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 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 Warns Cosmetic Companies to Tone Down Anti-Aging Claims

After years of looking the other way, the FDA is going after cosmetic companies for how they market their products.  In the past two months, the agency sent warning letters to at least six companies, including Avon and Lancôme, for making drug-like anti-aging claims about their products.  As a comparison, according to the FDA's public database, the agency only issued between one to three warning letters per year between 2004 and 2011 (none between 2006 and 2010) regarding similar claims.

Claims made for these products to which the FDA objected include:

• The at-home answer to wrinkle-filling injections. Start rebuilding collagen in just 48 hours.
• Rebuild collagen to help plump out lines and wrinkles.
• Stimulate elastin to help improve elasticity and resilience.
• Regenerate hydroproteins to help visibly minimize creasing.
• helps reactivate skin’s repair process to recreate fresh skin & help dramatically reverse visible wrinkles.
• help boost production of collagen and elastin.
• See significant deep wrinkle reduction in UV damaged skin, clinically proven.
• Immediate lifting, lasting repositioning. Inspired by eye-lifting surgical techniques . . . helps recreate a younger, lifted look in the delicate eye area.

Under the federal Food Drug & Cosmetic Act, a product intended to diagnose, mitigate, treat, or prevent disease, or to affect the structure or function of the body is classified as a drug.  If such a product is not generally recognized by qualified experts as safe and effective when used as labeled, it is a “new drug” and requires an approved New Drug Application to be marketed legally in the U.S.

The FDA gave these companies 15 days to respond to the warning letters.  If you have any questions about the warning letters or any claims about your cosmetic products, please contact the firm.

Avon Warning Letter: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm323738.htm

Lancôme Warning Letter: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm318809.htm

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.

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.

Latest regulatory trends from RAPS conference

There were several excellent speakers at the RPAS (Regulatory Affairs Professionals Society) annual conference in San Jose last week.  They represented regulatory professionals in the private and public sectors, both domestically and abroad.  Here are some of the take-away messages from the speakers:

• FDA is stepping up enforcement.  This shouldn't come as a surprise if you've been following the agency's enforcement actions lately.  In his speech to the food and dietary supplement industry, FDA's Chief Counsel Ralph S. Tyler stated that the agency has just began its enforcement efforts and that more are yet to come.  Among the areas of concern are the good manufacturing practices (GMP) regulations for dietary supplement products, as well as the notification requirements for new dietary ingredients.  The agency also intends to hold individual more accountable for violations, which would result in more criminal prosecutions of company executives and even employees.
• FTC is stepping up enforcement.  Similarly, the FTC is stepping up enforcement in the area of claim substantiation.  The FTC will be looking at scientific data more closely to determine whether they support claims made about a product.   Companies should pay more attention to testimonials, because according to the government, they are never substantiated. 
• Companies are very interested in the Chinese market, but are frustrated by the regulatory framework there.  Among the conference speakers were five officials from the Chinese State FDA (SFDA), who provided an overview of the medical device approval process in China.  This presentation was one of the popular ones at the conference, and the numbers and types of the questions asked at the end of the presentation showed many companies (large and small) are very interested in the Chinese market, and yet are frustrated with the lack of transparency in the approval process.  Here are some of the policies that can cause frustration:
• According to a SFDA official, if a foreign company manufactures a medical device in China, the company will have to export the finished product out of China.  However, if a Chinese company puts its own label on the same product, it will be able to sell the device in China.  This policy seems to have little to do with safety and efficacy.  
• Also according to the same official, a medical device imported into China will not receive SFDA approval if the device has not received market approval in the country of origin.  The message seemed to be: if this device is not good for your country, it's not good enough for China.
• Questions were asked about whether the SFDA would accept data from clinical trials done outside of the China.  The answer was as clear as water - generally no, but we will decide on a case by case basis, but if we decided you need to do more clinical trials, you need to conduct them in China.  
• Questions were asked about whether the SFDA would meet with companies to discuss their products before the companies submit their applications for approval of their products.  The answer was that the SFDA holds a "open forum" every Thursday during which anyone can participate in a Q&A session with the agency to discuss any regulatory issues.  According to the SFDA official, no appointment is required and people can participate by phone.  So much for confidentiality. 

I am still reviewing my notes and materials from the conference, and plan to blog about other interesting topics I ran across there.

The Fed took action against unapproved "drug" manufacturer

The federal government has barred a Montana company from the manufacture and sale of unapproved new drugs and dietary supplements, the FDA announced this week.  The order came in the form of a consent decree, filed in U.S. District Court for the District of Montana Wednesday and subject to court approval.

According to the FDA, the company manufactured and distributed a variety of unapproved new drugs that "were ineffective in treating the diseases they claim to treat."

The products - sold under such names as Black Salve, Cancema and Can-Support -- included topical salves purported to treat skin cancer, and oils and capsules to combat "serious diseases such as breast cancer, asthma, anemia and epilepsy," according to the FDA.

The FDA characterized many of these products as dietary supplements.
"The FDA will not tolerate unsubstantiated health or disease claims that may mislead customers," Autor said. "The FDA is committed to ensuring that consumers do not become victims of false cures."

In signing the consent decree, the company agreed to stop making and selling unapproved new drugs and products with unauthorized health claims and to hire an independent expert to review claims made for any future products, according to the statement.

Had the company hired an independent expert to review claims made for their products before they put them on the market, I suspect they would not have ended up in such deep trouble.

FTC has no business regulating speech from the heart, says POM Wonderful

Last week, the Federal Trade Commission (FTC) charged POM Wonderful, the maker of a brand of pomegranate juice, with making unsubstantiated health claims about its products.

The federal agency said the juice and supplements firm made "false and unsubstantiated claims that their products will prevent or treat heart disease, prostate cancer, and erectile dysfunction."  The complaint says the company "violated federal law by making deceptive disease prevention and treatment claims" with ads in the New York Times and other publications and on the Internet.

In an editorial published by the LA Times, Michael Hiltzik takes a closer look at POM's reactions to the charge, as well as the scientific research, which was funded by the company, behind the health claims.

It is not surprising that the people at POM are outraged by the charge and content that the federal government is infringing on their right of free speech.

The most interesting part of the editorial is perhaps POM's assertion that the company owner's (Lynda Resnick) statements about the product should not be taken as an "advertisement" and that since they were made in an interview, they are none of the FTC's business.

According to POM, Resnick is "talking about what she personally believes with respect to the science that she's seen. ... Lynda's not a doctor, she's not offering scientific opinion; she's speaking ... as an individual from the heart about what she believes."

A company generally cannot have someone say something for the company that it cannot say under FTC or FDA regulations.   Like Mr. Hiltzik, I am interested in seeing whether POM Wonderful can make that argument stick with the FTC.