FDA seeks comments on regulation of kratom, 6 other drugs

2021-08-04

Kratom, a popular but unregulated psychotropic herbal extract, is one of seven currently unscheduled psychotropic drugs that will be reviewed by the World Health Organization (WHO) under the provisions of the international psychotropic convention to which the US is a party.

WHO notified the US and other international parties to the 1971 convention that the seven new psychotropic drugs may be added to its list of scheduled drugs. By law, that notification triggers a requirement that the secretary of the US Department of Health and Human Services (HHS) publish a request for comments in the Federal Register.

These substances “have never been formally reviewed by WHO and are not currently under international control,” wrote WHO in notifying the US and other nations of its intent to review the drugs. “Information was brought to WHO’s attention that these substances are clandestinely manufactured, of especially serious risk to public health and society, and of no recognized therapeutic use.”

Two novel synthetic opioids, brorphine and metonitazene, are scheduled for review at the October meeting of WHO’s expert committee on drug dependence (ECDD). The synthetic cannabinoid receptor agonist 4F-MDMB-BICA, or 4F-MDMB-BUTICA, is also scheduled for review.

Two “designer drugs” that function as stimulants, eutylone or bk-EBDB, and BMDP, are also up for review by ECDD. BMDP’s chemical name is 3,4-Methylenedioxy-N-benzylcathinone and it is also known as benzilone.

Kratom, along with its two active substances, mitragynine and 7-hydroxymitragynine, are in pre-review status, according to WHO. The pre-review process determines whether sufficient evidence exists to bring the substance before the ECDD for a formal review; “findings at this stage should not determine whether the control status of a substance should be changed,” according to the WHO notification.

One medicine, phenibut (beta-phenyl-gamma-aminobutyric acid HCl), is also in pre-review. Phenibut is currently used in Russia to treat alcohol withdrawal, as well as anxiety, insomnia and vestibular disorders, according to the Federal Register notification. It has no medical use in the US but is available online without a prescription.

The ECDD’s meetings, at which the group “conducts medical, scientific, and public health evaluations of the selected psychoactive substances using the best available information,” are closed to the public, but WHO member states may participate in an ECDD open session slated for 11 October.

Member states are asked to complete a questionnaire about the substances under review, so EDCC can form an assessment on the status and current use patterns of the drugs in each country. Member states can also provide additional relevant information.

According to the 19 July Federal Register notice, the US Food and Drug Administration (FDA) plans to defer any recommendations regarding whether the drugs should be moved to a controlled class until WHO makes official recommendations to its Commission on Narcotic Drugs.

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~tVolatile compounds from personal products drive urban ozone chemistry

Emissions from products like deodorant and lotion played a major role in 2018 high ozone levels in New York.

Personal care products like deodorant and lotion contain volatile organic compounds (VOCs) that add fragrance or texture—and these can be emitted into the air. Now, research suggests that in densely populated areas, these emissions have significant implications for air quality. During summer 2018, volatile chemical products played just as important a role in driving high ozone pollution levels in New York City as did volatile organic compounds (VOCs) produced by fossil fuel burning (Proc. Natl. Acad. Sci. USA 2021, DOI: 10.1073/pnas.2026653118).

Ground-level ozone is a respiratory irritant and results when nitrogen oxides, mostly from vehicle tailpipes, react with VOCs in the presence of sunlight. Historically, most of those VOCs, such as benzene, have also come from fossil fuel combustion. VOCs such as pinene and limonene emitted by forests in the summer can also drive ozone chemistry. Decades of regulation have reduced vehicle emissions and have led to better air quality, says Matthew Coggon, an atmospheric chemist at the National Oceanic and Atmospheric Administration and a leader of the research. “But we still have ozone exceedances in megacities. What’s the cause?”

Chemists have been examining the role of volatile chemical products in ozone formation since the 1990s. These compounds, he says, are petrochemicals, and are found in a huge variety of products, including industrial solvents and personal care products. But Coggon says figuring out the importance of these compounds relative to VOCs from other sources has been challenging without sensitive measurements.

Coggon and his team drove a mobile lab, equipped with a proton transfer reaction time-of-flight mass spectrometer, around American cities including New York and Chicago, and European cities including Bern and Vienna. The team used relative ratios of tracer molecules to assign VOC signatures to different sources. High levels of benzene meant measured volatiles were likely a product of fossil fuel combustion. And high levels of decamethylcyclopentasiloxane (D5-siloxane), whose primary sources are antiperspirants and hair care products, meant other associated volatiles were also probably from personal care products. Volatile personal care product emissions, Coggon says, were correlated with population density.

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~sc&en, 4 August 2021

~shttps://cen.acs.org/environment/atmospheric-chemistry/Volatile-compounds-personal-products-drive/99/i29

~tOur view: Feds should limit ‘forever chemicals’

If failed or nonexistent policies to protect people from the spread of COVID-19 around the country weren’t a potent enough example of the consequences of leaving science and health policy to the states, consider the dangers posed by per- and polyfluoroalkyl substances.

The synthetics widely used in manufacturing since World War II, in both stains and stain-resistant treatments, accumulate in the body. They are tied to a litany of health problems, such as pregnancy complications and thyroid disease. But unlike litter gathered on the roadside, they’re invisible. And, until recently, they were mostly invisible when it came to regulation, too.

In a vacuum, some states stepped up to address PFAS contamination, particularly in drinking water, and others are just now tackling the issue. New Hampshire and Massachusetts are among the leaders. But the federal government has largely taken a hands-off approach, issuing guidance for drinking water standards but no legal limit, as it does for 90 other chemical and bacterial contaminants from mercury to the tetrachloroethylene that swirls in the runoff from factories and dry cleaners.

A bill that cleared the U.S. House of Representatives in late July, supported by the Democratic majority and nearly two-dozen Republicans, would require the Environmental Protection Agency to issue national standards for PFAS contamination. This is the second time the House has passed the bill. The Senate should see to it that it isn’t left to die on the vine again.

Michigan Rep. Debbie Dingell filed the legislation both times. According to the Detroit Free Press, she noted in a press conference after the bill passed the House most recently, on July 21, with a vote of 241-182, that the Pentagon has known about the dangers of PFAS to humans since the 1970s. Here we are, some 50 years later, with an advisory limit from the EPA for drinking water — 70 parts per trillion — but no regulation.

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~sThe Eagle Tribune, 4 August 2021

~rEUROPE

REgulatory Focus, 26 July 2021
; https://www.raps.org/news-and-articles/news-articles/2021/7/fda-seeks-comments-on-regulation-of-kratom-6-other
; https://www.eagletribune.com/opinion/our-view-feds-should-limit-forever-chemicals/article_76dd2a4f-259a-56da-9f16-d3ee2f3d942d.html