CO. SETTLES WITH FTC REGARDING ALLEGED DECEPTIVE CLAIMS ABOUT CHILDREN'S DIETARY SUPPLEMENTS

FROM:  U.S. FEDERAL TRADE COMMISSION 
Company That Touted Products’ Ability to Treat Children’s Speech Disorders Settles FTC Charges It Deceived Consumers

An Illinois company and its owner will stop making allegedly deceptive claims that their dietary supplements are proven effective at treating childhood speech disorders, including those associated with autism, in order to settle Federal Trade Commission charges. Under the FTC settlement, the defendants also will pay $200,000 and are required to disclose any material connections with their endorsers.

“Parents of children with speech disorders need accurate information about products that may be able to help,” said Jessica Rich, Director of the Bureau of Consumer Protection. “This company took advantage of parents’ trust.”

Since at least 2008, NourishLife, LLC and its owner, Mark Nottoli, have sold Speak softgels and capsules and Speak Smooth liquid children’s supplements online and through a network of distributors for more than $70 per bottle. The supplements -- which contain Omega-3 and Omega-6 fatty acids and Vitamins E and K -- were advertised via the Internet, including search engine ads such as Google sponsored links and on websites, and at conferences on autism spectrum disorders.

For example, a Google sponsored link for Speak products, which could display if consumers searched on the term “toddler speech problems,” contained the statement, “Healthy Speech for Child – SpeechNutrients speak Supplement” and linked to a web page claiming the supplements were developed by a pediatrician to support “normal and healthy speech development and maintenance.”  That web page also included a statement from a parent endorsing the product, who said “[my daughter] is speaking in more complex sentences and she is less gittery [sic], more focused.”  Other statements from parent endorsers appeared in product brochures and on speechnutrients.com, such as:

“Speak vitamins have made my little boy talk. He is five years old and has not spoken until I began giving him the vitamins.”

“We were really amazed when Ben started singing along with a song on the radio . . . . and he was singing 3+ word phrases, not just one word here & there.”

According to the FTC’s complaint,between 2008 and late 2013, ads for Speak products made unsupported claims that the supplements develop and maintain normal, healthy speech and language capabilities in children, including those with verbal apraxia -- a motor speech disorder affecting the ability to utter sounds, syllables, and words.

These ads, the complaint asserts, also falsely claimed that Speak products are scientifically proven to improve children’s speech. In addition, the complaint charges that ads for Speak products deceptively claimed that the supplements are effective in treating or mitigating verbal apraxia and communication and behavioral difficulties in children with an autism spectrum disorder.

The FTC’s complaint also charges that the defendants provided promotional materials making these false and deceptive claims for Speak products to third-party distributors that sold the supplements.

In addition, the FTC’s complaint charges that the defendants misrepresented a website called apraxiaresearch.com, which they owned and operated, to be an independent resource for research and other information relating to the treatment of apraxia. In fact, according to the FTC’s complaint, that website advertised the health benefits of defendants’ Speak products. The complaint also asserts that the defendants failed to disclose their affiliation with the Apraxia Research website and with parent endorsers of Speak products who received free supplements.

The proposed order settling the FTC’s charges would prohibit NourishLife and Nottoli from making false or unsubstantiated claims about the effectiveness of any dietary supplement, food, or drug, including but not limited to their Speak products. The proposed order also would bar the defendants from providing third-party distributors with deceptive marketing materials or otherwise providing others with the means to make these prohibited claims.

In addition, it would prohibit the defendants from misrepresenting the independence of any website or other publication that advertises their products, and would require them to clearly and prominently disclose any material connections to any such website or publication, or to any person endorsing their products.

The proposed order imposes a judgment of $3.68 million, which will be partially suspended – based on the defendants’ inability to pay -- after they pay $200,000.

The Commission vote approving the complaint and proposed final order was 5-0. The complaint was filed in the U.S. District Court for the Northern District of Illinois, Eastern Division, on January 7, 2015. A motion for the court to enter the proposed final order was filed on January 9, 2015. The case is part of the FTC’s work to challenge false and deceptive claims about cognitive products for adults and children.

Information for Consumers

When it comes to treatments for health and fitness, it can be tough to tell useful products and services from those that don’t work or aren’t safe. For more information, see the FTC’s guidance on Treatments & Cures.

The FTC is a member of the National Prevention Council, which provides coordination and leadership at the federal level regarding prevention, wellness, and health promotion practices. This case advances the National Prevention Strategy’s goal of increasing the number of Americans who are healthy at every stage of life.

NOTE: The Commission files a complaint when it has “reason to believe” that the law has been or is being violated and it appears to the Commission that a proceeding is in the public interest. Stipulated orders have the force of law when approved and signed by the District Court judge.

FDA SAYS DIETARY SUPPLEMENTS WON'T TREAT CONCUSSIONS

FROM:  FOOD AND DRUG ADMINISTRATION 

Can a Dietary Supplement Treat a Concussion? No.

