FTC takes actions against makers of weight-loss products

The Federal Trade Commission (FTC) announced enforcement actions against four companies the agency said used deceptive advertising claims to sell weight-loss products.   In total, the four companies - Sensa, L'Occitane, HCG Diet Direct and LeanSpa - have agreed to pay about $34 million for consumer redress. 

The FTC has also updated guidance for publisher and broadcasters on how to spot phony weight-loss claims when screening ads for publication.  “Gut Check: A Reference Guide for Media on Spotting False Weight-Loss Claims” describes seven weight loss claims that can’t be true and should prompt a “gut check” – a second look to make sure publishers are not running advertisements with claims known to be false.  The guide also contains advice on dealing with problematic areas like consumer testimonials and fine print disclosures.  The Gut Check guidance updates the Red Flag Bogus Weight-Loss Claims reference guide for media that the FTC first published in 2003.

Sensa sold a sprinkle-on food additive that promised users would lose weight without exercising.  Users paid about $60 for one-month supply of Sensa products, which were sold online and at retail chains that included Costco and GNC.  U.S. retail sales between 2008 and 2012 totaled more than $364 million, according to the FTC.  The FTC said Sensa used faulty science in its marketing to mislead consumers and ordered the company to return $26.6 million to consumers.  The case was filed against Sensa, its parent firm, and two individuals who was chief executive and co-owner of the company.

L'Occitane, which the FTC said had no evidence to back up the claim that its skin cream would slim down a person's body, will pay $450,000.  HCG Diet Direct, which marketed a human hormone for weight-loss treatments, will surrender about $7.3 million in assets.

The fourth company, LeanSpa, which marketed acai berry and colon cleanse supplements, was granted a suspended settlement from the FTC because the company's inability to pay.

Weight-loss products remain one of the FTC's top enforcement priorities.   Makers of weight-loss products should ensure that their product claims (including testimonials used) are truthful, not misleading and supported by scientific evidence.

FDA Issues Proposed Rules for Antiseptic Drug Products

The U.S. Food and Drug Administration (FDA) issued a new proposed rule to amend its 1994 tentative monograph for OTC antiseptic drug products.  The FDA is proposing to establish new conditions under which OTC consumer antiseptic products are generally recognized as safe and effective ("GRASE").  The FDA states that additional safety and effectiveness data are necessary to support a GRASE ruling for OTC antiseptic active ingredients intended for repeated daily use by consumers.  The Proposed Rule does not affect hand sanitizers, wipes or antibacterial products used in hospitals and other healthcare settings.

According to the FDA, no evidence exists that these products are more effective in preventing illness than washing with regular soap and water.  Further, some antibacterial chemicals used in OTC consumer antiseptic soap products (such as triclosan) may affect certain hormones in the body and contribute to the growing problem of antibiotic resistance.

Based on the data currently available, the FDA finds with this new Proposed Rule that consumer antiseptic wash active ingredients can be considered neither safe nor effective for use in OTC consumer antiseptic wash drug products.  The new rule will be effective one year after it is finalized.  After the effective date, all OTC consumer antiseptic products that do not comply with all requirements in the monograph will be deemed misbranded if they are not subjects of approved New Drug Applications ("NDA").

The FDA is accepting public comment on the Proposed Rule, as well as new data or information, for 180 days.  After the comment period, the FDA will review all available data as well as newly submitted data to determine if the information is adequate in determining the safety and effectiveness of OTC consumer antiseptic active ingredients intended for repeated daily use.

FDA Regulates Keyword Searches on the Internet

The U.S. Food and Drug Administration recently sent a Warning Letter to M.D.R. Fitness Corp., a Florida-based researcher and manufacturer of nutritional supplements.  In the letter, the FDA alleges a number of problems, but the one that's catching attention concerns the company's website search engine.

According to the FDA, typing the keyword "cancer" or "diabetes" into the product search field located on the company's website brings up several products.  Because those products are associated with disease terms, the FDA said, the company is thus “implying that its products are intended for use in the diagnosis, cure, mitigation, treatment or prevention of such diseases,” which make them unapproved new drugs.

