims. The case was remanded back to the Ninth Circuit where it remains pending – meaning a little ingredient claim may give rise to big money litigation. (For more background on the POM Wonderful caseclick here.)

So far, like in POM Wonderful, food products have been the primary target of legal challenges, but nail care products and tanning cream have been the subject of competitor challenges based on the effectiveness of the publicized ingredients, and shampoo and sunscreen have been the target of “natural” claims litigation based on their contents.  In-house counsel for cosmetics and personal care companies should take note.  If your company’s called-out ingredients are called out, can you stand behind how much cucumber is in your eye cream?

As the storm of concussion-related litigation continues to churn, the Federal Trade Commission is once again wading into its turbulent waters. In August, the FTC sent warning letters to five undisclosed “major” retailers, expressing concerns that athletic mouthguards are being advertised deceptively on the retailers’ web sites as helping to prevent concussions. These FTC letters represent the convergence of two trends at the Commission: (1) a recent focus on advertising claims of concussion prevention/protection; and (2) sustained efforts to hold retailers accountable for advertising claims concerning the products on their shelves.

Retailers in the Crosshairs

The FTC’s letters mark the first time that the Commission has called retailers to account for allegedly deceptive concussion claims. They cite a 1977 FTC decision, Porter & Dietsch, Inc., for the proposition that retailers “can be liable for violating the FTC Act by disseminating false or unsubstantiated claims.” The FTC cited an example of a specific (and redacted) product, and recommended that the retailers review their web sites to ensure that they do not contain “concussion protection claims for which competent and reliable scientific evidence does not exist.” The FTC stated its intent to revisit the retailers’ web sites within 90 days, and implied that enforcement actions would be forthcoming if unsubstantiated claims were not removed.

FTC’s concussion warning letters continue a trend of the Commission using the threat of enforcement against retailers essentially to turn them into deputized enforcers of false advertising rules. This practice places a substantial burden on retailers to demand substantiation of potentially questionable claims from product manufacturers.

Continue Reading FTC Warns Retailers to Police Their Products’ Deceptive Concussion Prevention Claims