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FTC comes down hard on claims of some genetic and metabolic nutrition products

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The marketers of a cactus-based fruit drink have agreed to provide $3.5 million for consumer refunds in order to settle FTC charges that they deceived consumers with unsupported claims that their drink, Nopalea, would treat a variety of health problems.The settlement with dietary supplement company TriVita, Inc. is part of the FTC’s ongoing efforts to stop over-hyped health claims, says the July 15, 2014 news release, "FTC: Claims that Drink Relieves Pain, Inflammation, and Respiratory and Skin Problems Are Unfounded."

Cactus juice marketers now are required to Pay $3.5 million in refunds to consumers for deceptive claims that their product treats diseases. But what if the product didn't treat a disease, but actually prevented a disease from happening in the first place based on dense nutrients that the body uses? It looks like now nobody would know, unless scientists show what nutrients were in the juice or what the juice was mixed with to coax people to like the taste, for example sweeteners that get people coming back for more. The question remains in the minds of people looking for dense nutrition.

Perhaps if you want juice from prickly pears, you grow the prickly pears and juice them yourself without any sweeteners added or without any processing at all or you remove the needles from the prickly pear and eat it, if it's safe to eat raw. However you look at the field of metabolic and genetic nutrition, raw foods, or juicing, the result is that TriVita markets 32-ounce bottles of the “prickly pear” fruit drink, derived from the Nopal cactus, for up to $39.99 plus shipping and handling. But, you can grow the cactus yourself. People eating cactus in Central America don't pay nearly $40 dollars to drink or eat Nopal cactus, found raw in many local Sacramento and other Mexican or Hispanic ethnic food stores.

According to the FTC’s complaint, advertisements on the defendants’ websites tout “Inflammation Relief without a Prescription.” The defendants’ infomercials featuring celebrity endorser and former supermodel Cheryl Tiegs, market Nopalea as an “anti-inflammatory wellness drink” that relieves pain, reduces and relieves joint and muscle swelling, improves breathing and alleviates respiratory problems, and relieves skin conditions.

Trivita’s former Chief Science Officer, Brazos Minshew, also appears in the infomercials and links inflammation to allergies, Alzheimer’s disease, heart disease and diabetes. He notes in one of the infomercials that “over 200 articles published and archived at the National Institutes of Health demonstrate one thing: the Nopal cactus will reduce inflammation.” The infomercials also feature testimonials by satisfied consumers who are actually paid employees of defendants, according to the complaint.

“These kinds of unfounded claims are unacceptable, particularly when they impact consumers’ health,” said Jessica Rich, Director of the FTC’s Bureau of Consumer Protection. “Advertisers who cannot back up their claims with competent and reliable scientific evidence are violating the law,” says the FTC's news release.

The defendants are charged with violating Sections 5 and 12 of the FTC Act by:

  • making unsupported claims that Nopalea significantly improves breathing and relieves sinus infections and other respiratory conditions, and provides significant relief from pain, swelling of the joints and muscles, and psoriasis and other skin conditions.
  • making false claims that the health benefits of Nopalea were proven by clinical studies.
  • failing to disclose that supposedly ordinary consumer endorsers were in fact TriVita sales people who received commissions for selling the defendants’ products.

Besides TriVita, Inc., the complaint names as defendants marketing company Ellison Media Company, and Michael R. and Susan R. Ellison, who control both companies.

Under the proposed settlement order, the defendants are barred from making the health claims alleged in the complaint when marketing Nopalea or any food, drug, or dietary supplement without randomized, double-blind, placebo-controlled human clinical tests conducted by qualified researchers; making any health claims without competent and reliable scientific evidence; misrepresenting that health benefits are clinically proven when they are not; and failing to disclose any material connection between endorsers of their products and themselves.

Consumers should carefully evaluate advertising for products that claim to cure diseases. For more information, see: Miracle Health Claims.

The Commission vote authorizing the staff to file the complaint and approving the proposed settlement order was 5-0. The FTC filed the complaint and proposed stipulated final order in the U.S. District Court for the District of Arizona on July 10, 2014. The proposed order is subject to court approval.

The Federal Trade 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. Settlement orders have the force of law when approved and signed by the District Court judge.

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.

Genetically customized nutritional supplements at the FTC's response to them

Some companies are pitching genetically customized nutritional supplements that will drop misleading disease claims, says the Federal Trade Commission (FTC). GeneLink, Inc. and a former subsidiary also agreed to improved safeguards of consumers’ sensitive medical information, says FTC's January 7, 2104 news release, "Companies Pitching Genetically Customized Nutritional Supplements Will Drop Misleading Disease Claims."

Two marketers of genetically customized nutritional supplements have agreed to settle Federal Trade Commission charges of deceptive advertising for claims that their personalized nutritional supplements treat diabetes, heart disease, arthritis, insomnia, and other ailments. The proposed settlements also resolve charges that the companies engaged in lax information security practices, accord to the Federal Trade Commission (FTC).