In a previous case, the FDA used metadata as evidence of intended use involving another company's dietary supplement.  Metadata are similar to keyword association in that both are largely invisible to the public.  These recent cases indicate that the FDA is targeting word associations on product websites. 

FDA issues guidance for off-label communication

The FDA issued draft guidance this week clarifying conditions under which drug and medical device makers may provide information on off-label uses.  The draft guidance covers unsolicited requests for off-label information.  An unsolicited request is one not initiated in any form by the drug or device maker (or its affiliates) itself.

For a company's response to nonpublic (one-on-one communication) unsolicited requests, the agency has made the following 7 recommendations:

• Response information should be limited to the requestor and treated as private, one-on-one communication.
• Information should be limited to the scope of the initial question.
• Information should be "truthful, non-misleading, accurate, and balanced."
• Information should be scientific in nature.
• Information should be generated "by medical or scientific personnel independent from sales or marketing departments."
• Information should be accompanied by several documents, including a statement notifying the recipient that FDA has not approved the product for the specific off-label use.
• The responding firm should maintain required records, including any follow-up questions from the requester.

For a company responding in public to public (Web sites, discussion boards, and chat rooms that are created and maintained by people other than the manufacturer or its affiliates) unsolicited requests, FDA makes the following 4 recommendations:

• A firm should respond only to a request about its own named product and is not solely about a competitor's product.
• The firm's response "should be limited to providing [its] contact information and should not include any off-label information."
• Those responding on behalf of the firm should clearly disclose their specific involvement with that firm.
• Responses "should not be promotional in nature or tone."

Public comments and suggestions regarding the draft guidance should be submitted within 90 days its publication.

FDA Issues New Labeling Rules for Sunscreen

After 33 years of consideration, the FDA today announced new labeling requirements for sunscreen OTC drug products.  The new requirements are effective June 18, 2012.  However, the compliance date for products with annual sales less than $25,000 is June 17, 2013.

Under the new rules, sunscreens must protect equally against UVB and UVA to earn the designation of offering "broad spectrum" protection.   UVB causes burns, and UVA causes wrinkles.  Both forms of radiation can cause skin cancer.

Products that have SPF values between 2 and 14 may be labeled "broad spectrum" if they protect against both UVB and UVA, but only those with a SPF value of 15 or greater may state that they reduce the risk of skin cancer and early skin aging.  Products that are not broad spectrum, or that are broad spectrum but which don't have an SFP of at least 15, will have to carry a warning stating that they have not been shown to help prevent skin cancer or early skin aging.

The new rules will also bar the use of the terms “sun block,” “waterproof” and “sweatproof."  Instead, sunscreens can be labeled as “water resistant” and must specify if they work for 40 or 80 minutes. Those that are not water resistant must carry a warning label advising people to use a water resistant product if they are going to be exposed to water or sweat.

The agency also proposed a new regulation that would limit the maximum SPF value on sunscreen labels to “50 +.”  The agency said there is insufficient evidence to show that products with SPF values higher than 50 provide greater protection than those with SPF values of 50.

Sunscreen makers could, however, submit data to support including higher SPF values.

In addition, the agency will begin accepting data about the safety and effectiveness of sunscreen sprays and comments on possible warnings for sprays.

Design-defect Claims Against Vaccine Makers Preempted, Supreme Court Rules

The Supreme Court on Tuesday shielded the nation's vaccine makers from being sued by parents who say their children suffered severe side effects from the drugs.

By a 6-2 vote, the court upheld a federal law that offers compensation to these victims through a special tribunal but closes the courthouse door to lawsuits.

The majority said that Congress found such a system necessary to ensure that vaccines remain readily available, and that federal regulators are in the best position to decide whether vaccines are safe and properly designed.

The National Childhood Vaccine Injury Act of 1986 "reflects a sensible choice to leave complex epidemiological judgments about vaccine design to the FDA and the National Vaccine Program rather than juries," Justice Antonin Scalia wrote, referring to the Food and Drug Administration.

Justices Sonia Sotomayor and Ruth Bader Ginsburg dissented, saying the threat of lawsuits provides an incentive for vaccine manufacturers to constantly monitor and improve their products.