Exploiting the public's rising concern about concussions, some companies are offering untested, unproven and possibly dangerous products that claim to prevent, treat or cure concussions and other traumatic brain injuries (TBIs).
The Food and Drug Administration (FDA) is monitoring the marketplace and taking enforcement actions where appropriate, issuing warning letters to firms—the usual first step for dealing with claims that products labeled as dietary supplements are intended for use in the cure, mitigation, treatment, or prevention of disease. The agency is also warning consumers to avoid purported dietary supplements marketed with claims to prevent, treat, or cure concussions and other TBIs because the claims are not backed with scientific evidence that the products are safe or effective for such purposes. These products are sold on the Internet and at various retail outlets, and marketed to consumers using social media, including Facebook and Twitter.

One common claim: Using a particular dietary supplement promotes faster healing times after a concussion or other TBI.

Even if a particular supplement contains no harmful ingredients, that claim alone can be dangerous, says Gary Coody, FDA's National Health Fraud Coordinator.

"We're very concerned that false assurances of faster recovery will convince athletes of all ages, coaches and even parents that someone suffering from a concussion is ready to resume activities before they are really ready," says Coody. "Also, watch for claims that these products can prevent or lessen the severity of concussions or TBIs."

A concussion is a brain injury caused by a blow to the head, or by a violent shaking of the head and upper body. Concussions and other TBIs are serious medical conditions that require proper diagnosis, treatment, and monitoring by a health care professional. The long-term impact of concussions on professional athletes and children who play contact sports has recently been the subject of highly publicized discussions.

A growing body of scientific evidence indicates that if concussion victims resume strenuous activities—such as football, soccer or hockey—too soon, they risk a greater chance of having a subsequent concussion. Moreover, repeat concussions can have a cumulative effect on the brain, with devastating consequences that can include brain swelling, permanent brain damage, long-term disability and death.

"As amazing as the marketing claims here are, the science doesn't support the use of any dietary supplements for the prevention of concussions or the reduction of post-concussion symptoms that would enable one to return to playing a sport faster," says Daniel Fabricant, Ph.D., director of FDA's Division of Dietary Supplement Programs.

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The Claims
One of the first alarms raised about dietary supplements being promoted to treat TBI came from the U.S. Department of Defense.
"We first learned from the military about a product being marketed to treat TBI, obviously a concern with wounded veterans. We were taken aback that anyone would make a claim that a supplement could treat TBI, a hot-button issue," says Jason Humbert, a senior regulatory manager with FDA's Office of Regulatory Affairs. "That sparked our surveillance."

FDA routinely monitors the marketplace. However, with more than 85,000 dietary supplements on the market and no product registration, products making false claims can slip through, at least for a time.

Typically, products promising relief from TBIs tout the benefits of ingredients such as turmeric and high levels of omega-3 fatty acids derived from fish oil. Turmeric is an Indian spice in the ginger family. For Omega-3, FDA has recommended a maximum daily level of 3 grams per day from all sources due to possible problems with increased risk of bleeding, increases in cholesterol and problems with controlling blood sugar levels.

In its initial surveillance, FDA identified two companies selling multiple products claiming to prevent and treat concussions and other TBIs. One company claimed to have "the world's first supplement formulated specifically to assist concussion recovery," saying "it has the dynamic ability to minimize long-term effects and decrease recovery time." A National Football League player testified to its "proven results in my own recovery" from a concussion, and an unnamed "licensed trainer" said he had incorporated it into his "concussion management protocol."

Similar claims were made by the other company, which was selling four products claiming to protect against and help heal TBIs. FDA sent letters in 2012 warning both companies that their products were not generally recognized as safe and effective for treating TBIs, that the products were misbranded (a legal term meaning, in this case, that the labeling of the products did not have adequate directions for use), and that unless various violations cited in the letters were promptly corrected, the violations could result in legal action taken without further notice, such as seizure or injunction.

Both companies changed their websites and labeling.

In December 2013, FDA issued a warning letter to Star Scientific, Inc., for marketing its product Anatabloc with claims to treat TBIs. FDA continues to monitor the marketplace for products with similar fraudulent claims, and will take appropriate regulatory action to protect the public health.

"As we continue to work on this problem, we can't guarantee you won't see a claim about TBIs. But we can promise you this: There is no dietary supplement that has been shown to prevent or treat them," says Coody. "If someone tells you otherwise, walk away."

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

Dec. 31, 2013

CONSUMERS TO RECEIVE REFUND CHECKS FOR CERTAIN "COLON CLEANSER" PURCHASES

FROM:  U.S. FEDERAL TRADE COMMISSION 
FTC Sends Refund Checks Totaling nearly $6 Million to Consumers Who Bought Dietary Supplements

An administrator working for the Federal Trade Commission is mailing 316,716 checks averaging $18.74 each to consumers who purchased acai berry supplements, “colon cleansers,” and other products from Phoenix-based Central Coast Nutraceuticals, Inc.

In August 2010, the FTC charged Central Coast Nutraceuticals, two individuals, and four related companies with multiple violations, including unfair billing practices, and deceptively advertising Acai Pure, an acai berry supplement, as a weight-loss product, and Colotox, a colon cleansing supplement, as an aid for preventing cancer.

