Federal regulators stumble with vaping, social media, talc, and kids car seats

fdanulogo-300x126As snarky youngsters might say, “Well, OK, Boomer:” Federal watchdogs keep looking more than a little pitiful as they find they not only have fallen behind the times but keep racing to chase trends and technologies that have zoomed beyond their control.

In the meantime, consumers suffer the consequences.

Recent news reports show, for example, how vaping youths already may have found a big work-around with federal crackdowns on e-cigarettes and how social media has become a viper’s nest of not only quackery but a dubious diamond mine for Big Pharma exploitation.

Add in the rising information about regulators’ struggles to safeguard the public with too familiar products — from car seats that are supposed to protect our kids to risky personal hygiene powders — and it may be beyond high time to ask if political balances need resetting between the interests of big businesses and ordinary consumers?

The big loophole in e-cigarette flavor ban

disposableecigpuffs-300x231So much has been reported on the rise of e-cigarettes and vaping that it may seem to be unhelpful piling on to note the latest regulatory gap in a widely promoted crackdown on an unhealthy practice that may have hooked a generation of young people on nicotine and even tobacco-burning cigarettes.

Still, palm meet face. What parent, educator, or public health expert isn’t slapping their foreheads and asking, What was the federal Food and Drug Administration thinking when it inserted a footnote in its new ban on most e-cigarette flavors, especially the sweet and candy-like tastes that have made vaping a teen phenomenon?

As the New York Times reported, in an apparent move to mollify vendors of vaping goods and e-cigarette makers, the FDA exempted disposable products from its flavor ban.

This has meant that kids now are flocking to get their hands on products that are cheaper and may be more accessible to more of them than they had with flashy and expensive products like the super popular Juul unit (a starter pack for which runs a pricey $50 or so).

Instead, retailers have been candid in saying they’re seeing a spike in sales for Puff Bars, blu, Posh and Stig, disposable vaping units that cost $9-$10 each and are advertised as satisfying most users’ needs for a day or so. They not only come in bright colors and different flavors that users like, they also don’t require messy refills. And if grownups get exercised about kids using them, teens, of course, can just toss one away.

The disposables may deliver higher doses of nicotine than a Juul unit, which is saying a lot because the costly devices could serve up as much of the highly addictive and damaging chemical as a pack of cigarettes. By the way, there’s also an argument to be made that by pushing teens toward disposables and getting them hooked on nicotine and comfortable with a lower price point, hasn’t that boosted the allure of a pack of old-fashioned, killer cigarettes, costing a little more than $5 in Virginia or $8 in the District of Columbia?

Cigarette smoking, the federal Centers for Disease Control and Prevention reports, “causes about one of every five deaths in the United States each year. Cigarette smoking is estimated to cause more than 480,000 deaths annually (including deaths from secondhand smoke). Smoking causes cancer, heart disease, stroke, lung diseases, diabetes, and chronic obstructive pulmonary disease (COPD), which includes emphysema and chronic bronchitis. Smoking also increases risk for tuberculosis, certain eye diseases, and problems of the immune system, including rheumatoid arthritis. Smoking is a known cause of erectile dysfunction in males.”

Besides regulators demonstrated inability to keep up with e-cigarettes as a new, potent, tech-based delivery system for nicotine and tetrahydrocannabinol or THC, the substance that gives marijuana its high, media reports have highlighted how vaping interests exploited social media and other online resource to target and sway young audiences, too often with the ignorance and lack of federal oversight and curbs.

Studying the barn door as the house burns

kimk-150x150When an item on this blog somehow mentions Big Pharma, the FDA, and a pop figure like Kim Kardashian, something serious has gone awry.

As the readable Fashion Law blog explains this sketchy convergence and serious folks’ interest in it, citing in part Stat, the science and medical news site:

“[W]hen Kim Kardashian posted about morning sickness medication Diclegis on her Instagram in 2015 (in exchange for a reported $500,000 payment), drug-maker Duchesnay was able to rack up nearly half a million likes and boost the social media conversation about its drug by 500% by way of Kardashian’s endorsement. More than that, Stat says that sales for the prescription medication jumped 21% to nearly $41.7 million.”

That foray into a world unseen by many adults — the land of “influencers” on a site heavy with endless photos of people doing all manner of activities — not only occurred three years ago. It triggered an FDA warning to the drug maker, and, only now, it finally has prompted the powerful watchdog to dig deeper into exploitation of social media, especially imagery sites, by major businesses like Big Pharma.

As lawyer Julie Zerbo reported on her fashion-focused site:

“As part of a formal study, the FDA [announced] it is planning to examine the promotion of medications by celebrities, physicians, patients and online influencers to determine the extent to which paid endorsements affect consumers, including their ‘attention to disclosure statements and risk/benefit information; retention of risk/benefit information; recognition of [the nature of the content as a] promotion and endorser as [having been] paid; perceived benefits and risks, attitudes toward the product, endorser, and ad; and behavioral intentions, such as asking a doctor about the drug.’ One aspect of the agency’s two-part study, which is slated to commence this fall, according to a spokesman for the FDA, will compare consumer responses to pharma-related posts from different types of endorsers. This will be tested by showing survey participants ‘an Instagram post for a fictitious endometriosis product,’ and manipulating an array of factors, including ‘the explicitness of the payment disclosure,” and the endorsers, themselves, including “celebrities, physicians, patients and online influencers.’”