The decision "leaves a regulatory vacuum in which no one - neither the FDA nor any other federal agency, nor state and federal juries - ensures that vaccine manufacturers adequately take account of scientific and technological advancements," Sotomayor wrote.

The case was brought by Russell and Robalee Bruesewitz on behalf of their daughter Hannah, 18. Hannah began to have seizures as an infant after receiving the third of five scheduled doses of Wyeth's Tri-Immunol diphtheria-pertussis-tetanus vaccine. The company, now owned by Pfizer, has taken the drug off the market.

The 1986 federal law said that all such claims must first go to a special tribunal commonly called the "Vaccine Court." The program has awarded nearly $2 billion for vaccine-injury claims in nearly 2,500 cases since 1989. It is funded by a tax on immunizations.

But the tribunal ruled against the Bruesewitzes, saying they had not proved that the vaccine harmed Hannah, who will need life-long care.

The couple then sued under Pennsylvania tort law. The company had the case moved to federal court, and judges have consistently ruled that the suit cannot proceed, because federal law prohibits claims against "design defects" in vaccines.

The justices at oral argument debated ambiguous wording in the federal law. It says that no vaccine maker can be held liable for death or injuries arising from "side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings."

Scalia said the word "unavoidable" would be meaningless "if a manufacturer could be held liable for failure to use a different design."

Sotomayor read the language to mean the opposite, and said "text, structure and legislative history compel the conclusion that Congress intended to leave the courthouse doors open for children who have suffered severe injuries from defectively designed vaccines."

The case is Bruesewitz v. Wyeth.

Dannon fined for making health claims for its yogurt product

The Dannon Company will pay a $21 million fine and stop making exaggerated health claims for two very popular Dannon products under an agreement with the federal government and attorneys general from 39 states.

Dannon will stop claiming that one daily serving of Activia yogurt relieves irregularity and that its DanActive dairy drink helps people avoid catching colds or flu, the Federal Trade Commission announced on Wednesday.

"These types of misleading claims are enough to give consumers indigestion," says FTC Chairman Jon Leibowitz. "Companies like Dannon shouldn't exaggerate the strength of scientific support for their products."

The move signals a more aggressive federal watchdog roll over deceptive advertising practices by major marketers under the Obama administration

The FTC charged that Dannon's ads were deceptive because it did not have substantiation for its claims. The commission also charged that Dannon's claims that Activia and DanActive were clinically proven were false.

The FTC complaint and settlement can be downloaded from the FTC website at: http://www.ftc.gov/opa/2010/12/dannon.shtm. 

Here are some tips on substantiation of product claims: http://business.ftc.gov/documents/substantiation-science-compliance.

Court held that FDA can only regulate e-cigarettes as tobacco products

A federal appeals court ruled yesterday that the FDA can only regulate electronic cigarettes (e-cigarettes) as tobacco products and not as drug-delivery products, and therefore cannot block their import.  The ruling will allow e-cigarette maker Sottera Inc. to resume importing its NJOY products.

The FDA and other public health organizations had argued e-cigarettes should be regulated as drug-delivery devices. That would require proving that they are safe and effective as a stop-smoking aid using expensive clinical trials.

A three-judge panel of the U.S. Court of Appeals in Washington backed a lower court ruling that the devices should be considered under the agency's authority over tobacco.  Congress passed the Tobacco Act in 2009 to give the FDA authority to regulate tobacco products -- but not to ban them.

"The liquid nicotine in each e-cigarette is derived from natural tobacco plants."  Therefore the products are a "tobacco product" as defined by the Tobacco Act. 

However, one of the three judges on the panel appeared to be willing to reconsider this issue again if the FDA were to issue its own interpretation of "tobacco product" through the rule making process.   Also, the FDA may appeal this ruling in the Supreme Court.  In the mean time, the ruling says that the FDA can only regulate e-cigarettes as tobacco products, provided that they do not make any drug or therapeutic claims. 

The case is Sotera, Inc. v. FDA, case  no. 10-5032.  A copy of the opinion can be downloaded here.