FTC nails opiate withdrawal supplement company for misleading statements

Catlin Enterprises, Inc. (Catlin) is now barred from making scientifically unsubstantiated claims that their opiate withdrawal treatment alleviates withdrawal symptoms and increases the chances of overcoming opiate dependency. A Texas district court ordered the permanent injunction following the Federal Trade Commission’s (FTC) complaint against Catlin.

Complaint and order

The FTC alleged that Catlin falsely advertised its products Withdrawal Ease and Recovery Ease and participated in deceptive acts throughout the process of labeling, advertising, distribution, and sale of the products. According to Catlin’s statements, Withdrawal Ease significantly alleviates opiate withdrawal symptoms and significantly increases the likelihood of overcoming dependency, while Recovery Ease significantly alleviates post-acute withdrawal symptoms.

The injunction prevent Catalin and its officers, agents, employees, and other people actively participating in the company from engaging in any steps of the process of making and selling any dietary product intended to provide withdrawal assistance or other health benefits and represented as having such benefits unless such statements are not misleading. Any representation of benefits much be based on reliable scientific evidence, obtained from human clinical testing of the product or an equivalent product. The testing must be conducted by qualified researchers and be randomized, double-blind, and placebo controlled.

A $6.6 million judgment was entered and suspended premised upon the accuracy of sworn financial statements. Catalin must provide the FTC with customer information to allow the FTC to “administer consumer redress,” when requested, then destroy this information when instructed to do so by the FTC.

False promises rebuked by FDA, no tea or vitamin can cure cancer

Bogus cancer “treatments” being marketing and sold without FDA approval were the target of 14 warning letters and four online advisory letters, according to a press release and consumer update from the agency. The 65-plus products listed by the agency include pills, tablets, creams, syrups, sprays, oils, salves, teas, and medical devices, claiming to cure cancer in humans and pets, and have been found illegally for sale online, in retail stores, at flea markets and swap meets, and even at trade shows.

The FDA called these illegal products a “cruel deception,” and urged consumers to stay away from products that have not passed the agency’s review process, designed to ensure the safety and effectiveness of treatments. It listed the following phases or concepts as warning signs that the advertised product was unlikely to be approved by the agency:

  • treats all forms of cancer;
  • miraculously kills cancer cells and tumors;
  • shrinks malignant tumors;
  • selectively kills cancer cells;
  • more effective than chemotherapy;
  • attacks cancer cells, leaving healthy cells intact; or
  • cures cancer.

Additionally, many of the products that were the subject of the warnings were advertised as “natural” or “non-toxic.”

The warning and advisory letters ask the recipient companies to provide written responses to the violations covered in the letters; if the companies fail to respond and make adequate corrections, they could be subject to further actions including criminal prosecution. According to the FDA, the best scenario for consumers who have purchased or used these products is ineffectiveness. It is possible, however, that these products could interfere with proven, beneficial treatments, or even cause direct harm.

CogniPrin and FlexiPrin supplement marketers charged by FTC and Maine AG

The Federal Trade Commission (FTC) and the Attorney General (AG) of Maine have filed a complaint against nine dietary supplement marketers, including three corporations and six individuals, for their roles in a deceptive campaign to sell a joint health supplement (FlexiPrin) and a cognitive health supplement (CogniPrin) in violation of state and federal laws. The FTC and Maine AG have also jointly announced that six of the marketers (two corporations and four individuals) have agreed to settlements, in the form of proposed stipulated orders, with the state and federal governments.

Complaint

The FTC and the Maine AG allege that XXL Impressions LLC, Jeffrey R. Powlowsky, J2 Response LLP, Justin Bumann, Justin Steinle, Synergixx, LLC, Charlie Fusco, Ronald Jahner, and Brazos Minshew made false and misleading claims that the supplement CogniPrin:

  • reverses mental decline by 12 years;
  • improves memory by 44 percent; and
  • improves memory in as little as three weeks and is clinically proven to improve memory.

