Source : 'HBW Insight'
Looser manufacturing standards the US Food and Drug Administration allowed to spur production of hand sanitizers during the coronavirus pandemic combined with its lack of authority to order drug recalls could be linked to some sanitizers containing methanol remaining available while others are being recalled.
The agency on 2 July updated its notifications about hand sanitizer labeled as containing ethyl alcohol, or ethanol, but contaminated with methanol, or wood alcohol, with an announcement that some distributors are voluntarily recalling the products. The manufacturer, Mexico firm Eskbiochem SA de CV, though, has not responded to the agency’s request to recall its products marketed in the US under multiple brands.
“The agency is aware of adults and children ingesting hand sanitizer products contaminated with methanol that has led to recent adverse events including blindness, hospitalizations and death,” according to the update on the contaminated hand sanitizers.
All-clean and saniderm, made by eskbiochem, above, and bersih made by Soluciones Cosmeticas, below, are among the hand sanitizers available in the us found to contain methanol.
Fatalities linked to methanol-contaminated hand sanitizers that the FDA is aware of likely include three reported in New Mexico. The state Department of Health on 26 June announced that seven people in New Mexico are believed to have drunk hand sanitizer with methanol and three died.
Another person who drank hand sanitizer in New Mexico is permanently blind and three others were in critical condition, the state agency said.
Previously, the FDA said it contacted Eskbiochem on 17 June to recommend the company remove its hand sanitizer products from the market due to the risks associated with methanol poisoning but “the company has not taken action to remove these potentially dangerous products from the market.”
On 29 June, the agency announced that two firms are recalling Saniderm brand hand sanitizers they distribute that are made by Eskbiochem. Corona, CA, firm UVT Inc. and Saniderm Medial LLC, of Lehi UT, are 1-liter bottles labeled with “Made in Mexico” and “Produced by: Eskbiochem SA de CV.”
According to the FDA’s latest announcement, five other hand sanitizer brands also made by Eskbiochem are recommended for recall but are not yet being recalled by distributors: All-Clean, Esk Biochem, Lavar 70 Gel, The Good Gel Antibacterial Gel and CleanCare NoGerm Advanced 75% and 80% alcohol formulations.
Additionally, products made by four other firms in Mexico were found by the FDA to be contaminated with methanol and on 1 July were recommended for recall:
Grupo Insoma S.A.P.I de CV, Hand Sanitizer Gel Unscented 70% alcohol;
Transliquid Technologies, Mystic Shield Protection hand sanitizer;
Soluciones Cosmeticas SA de CV, Bersih Hand Sanitizer gel fragrance free and Antiseptic Alcohol 70% Topical Solution hand sanitizer;
Tropicosmeticos SA de CV, Britz Hand Sanitizer Ethyl Alcohol 70%.
While the FDA is testing hand sanitizers for methanol and warning consumers not to use products found to be contaminated and also not to ingest any sanitizers, members of Congress and other critics of the agency’s pharmaceutical industry oversight likely will say the problem is the latest sign that the FDA should have authority to impose mandatory recalls on drug products.
As the FDA in late 2019 and earlier in 2020 determined whether OTC and Rx drugs containing the antacid ranitidine should remain available due to the potential for a nitrosamine impurity and potential carcinogenic to develop organically in the products, Rep. Rosa DeLauro re-introduced legislation proposing that the agency have mandatory recall authority for drugs. ("DeLauro Renews Push To Give FDA Mandatory Recall Authority For Drugs" "HBW Insight" )
The agency has mandatory recall authority for food products, including dietary supplements, under the Food Safety Modernization Act Congress passed in 2010. However, it does not have authority to order recalls of drugs, including OTC as well as Rx products, and of medical devices.
Meanwhile, the number of firms providing hand sanitizers available in the US has expanded since the FDA in March, to help meet soaring demand due to the COVID-19 pandemic, published guidance allowing "significant flexibility" for making nonprescription sanitizers to allow manufacturing that might otherwise get sanctioned for marketing adulterated drugs. It noted that consumers were experiencing difficulties accessing alcohol-based hand sanitizers and were making their own, which could be unsafe. ("Hand Sanitizers Offered In Liquor Bottles Among Emerging Concerns Under US FDAs Pandemic Rule" "HBW Insight" )
About a month after the guidance’s publication, the agency in late April reported finding hand sanitizers with noncompliant labels and formulations and marketed with violative claims to appeal to consumers' fears about preventing or treating COVID-19. It said more than 1,500 additional manufacturers had registered to produce hand sanitizer.
In its latest statement on the contaminated products, the FDA says it is testing hand sanitizers, including products entering the country through the US border. It also is listing agency-tested and recalled sanitizers on it website and is updating the list as "dangerous products are discovered."
Methanol primarily is produced industrially by hydrogenation of carbon monoxide and is converted to formaldehyde. Light, volatile, colorless and flammable with a distinctive alcoholic odor, it is known also as wood alcohol because it once was made chiefly through destructive distillation of wood.
Applying methanol to skin creates the same risks as ingestion, though not as high, of nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death.
By Malcolm Spicer