The checks, which total $5,936,243.63, must be cashed within 60 days after they are issued.  The deadline for filing a refund request has expired.  Consumers who have questions should call (877) 283-6531.  For more general information, see www.FTC.gov/refunds.  The FTC never requires consumers to pay money or provide information before redress checks can be cashed.

Consumers should carefully evaluate advertising claims for dietary supplements.  For more information see:  Dietary Supplements.

The Federal Trade Commission works for consumers to prevent fraudulent, deceptive, and unfair business practices and to provide information to help spot, stop, and avoid them. To file a complaint in English or Spanish, visit the FTC’s online Complaint Assistant or call 1-877-FTC-HELP (1-877-382-4357). The FTC enters complaints into Consumer Sentinel, a secure, online database available to more than 2,000 civil and criminal law enforcement agencies in the U.S. and abroad. The FTC’s website provides free information on a variety of consumer topics. Like the FTC on Facebook, follow us on Twitter, and subscribe to press releases for the latest FTC news and resources.

FTC FORWARDS REFUNDS TO DIETARY SUPPLEMENTS CUSTOMERS

FROM:  FEDERAL TRADE COMMISSION 
FTC Sends Refund Checks to Consumers Who Bought Dietary Supplements

Agency Challenged Marketers’ Claims that Products could Cause Weight Loss; Treat and Prevent Colds, Flu, and Allergies

An administrator working for the Federal Trade Commission is mailing 2,546 checks averaging $71.71 each to consumers who bought Accelis, nanoSLIM, and any Cold MD, Germ MD, or Allergy MD dietary supplements between January 2006 and July 2010.
The FTC charged Iovate Health Sciences U.S.A. and two affiliated Canadian
companies with deceptively advertising that their supplements could help consumers lose weight and treat or prevent colds, flu, and allergies.

The checks, which total $182,573.43, must be cashed within 60 days after they are issued. The amount consumers receive depends upon the amount of claims they submitted that were approved. Consumers were eligible to claim up to five of a single product and up to 10 purchases total.

The deadline for filing a refund request has expired. Consumers who have questions should call 1-877-576-9978 or visit the Iovate Refunds page. For more general information, see www.FTC.gov/refunds. The FTC never requires consumers to pay money or provide information before redress checks can be cashed.

Consumers should carefully evaluate advertising claims for dietary supplements. For more information see: Dietary Supplements.

The Federal Trade Commission works for consumers to prevent fraudulent, deceptive, and unfair business practices and to provide information to help spot, stop, and avoid them.

DIETARY SUPPLEMENTS AND CLAIMS MADE THAT MAY NOT BE TRUE

FROM:  U.S. DEPARTMENT OF JUSTICE
Keeping Tabs On Supplements
June 20th, 2012 Posted by Tracy Russo
The following post appears courtesy of the Consumer Protection Branch of the Civil Division
The dietary supplement industry has grown exponentially in recent decades, expanding from a niche health market into a major industry offering purported solutions for all types of ailments.

In 1994, Congress struck a balance between the dietary supplement industry and the public interest by enacting a law that generally treated dietary supplements as food rather than medicine. That means, for example, dietary supplements are generally not required to go through pre-market approval like pharmaceuticals.  

In 2007, the Food and Drug Administration (FDA) recognized that stronger regulations for the manufacturing of dietary supplements were needed.  Important new requirements have been introduced, in an effort to ensure that dietary supplements contain what they claim to contain.

In the last few years, the Consumer Protection Branch of the Civil Division, the FDA, and the Federal Trade Commission have collaborated in a number of actions designed to protect consumers.   When its inspections reveal serious deficiencies in a dietary supplement firm’s labeling, manufacturing, or advertising, the FDA typically sends the firm a warning letter giving the firm a certain amount of time to rectify the violations, and may work with the firm to recall products with potential risks.  You can find out about these actions and protect yourself by signing up for FDA recall alerts and by checking the FDA and FTC websites for warning letters issued to firms whose dietary supplements you may have purchased.

If the firm does not remedy the violations, the matter may be referred to the Justice Department for civil or criminal prosecution.  In one recent case, the Consumer Protection Branch filed a civil suit against a Paterson, NJ-based supplement maker that had a serious rodent infestation, manufacturing problems that resulted in allergen cross-contamination, and various labeling errors.  One of the firm’s products—which had been labeled to be dairy-free but in fact contained milk—even caused a life-threatening anaphylactic reaction in a consumer with a severe milk allergy.

Flouting a court-ordered shut down, the manufacturers simply opened up shop in a new location.  Ultimately, the Justice Department secured a criminal conviction and the firm was ordered to pay $1 million in fines.  Perhaps more significantly, the three principals of the firm were given lengthy prison terms: 40 months for the president and 34 months for the production and quality assurance managers.

Violations in the dietary supplement industry will not be tolerated.  Consumers turn to these products for their health and sense of well-being.  Consumers rely on the labels of dietary supplements to tell them about the effectiveness of the supplements and the allergens in the product.  Consumers should be able to trust that the companies that produce dietary supplements make sure their products are free from harmful impurities and manufactured under sanitary conditions.