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Aktuell im WWW => *** PRESSEMELDUNGEN *** => Topic started by: Krik on April 24, 2019, 05:19:07 AM
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Consumer Health Digest #19-16
April 21, 2019
Consumer Health Digest is a free weekly e-mail newsletter edited by William M. London, Ed.D., M.P.H
http://www.calstatela.edu/faculty/william-m-london
., with help from Stephen Barrett, M.D
http://www.quackwatch.org/10Bio/bio.html
. 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.
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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
https://www.fda.gov/Food/DietarySupplements/ProductsIngredients/ucm636077.htm
as dietary supplements:
Atomixx
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm635787.htm
, Evol Nutrition Associates, Inc.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm635781.htm and
NeuroScience Solutions, Inc. dba NeuroScience
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm635784.htm
eight marketers of products labeled to contain DMHA
https://www.fda.gov/Food/DietarySupplements/ProductsIngredients/ucm636032.htm
as dietary supplements:
Line One Nutrition
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm635809.htm
, Iron Brothers Supplements
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm635821.htm
, Eflow Nutrition LLC
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm635816.htm
Hi-Tech Pharmaceuticals, Inc.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm635811.htm
IQ Formulations, LLC / DBA Metabolic Nutrition Inc.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm635801.htm
, Down To Earth Solutions, LLC
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm635837.htm
, Forbidden Labz
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm635866.htm , and
Total Body Nutrition Labs, LLC
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm635909.htm
[FDA acts on dietary supplements containing DMHA and phenibut
https://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm636082.htm
. 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."
https://sciencebasedmedicine.org/phenibut-is-neither-proven-nor-safe-as-a-prosocial-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
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5836053/
. 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
https://www.fda.gov/Food/DietarySupplements/ProductsIngredients/ucm636081.htm
###
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
http://www.quackwatch.org/01QuackeryRelatedTopics/Naturopathy/immu.html
. 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
http://www.naturowatch.org/immu/sensenig.shtml
. 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
https://www.ftc.gov/system/files/documents/cases/geniux_complaint_4-10-19.pdf
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-Z
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
https://www.ftc.gov/system/files/documents/cases/proposed_stip_j_and_order_gci_ds_4-10-19.pdf
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
https://www.ftc.gov/system/files/documents/cases/proposed_stip_j_and_order_phs_ds_4-10-19.pdf
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
https://www.ftc.gov/news-events/press-releases/2019/04/geniux-dietary-supplement-sellers-barred-unsupported-cognitive
. FTC Press Release. Apr 10, 2019]
=================================
Stephen Barrett, M.D.
Consumer Advocate
287 Fearrington Post
Pittsboro, NC 27312
Telephone: (919) 533-6009
http://www.quackwatch.org (health fraud and quackery)
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