Through a network of individual affiliates, GeneLink, Inc. and its former subsidiary, foruTM International Corp., marketed nutritional supplements and a skincare product that were purportedly customized to each consumer’s unique genetic profile – based on an assessment of the DNA obtained from a cheek swab provided by the consumer. The supplements and skin repair serum each cost more than $100 per month.

The administrative complaint alleges that GeneLink and foru violated the FTC Act by making false or unsupported health claims about their genetically customized products. Company-approved marketing materials included claims that the customized nutritional supplements could compensate for an individual’s genetic disadvantages, and that the customized skin repair serum’s effectiveness was scientifically proven. The companies also claimed through testimonials that the customized nutritional supplements could treat serious conditions such as diabetes, heart disease, and insomnia.

According to the FTC, the companies also deceptively and unfairly claimed that they had taken reasonable and appropriate security measures to safeguard and maintain personal information collected from nearly 30,000 consumers

According to the complaint, the companies failed to protect the security of personal information – including genetic information, Social Security numbers, bank account information, and credit card numbers; did not require service providers to have appropriate safeguards for consumers’ personal information; and failed to use readily available security measures to limit wireless access to their network.

“This case is about the consequences of making false claims,” said Jessica Rich, Director of the FTC’s Bureau of Consumer Protection, according to the FTC's news release. “It doesn’t matter whether the claims deal with the benefits of direct-to-consumer genetic testing or the privacy of personal information. It’s against the law to deceive people about your product and to make promises you don’t keep.”

The proposed settlements prohibit the marketers from claiming that any drug, food, or cosmetic will treat, prevent, mitigate, or reduce the risk of any disease including diabetes, heart disease, arthritis, or insomnia – by modulating the effect of genes, or based on a consumer’s customized genetic assessment – unless the claim is true and supported by at least two adequate and well-controlled studies. The orders also require that claims that a product effectively treats or prevents a disease in persons with a particular genetic variation must be backed up with randomized clinical trials conducted on subjects who have that genetic variation.

In addition, the companies may not make any other claims about the health benefits, performance, or efficacy of any drug, food, or cosmetic by modulating the effect of genes, or the consumer’s customized genetic assessment – unless the claim is true and based on competent and reliable scientific evidence

The proposed orders also prohibit the marketers from misrepresenting scientific research regarding such drug, food, or cosmetic, or any genetic test or assessment. The orders also provide a safe harbor for advertising claims that have been approved by the FDA.

Under the proposed orders, GeneLink and foru also are prohibited from providing their affiliates, or any person or entity, with the means to make the prohibited health claims. The proposed settlements also require the companies to monitor claims their affiliates make on their behalf.

Finally, the proposed orders require the companies to establish and maintain comprehensive information security programs and submit to security audits by independent auditors every other year for 20 years. The proposed settlements also bar GeneLink and foru from misrepresenting their privacy and security practices.

These actions are part of the FTC’s ongoing efforts to stop over hyped health claims and protect the security of consumers’ sensitive health and financial information. Consumers should carefully evaluate health claims made by advertisers. The FTC has information for consumers about direct-to-consumer genetic tests and dietary supplements.

The Commission vote to accept the consent agreement package containing the proposed consent orders for public comment was 3-1, with Commissioner Ohlhausen voting no. Chairwoman Ramirez and Commissioner Brill have issued a joint statement, Commissioner Ohlhausen has issued a statement, and Commissioner Wright has issued a statement. The FTC will publish a description of the consent agreement package in the Federal Register shortly.

The agreements were subjected to public comment for 30 days, that began January 7, 2104 and continued through February 6, 2014, after which the Commission decided whether to make the proposed consent orders final. Interested parties were invited to submit written comments electronically or in paper form by following the instructions in the “Invitation To Comment” part of the “Supplementary Information” section, during those past dates. Comments in electronic form were submitted using the following Web links: FTC Comment Works (Genelink) and FTC Public Comment Works (foruTM International Corp.), and followed the instructions on the web-based form.

Comments in paper form were mailed or delivered to: Federal Trade Commission, Office of the Secretary, Room H-113 (Annex D), 600 Pennsylvania Avenue, N.W., Washington, DC 20580. The FTC also requested at that time back in January and February 2014 that any comment filed in paper form near the end of the public comment period could also have been sent by courier or overnight service, if possible, because U.S. postal mail in the Washington area and at the Commission is subject to delay due to heightened security precautions.

The Commission issues an administrative 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

When the Commission issues a consent order on a final basis, it carries the force of law with respect to future actions. Each violation of such an order may result in a civil penalty of up to $16,000, says the FTC's news release. 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 the number listed for filing complaints on its website. 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 the FTC on Twitter, and subscribe to press releases for the latest FTC news and resources.

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