Well, OK. But, as a separate and timely report in the ABA Journal magazine finds:

“From diet shake powders to vitamin supplements, social media is filled with posts and targeted ads for health products and services. While some products, such as vitamin supplements, are benignly ineffective, others make outrageous claims that attract desperate consumers hoping to cure cancer, HIV and other diseases. Social media offers cheap and targeted advertising that regulators don’t have the time or resources to fully monitor. Deceptive health claims that would land a company in court if made on television or radio are slipping by online. State and federal regulators as well as watchdog groups say the problem is only growing, allowing many to escape legal accountability for selling or promoting products that don’t live up to their promises.”

The excellent article by Emilie Le Beau Lucchesi, a Ph.D., author, and scholar of health communication, medical history, and “stigma communication” traces the history of “snake oil” advertising and the explosion of sketchy and dangerous claims of many different kinds online, especially via social media. Lucchesi reports that the FDA and the Federal Trade Commission are woefully understaffed and quotes regulators as, basically, shrugging at unacceptable online and social media behavior.

The new technologies allow scammers to target the gullible with such accuracy and ease that it can take too much time for problems to grow so bad as to attract possible regulatory action, Lucchesi reported. Even then, the con may have harmed relatively few people, such that it may not be worth the time and resources for official watchdogs to pursue action, leaving advocacy and consumer organizations to play whatever out-sized roles they can.

Even as public health officials struggle with an “infodemic” of damage caused by mis- and disinformation about the global coronoavirus outbreak on social media, public anger has been directed at a group opposed to vaccinations and operating on Facebook. A mother joined in a conversation on the social media channel, soliciting advice about her ill child. Group members told her she should not follow her doctor’s orders, including giving her sick child the antiviral medication Tamiflu.

The woman’s child died four days later, after she posted online that she had given the youngster nostrums recommended by group members, NBC News reported:

“The mother also wrote that the ‘natural cures’ she was treating all four of her children with — including peppermint oil, Vitamin C and lavender — were not working and asked the group for more advice. The advice that came in the comments included breastmilk, thyme and elderberry, none of which are medically recommended treatments for the flu.”

Why does anyone take medical advice from strangers online or give credence to celebrity endorsements or information from sketchy vendors? There may be loads of work for rigorous researchers, such as those at the RAND Corporation diving into what they term Truth Decay.

Old-school problems for today’s fumbling regulators

carseatinvestigationpp-300x141Even as the nation’s watchdogs stumble along in coping with rapidly advancing technologies, their record is more imperfect and apparent with persistent oversight problems of more traditional types.

A New Jersey jury, for example, just underscored with a big verdict why the FDA maybe should take heavy public fire for failing to ask whether commonplace baby powders long have been tainted with cancer-causing asbestos.

Jurors heard a civil case involving such assertions and awarded claimants $750 million in punitive damages and $37.2 million in compensation for cancers that victims claimed were caused by long use of Johnson and Johnson talc. The judge slashed the jury’s punitive award to $186.5 million, saying that state law caps verdicts in cases like this one to five times the compensatory damages.

This case was unusual because J&J’s CEO testified in it. It is now one of a string of losses suffered by a corporation that built its brand as a “family friendly” business.

The New Jersey decision was handed down within days of the FDA conducting its first hearing in decades on talc and its possible taint with asbestos. The initial session focused on technical issues, notably the best practices for testing, and much more work will need to occur before the agency figures its next steps in a health concern made a public cause by the civil justice system.

Other federal regulators, notably those at the National Highway Traffic Safety Administration, find themselves on the griddle for oversight problems involving a too familiar product: the child safety seat. ProPublica, a Pulitzer Prize-winning investigative site, has raised serious safety issues with one of the biggest selling booster seats for youngsters weighing less than 40 pounds.

Despite claims to the contrary by the product maker Evenflo, the Big Kid booster, ProPublica found, puts kids at high risk in “side-impact crashes, which were responsible for more than a quarter of deaths of children under 15 killed in vehicle collisions in 2018. While less common than head-on crashes, side impacts are more likely to result in serious injuries in part because there’s only a door separating the passenger from the intruding vehicle.”

Company tests show the product’s vulnerabilities and firm officials have, for fierce competitive reasons, battled regulators efforts to require the boosters, like other child-restraining seats, to be harnessed in with belts already in the vehicle. ProPublica has reported that weaknesses in the way that NHTSA works effectively allow companies like Evenflo to self-regulate, creating nightmares as have happened with children harmed and killed in booster seats.

In my practice, I see not only the harms that patients suffer while seeking medical services, but also the damage that can be inflicted on them and their loved ones by defective and dangerous products, especially when they are promoted in deceptive, misleading, and inaccurate ways. Sadly, to paraphrase a former president, we live in an era where we may need to go far beyond skepticism and adopt a view of Don’t Trust and Verify.

All of us can learn more about the workings of medical and science reporting, particularly of research studies. But we more than ever need to engage our brains and critical faculties, testing online and social media materials — sadly, maybe official pronouncements from our government — with what author Ernest Hemmingway described as, um, a nonsense detector (his language was rougher).

We also need to push politicians — hard — to hold accountable and support public watchdogs, so they don’t put the interests of wealth corporations ahead of ours.

Patrick Malone & Associates, P.C. listed in Best Lawyers Rated by Super Lawyers Patrick A. Malone
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