And that the supplement FlexiPrin:

  • reduces joint and back pain, inflammation, and stiffness in as little as two hours;
  • rebuilds damaged joints and cartilage; and
  • has been clinically proven to reduce the need for medication in 80 percent of users and to reduce morning joint stiffness in all users.

The complaint alleges that the marketers employed unfair or deceptive acts or practices in the advertising, marketing, distribution, and sale of FlexiPrin and CogniPrin. The marketers also allegedly sold these products directly to consumers, primarily through radio and print advertising nationwide and in Canada, which garnered in excess of $6.5 million in gross sales from January 1, 2012 through April 30, 2015. The complaint specifically alleges that the defendants:

  • made false claims about the efficacy and testing of their products;
  • deceptively enrolled consumers in continuity plans, or automatic monthly shipments for which consumers’ credit and debit cards were automatically charged;
  • when consumers attempted to halt shipments or obtain a refund, they were then told of additional, undisclosed requirements they could almost never abide by;
  • would use stage names and claim medical credentials to promote the products and claim clinical testing that never actually occurred; and
  • deceptively induced consumers to purchase other services such as discount buying clubs or health savings plans which were also difficult to cancel.

Proposed stipulated orders

Marketers Powlowsky, XXL Impressions, J2Response, Bumann, and Steinle have agreed in two proposed court orders to substantial injunctions against making unsubstantiated health efficacy claims. A stipulated order against J2Response, Bumann, and Steinle and a second stipulated order against Powlowsky and XXL Impressions LLC both bar these marketers from making the false or unsubstantiated heath claims challenged in the complaint and require them to have competent and reliable scientific evidence when making health-related claims. The orders also requires these marketers to preserve all scientific evidence supporting claims they make, and bar them from failing to disclose a material connection to a paid endorser. The orders further bar these marketers from misrepresenting the terms of any negative-option, continuity plans, or free trial offers, and require them to get consumers’ express consent before charging them.

In addition, the stipulated order against Powlowsky and XXL Impressions LLC bans them from direct response marketing of foods, dietary supplements, or drugs for 20 years, while allowing the former to continue his manufacturing brokering business.

The stipulated order against Minshew bars him from acting as an “expert endorser” unless he has the expertise he claims to have, and requires him to have scientific evidence to support the product claims he makes.

The stipulated orders impose a $6.57 million judgment against the marketers, with all but $556,000 suspended due to their inability to pay. The stipulated final orders will have the force of law if and when approved and signed by a district court judge upon deciding the case.

The litigation continues as to Fusco, Synergixx, LLC, and Jahner.

FTC gives consumers scammed by green coffee extract their money back

The Federal Trade Commission (FTC) is mailing more than $9 million in refund checks to 191,748 consumers who purchased Pure Health or Genesis Today green coffee bean extract weight-loss supplements online. The online consumers will receive a full refund for the cost of the supplements—the average refund check will total $47.93. Consumers who purchased the supplements through retail stores (Walmart) will not receive a check through the FTC mailing. Those consumers may be eligible for a partial refund. However, to receive the refund, the retail consumers must fill out a claim form.

Settlement

The refund arises from a January, 2015 settlement resolving allegations that the owner of Pure Health and Genesis Today deceptively marketed the weight loss benefits of the green coffee bean extract. The deceptive claims included assertions that green coffee been extract can cause significant and rapid weight loss. Specifically, the FTC charged the owner with stating that “the supplement could cause consumers to lose 17 pounds and 16 percent of their body fat in just 12 weeks without diet or exercise, and that the claim was backed up by a clinical study.” Under the settlement, the owner was prohibited from making deceptive claims about dietary supplements or drug products. Additionally, the owner agreed to pay $9 million for consumer redress (see Green Coffee supplement marketer loses more than weight in $9M settlement, Health Law Daily, January 27, 2015).

Refunds

The refund checks were mailed on June 14, 2016. Consumers have 60 days to cash the checks or they will become void. To avoid fraud, the FTC warned consumers that the FTC never requires consumers to pay money or provide information before a refund check can be cashed.