Consumer Health Digest #19-16ß
Your Weekly Update of News and Reviews
April 21, 2019
Consumer Health Digest is a free weekly e-mail newsletter edited by William M. London, Ed.D., M.P.H., with help from Stephen Barrett, M.D. It summarizes scientific reports; legislative developments; enforcement actions; news reports; Web site evaluations; recommended and nonrecommended books; and other information relevant to consumer protection and consumer decision-making. Its primary focus is on health, but occasionally it includes non-health scams and practical tips.
Marketers of phenibut and DMHA products warned. The U.S. Food and Drug Administration (FDA) has issued warning letters to:
- three marketers of products labeled to contain phenibut as dietary supplements: Atomixx, Evol Nutrition Associates, Inc., and NeuroScience Solutions, Inc. dba NeuroScience
- eight marketers of products labeled to contain DMHA as dietary supplements: Line One Nutrition, Iron Brothers Supplements, Eflow Nutrition LLC, Hi-Tech Pharmaceuticals, Inc., IQ Formulations, LLC / DBA Metabolic Nutrition Inc., Down To Earth Solutions, LLC, Forbidden Labz, and Total Body Nutrition Labs, LLC
[FDA acts on dietary supplements containing DMHA and phenibut. FDA Constituent Update. Apr 16, 2019]
Phenibut is a designer drug used to treat anxiety, insomnia, and other conditions in several Eastern European countries. Evidence is lacking for its safety and effectiveness for even though it has been promoted as "the Russian wonder drug." It is not approved for clinical use in the U.S. The FDA has concluded that phenibut does not meet the statutory definition of a dietary ingredient and that any dietary supplement that declares phenibut as a dietary ingredient would be misbranded. DMHA has been misleadingly marketed on the Internet as a "safe and legal" analogue of banned stimulant drugs. The FDA considers dietary supplements containing DMHA to be adulterated because DMHA is either an unsafe food additive or a "new dietary ingredient" (not lawfully marketed as a dietary supplement in the U.S. before October 15, 1994) for which the FDA has not received the required New Dietary Ingredient notification. The FDA has updated its list of dietary supplement ingredients that do not appear to be lawful.
Naturopathic views on immunization spotlighted. Dr. Stephen Barrett has posted two articles about naturopathic opposition to immunization. One places the views in historical perspective. [Barrett S. Naturopathic opposition to immunization. Quackwatch, April 22, 2019] The other rebuts antivaccination claims made by a prominent naturopathic educator. [Barrett S. Naturopathic nonsense about immunization: A response to Jim Sensenig, N.D. Naturowatch, April 21, 2019]
Supplement sellers barred from brain-boosting claims. The Federal Trade Commission (FTC) has announced that twelve corporate and four individual defendants have settled charges that they:
- deceptively marketed "cognitive improvement" supplements using sham Web sites containing false and unsubstantiated efficacy claims, references to non-existent clinical studies, and fraudulent consumer and celebrity endorsements.
- used affiliate marketers to make deceptive claims about their products, which they sold using different names, including Geniux, Xcel, EVO, and Ion-
- made false or unsupported claims online about the Geniux products' ability to improve short- and long-term memory, increase focus, increase concentration, prevent memory loss, boost brain power, and improve users' speed of information processing
- falsely advertised that scientists were calling their "Smart Pill 'Viagra for the Brain,'" and that it should be "taken as directed for extreme IQ effects"
- falsely advertised that Geniux products had been tested in over 2,000 clinical trials and that scientific studies proved the Geniux products increase users' focus "by up to 121%," "sky-rocket concentration by 32%," and boost brain power, memory recall, and IQ
- failed to honor advertised money-back guarantees
- charged for products that consumers never received
The FTC also alleged that the defendants made the challeged claims on their own Web sites, as well as through the sites of at least 36 third-party affiliate networks. Some sites were deceptively formatted to look like—but were not—real news sites. Some sites included fake consumer endorsements.
The Commission has approved two separate proposed orders settling the FTC's charges. The first order resolves the allegations against individual defendants Fred Richard Guerra, III; Lanty Paul Gray, Jr.; and Rafat Abbas, as well as corporate defendants Global Community Innovations LLC; Innovated Health LLC; Emerging Nutrition Inc.; Buddha My Bread LLC; Innovative Fulfillment LLC; Ship Smart LLC; Vista Media LLC; Ash Abbas LLC; DCT Marketing, Inc.; and RNA Enterprise, Inc. The second order resolves the allegations against individual defendant Robby O. Salaheddine, and corporate defendants Premium Health Supplies, LLC and ROS Marketing & Consulting LLC. The proposed orders bar the defendants making unsubstantiated claims for their products and refusing to allow returns or order cancellations. Guerra, Gray, Abbas, and Salaheddine are also required to $243,000, $100,000, 100,000 and $180,000, respectively, or much larger amounts if it is later found that they misrepresented their ability to pay. [Geniux dietary supplement sellers barred from unsupported cognitive improvement claims. FTC Press Release. Apr 10, 2019]
This page was revised on April 23, 2019