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Consumer Health Digest #24-13
March 31, 2024
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; other news items; Web site evaluations; recommended and nonrecommended books; research tips; and other information relevant to consumer protection and consumer decision-making. The Digest’s primary focus is on health, but occasionally it includes non-health scams and practical tips. Items posted to this archive may be updated when relevant information becomes available. To subscribe, click here
http://lists.quackwatch.org/mailman/listinfo/chd_lists.quackwatch.org.
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FDA warns about pain-relief products containing excessive drug dosesThe U.S. Food and Drug Administration (FDA) is warning consumers not to use certain over-the-counter analgesic (pain relief) products marketed for use on the skin to relieve pain before, during, or after cosmetic procedures such as microdermabrasion, laser hair removal, tattooing and piercing.
[FDA warns consumers to avoid certain topical pain relief products due to potential for dangerous health effects
https://www.fda.gov/news-events/press-announcements/fda-warns-consumers-avoid-certain-topical-pain-relief-products-due-potential-dangerous-health. FDA news release, March 26, 2024]
Some of these products are labeled to contain ingredients such as lidocaine at concentrations higher than what is permitted for over-the-counter, topical pain-relief products. The FDA is aware of reports of adverse events related to these products. When these products are applied in ways that could lead to increased absorption through the skin, they can result in serious injury such as irregular heartbeat, seizures, and breathing difficulties. These products may also interact with medications or dietary supplements a consumer is taking. The FDA has issued warning letters for marketing these products in violation of federal law to six companies:
TKTX Company
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tktx-company-673879-03252024: TKTX Numb Maximum Strength Pain Reliever, Mithra+ 10% Lidocaine, TKTX During Procedure Numbing Gel 40%, and J-CAIN cream
[LIDOCAINE]
29.9%
SeeNext Venture, Ltd.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/seenext-venture-ltd-674915-03252024: NumbSkin 5% Lidocaine Numbing Cream (15 grams), NumbSkin 5% Lidocaine Numbing Cream (30 grams), and NumbSkin 10.56% Lidocaine Numbing Cream
Tattoo Numbing Cream Co.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tattoo-numbing-cream-co-672467-03252024: Signature Tattoo Numbing Cream and Miracle Numb Spray
Sky Bank Media, LLC, doing business as Painless Tattoo Co.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sky-bank-media-llc-dba-painless-tattoo-cream-co-666693-03252024: Painless Tattoo Numbing Cream and Painless Tattoo Numbing Spray
Dermal Source, Inc.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/dermal-source-inc-663632-03252024: New & Improved Blue Gel, Superior Super Juice, Premium Pro Plus, Five-Star Vasocaine, and Maximum Zone 1
Indelicare, doing business as INKEEZE
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/indelicare-dba-inkeeze-671656-03252024: INKEEZE Original B Numb Numbing Gel, INKEEZE B Numb Numbing Spray Black Label, and INKEEZE B Numb Numbing Foam Soap
The FDA has warned consumers
https://wayback.archive-it.org/7993/20171115192013/https:/www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm110625.htm about similar products over the past decade. It recommends against:
using over-the-counter (OTC) pain-relief products with more than 4% lidocaine on the skin
applying OTC pain-relief products heavily over large areas of skin or to irritated or broken skin
wrapping skin treated with OTC pain-relief products with plastic wrap or other dressings, which can increase the chance of serious side effects
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Researchers raise doubts about CBD products promoted for pain reliefBased on their literature review of cannabidiol (CBD) products’ purity, harmful effects, and effectiveness, researchers from the U.K. and the University of Alberta have concluded: “For people living with pain, the evidence for CBD or hemp extract shows it is expensive, does not work, and is possibly harmful.”
[Moore A, and others. Cannabidiol (CBD) products for pain: Ineffective, expensive, and with potential harms
https://www.sciencedirect.com/science/article/pii/S1526590023005825. The Journal of Pain, 25(4):833-842, 2024]
Their key findings were:
CBD products have varying amounts of CBD, from none to much more than advertised.
CBD products may contain other chemicals that may be harmful.
Out of 16 randomized clinical trials for pain using pharmaceutical CBD in oral, buccal/sublingual, and topical forms, 15 found no greater pain-relieving effect for CBD than for placebo.
Meta-analyses link CBD to increased rates of serious adverse events and liver toxicity.
