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Author Topic: Warnings issued against illegally marketing products for Alzheimer's disease  (Read 345 times)

Krik

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Consumer Health Digest #19-07
February 17, 2018

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.

###
Warnings issued against illegally marketing products for Alzheimer's disease

The U.S. Food and Drug Administration (FDA) has posted 12 warning letters and 5 online advisory letters issued to foreign and domestic companies that are illegally selling products with unsubstantiated claims that they prevent, treat or cure Alzheimer's disease and, in some cases, other serious health problems.
[FDA takes action against 17 companies for illegally selling products claiming to treat Alzheimer's disease
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm631064.htm
. FDA News Release. Feb 11, 2019]

Three other warnings were send jointly by the FDA and FTC.
[FTC and FDA send warning letters to companies selling dietary supplements claiming to treat Alzheimer's disease and remediate or cure other serious illnesses such as Parkinson's, heart disease, and cancer
https://www.ftc.gov/news-events/press-releases/2019/02/ftc-fda-send-warning-letters-companies-selling-dietary
 FTC Press Release. Feb 11, 2019]

Although most of the products were marketed as dietary supplements, the disease-related claims subjected them to regulation as misbranded and/or unapproved new drugs.

Warning letters went to:

Gold Crown Natural Products
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm630539.htm

, Peak Nootropics LLC (aka Advanced Nootropics)
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm630753.htm

, DK Vitamins
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm630531.htm

, Sovereign Laboratories LLC
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm630558.htm

,  Blue Ridge Silver
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm630568.htm

, Nutrition Coalition Inc
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm630529.htm

, John Gray's Mars Venus LLC
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm630570.htm

, TEK Naturals
ttps://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm630654.htm

, Earth Turns LLC
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm630564.htm

, Emmbros Overseas Lifestyle PVT LTD
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm630619.htm

, Pure Nootropics LLC
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm630486.htm
, and

Capris Associates Inc. / BR Naturals
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm630588.htm

Advisory letters went to:

Alzheimer's Corporation (ALZcorp)
https://www.fda.gov/ICECI/EnforcementActions/AdvisoryLetters/ucm630343.htm

, Alzheimer's Organization
https://www.fda.gov/ICECI/EnforcementActions/AdvisoryLetters/ucm630842.htm

 Dr. Fitt Intelligent Designs LLC
https://www.fda.gov/ICECI/EnforcementActions/AdvisoryLetters/ucm630843.htm

 Healthcare Products LLC d/b/a The Alzheimer's Store d/b/a MindCare Store
https://www.fda.gov/ICECI/EnforcementActions/AdvisoryLetters/ucm630341.htm
 and

This Wonderful Life New Age Shop
https://www.fda.gov/ICECI/EnforcementActions/AdvisoryLetters/ucm628874.htm

The joint warnings went to

Gold Crown Natural Products
https://www.ftc.gov/system/files/attachments/press-releases/ftc-fda-send-warning-letters-companies-selling-dietary-supplements-claiming-treat-alzheimers-disease/gold_crown_natural_products_warning_letter_wl_566223.pdf

, TEK Naturals
https://www.ftc.gov/system/files/attachments/press-releases/ftc-fda-send-warning-letters-companies-selling-dietary-supplements-claiming-treat-alzheimers-disease/tek_naturals_warning_letter_wl_565026.pdf
, and

Pure Nootropics, LLC
https://www.ftc.gov/system/files/attachments/press-releases/ftc-fda-send-warning-letters-companies-selling-dietary-supplements-claiming-treat-alzheimers-disease/pure_nootropics_llc_warning_letter_wl_565425.pdf
.
The FDA's total for the past five years includes more than 40 companies that promoted more that 80 products with illegal Alzheimer's disease claims on Web sites, on social media, and in stores.

###
27 BC naturopaths facing disciplinary action for dubious ads

The College of Naturopathic Physicians of British Columbia (BC) has placed 27 out of 593 practicing registered naturopaths
https://www.naturowatch.org/
 in BC under investigation as part of its crackdown on misleading advertising
https://www.cnpbc.bc.ca/advertising-enforcement/
. The College expects to seek fines of $500 per infraction in addition to other sanctions.
[Lindsay B. 27 B.C. naturopaths under investigation as college cracks down on misleading ads
https://www.cbc.ca/news/canada/british-columbia/27-bc-naturopaths-college-advertising-crackdown-1.4987191
. CBC News. Jan 22, 2019]

###
Misinformation about prostate cancer found in YouTube videos

A multinational team of researchers has concluded that many popular YouTube videos about prostate cancer contain poor-quality information. The researchers concluded:

YouTube is a social media platform with more than 1 billion users and > 600 000 videos about prostate cancer. Two small studies examined the quality of prostate cancer videos on YouTube, but did not use validated instruments, examine user interactions, or characterize the spread of misinformation. We performed the largest, most comprehensive examination of prostate cancer information on YouTube to date, including the first 150 videos on screening and treatment. We used the validated DISCERN quality criteria for consumer health information and the Patient Education Materials Assessment Tool, and compared results for user engagement. The videos in our sample had up to 1.3 million views (average 45,223) and the overall quality of information was moderate. More videos described benefits (75%) than harms (53%), and only 50% promoted shared decision-making as recommended in current guidelines. Only 54% of the videos defined medical terms and few provided summaries or references. There was a significant negative correlation between scientific quality and viewer engagement. . . . The comments section underneath some videos contained advertising and peer-to-peer medical advice. A total of 115 videos (77%) contained potentially misinformative and/or biased content within the video or comments section, with a total reach of >6 million viewers. . . . A greater number of views and thumbs up on YouTube does not mean that the information is trustworthy.

[Loeb S. and others. Dissemination of misinformative and biased information about prostate cancer on YouTube
https://www.ncbi.nlm.nih.gov/pubmed/30502104
. European Urology, in press]
An acompanying editorial urged physicians to engage more on social media to point the public to reliable sources and criticize sites that are providing misinformation.
[Carneiro B, Dizon DS. Prostate cancer social media: In YouTube we trust
https://www.europeanurology.com/article/S0302-2838(19)30005-3/abstract
? European Urology, In press]

###
Doctors group calls for end to France's homeopathy reimbursements

Le Collège National des Généralistes Enseignants (CNGE), which represents generalist physicians in France, has called for an end to reimbursements (currently at 30%) by France's national health insurance system for homeopathic medicine
https://www.homeowatch.org/
. The organization said: "There is no way to justify the reimbursement of these 'medicines'. There is not even any justification for teaching this kind of practice at university."
[French GPs call for stop to homeopathy reimbursement
https://www.connexionfrance.com/French-news/French-GPs-call-for-stop-to-homeopathy-reimbursement-by-Assurance-Maladie-as-debate-rages-on
. Connexion. Jan 11, 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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