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FDA criticized for settling lawsuit by ivermectin-misinformation promotersBusiness columnist Michael Hiltzik has criticized the FDA for settling a lawsuit
https://storage.courtlistener.com/recap/gov.uscourts.txsd.1875135/gov.uscourts.txsd.1875135.1.0_1.pdf brought by three physicians in 2022 claiming the FDA’s advisories improperly discouraged the use of the anti-parasite drug ivermectin for treating or preventing COVID-19.
[Hiltzik M. FDA shoots itself in the foot by settling a groundless lawsuit over its ivermectin warnings
https://www.latimes.com/business/story/2024-03-26/column-the-fda-shoots-itself-in-the-foot-by-settling-a-dumb-lawsuit-over-ivermectin. Los Angeles Times, March 26, 2024]
The agency settled the case by agreeing to delete
https://s3.documentcloud.org/documents/24495557/fda-stipulation-of-dismissal.pdfthree social media posts and a consumer advisory titled “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19
https://nycourts.gov/reporter/webdocs/Why-You-Should-Not-Use-Ivermectin-to-Treat-or-Prevent-COVID-19.pdf.” A federal judge in Texas had thrown out their case
https://storage.courtlistener.com/recap/gov.uscourts.txsd.1875135/gov.uscourts.txsd.1875135.45.0_2.pdf, but the 5th Circuit Court of Appeals reinstated it last year,
https://storage.courtlistener.com/recap/gov.uscourts.ca5.211456/gov.uscourts.ca5.211456.65.1.pdf returning it to the original judge for reconsideration. Hiltzik reported the FDA said it chose to resolve this lawsuit rather than continuing to litigate over statements that are between two and nearly four years old. Hiltzik called the settlement a blunder, however, because:
“It leaves on the books the 5th Circuit’s adverse ruling, in which a panel of three judges found that the FDA’s advisory crossed the line from informing consumers, which they said is all right, to recommending that consumers take some action, which they said is not all right.”
The 5th Circuit’s ruling was a misinterpretation of the law, which might be used to litigate against the FDA for:
current consumer advisories such as “Don’t believe the hype
https://www.fda.gov/consumers/consumer-updates/fda-warns-about-stem-cell-therapies. . . Some unscrupulous providers offer stem cell products that are both unapproved and unproven. So, beware of potentially dangerous procedures.”
future advisories that discourage product misuse.
Unwary consumers may be misled by announcements from the plaintiffs’ camp, such as:
“‘The FDA loses its war on ivermectin”
the case was about “FDA overreach into the doctor–patient relationship.”
a tweet posted by Bowden
https://twitter.com/MdBreathe/status/1771023714584273015 endorsed by Robert F. Kennedy, Jr., a leading source of healthcare disinformation
https://www.latimes.com/business/story/2023-06-19/column-robert-f-kennedy-jr-is-not-only-a-threat-to-your-health-but-a-threat-to-our-democracy.
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Lawsuit alleges Women’s Cancer Fund is sham charityThe Federal Trade Commission and 10 states are suing Cancer Recovery Foundation International (also known as Women’s Cancer Fund) and its operator, Gregory B. Anderson, for deceiving donors. The 10 states are California, Florida, Maryland, Massachusetts, North Carolina, Oklahoma, Oregon, Texas, Virginia, and Wisconsin.
[FTC, 10 states take action against operator of sham cancer charity for deceiving donors
https://www.ftc.gov/news-events/news/press-releases/2024/03/ftc-10-states-take-action-against-operator-sham-cancer-charity-deceiving-donors. FTC press release, March 11, 2024]
The government’s complaint
https://www.ftc.gov/system/files/ftc_gov/pdf/ECF1-COMPLAINTagainstCRFIAnderson-filed4.24-cv-00881.pdf, filed in federal court, alleges:
Between 2017 and 2022, Women’s Cancer Fund collected more than $18.25 million from donors, promising donors their gift would go to directly help cancer patients and their families who were in need and assist them with basic living expenses such as rent, utilities, and food for their children. Instead, however, the overwhelming majority of the donations benefited Anderson and the for-profit fundraisers he hired.
Only $194,809—roughly 1%— was spent directly on helping women with cancer, while Anderson paid himself over $775,139 and paid the for-profit fundraisers he worked with over $15.55 million (85% of the total raised). The remaining amount went to paying for defendants’ overhead expenses.
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Stephen Barrett, M.D.
Consumer Advocate
7 Birchtree Circle
Chapel Hill, NC 27517
Telephone: (919) 533-6009
http://www.quackwatch.org (health fraud and quackery)
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