Marketers of "wellness products" receive FDA warning letter over unauthorized health claims
Considering what’s posted on the company’s online profile page, you’d think HealthWorksUSA President Dale Jansen would have known better than to market his “wellness products” with unauthorized health claims.
“You won’t hear about stabilized aloe in the news or from your doctor because the FDA won’t allow natural products to make health claims,” reads a section of the company profile page with Jansen’s name and title at the bottom.
Yet, that’s exactly what Jansen did, according to a recent warning letter from the FDA to the HealthWorksUSA president. The letter cites therapeutic claims that classify some of Jansen’s products containing stabilized aloe as drugs, a classification that is illegal without FDA approval.
The challenged claims include one on the cover of the corporate health manual HealthWorksUSA sells to companies (see right) that states, “Heal Yourself of Any Disease.” The unapproved claims also appear on product pages, including one for NutraGel that states, “NutraGel allows you to enjoy the sun longer without damaging your skin.”
The letter states that the claims are made online at www.healthworksusa.net but that site bounces to www.healthworksusa.com. Most of them remained on the site as of this writing.
The recipient of an FDA warning letter generally has 15 days to correct the violations. The HealthWorksUSA missive was shipped out Nov. 24.
Here is some preparatory reading for the latest gender rights fight in Peggy Young Vs. UPS that has reached the US Supreme Court
The U.S. Supreme Court held oral arguments in yet another blockbuster case at the intersection of sex discrimination, workplace law and reproductive justice. The central issue in Peggy Young v. United Parcel Service is simple enough: to what extent does the federal Pregnancy Discrimination Act of 1978 require employers to accommodate the health needs of pregnant women? But the potential repercussions of the gender rights case could be both complex and wide-ranging.
Young, a one-time delivery truck driver for UPS, asked in 2006 only that, since she was pregnant, she be excused from lifting anything over 20 pounds, per her doctor's orders.
But Young's job description required her to sometimes lug up to 70 pounds, and UPS argued that assigning her to "light" duty would amount to special — i.e., unfairly favorable —treatment. The company said its policy was only to accommodate people temporarily injured on the job and in a few other gender-neutral circumstances mandated by its union contract and the American with Disabilities Act. Young was forced to take seven months of unpaid leave, losing her medical benefits in the process.
The resulting discrimination suit is being watched especially closely because of last summer's momentous ruling in the Hobby Lobby contraception case, in which Justice Ruth Bader Ginsburg accused the court's conservative majority of having a "blind spot" on women's rights. (Among other things, the same five justices have thrown out a massive sex discrimination class action against Wal-Mart and rejected Lilly Ledbetter's equal pay lawsuit.)
Women's advocates are dismayed by the potential real-world impact that a ruling against Young might have for tens of millions of American women and their families, especially those on the economic margins. A recent study by the National Partnership for Women & Families found that many pregnant women are denied even the simplest accommodations, such as extra bathroom breaks; since the Pregnancy Discrimination Act became law, the percentage of expectant and new mothers who report being fired or laid off from their jobs has actually grown, notes a new report by the San Francisco–based public interest law firm Equal Rights Advocates.
"Pregnancy discrimination doesn't just harm women while they're pregnant — it has ripple effects throughout their careers," said Emily Martin, vice president and general counsel for the Washington D.C.–based National Women's Law Center, which published its own report on the issue last year. "Losing a job when you're pregnant, having to find a new job when you've just had a baby ... can make the birth of a child be an entrance into poverty."
UPS, for its part, argues that its actions violated no laws, and that it afforded equal treatment to all its personnel, pregnant or not. Under the Pregnancy Disability Act, employers are required to treat expectant and new mothers the same as employees who are "similar in their ability or inability to work" — not to treat them better, the company says. UPS insists it was bound by its Teamsters contract, which permitted alternative work assignments under certain circumstances — for example, suspension or revocation of a driver's license — but not in Young's case. Nor was Young's condition covered by the American with Disabilities Act, UPS adds.
Pregnancy-related discrimination isn't just a workplace issue. Claims have also surfaced in mortgage lending, housing and education. Discrimination colors the way the criminal justice and child welfare systems treat pregnant women who use drugs or do anything else that authorities deem potentially harmful to an unborn child, women's groups say.
"The ideas that because of pregnancy, women can't do certain things, or shouldn't do certain things, or we can't accommodate them doing certain things — they stem from the same place, the same stereotypes about gender roles," said Sara Ainsworth, legal director of the nonprofit National Advocates for Pregnant Women.
For more about the Young case and the issues it raises, here's a short reading list.
"Pregnancy Complication: Many employers do not want to accommodate their pregnant workers. Will the Supreme Court make them?" at Slate is a quick yet thorough overview of the Young case by New York lawyer Gillian Thomas, author of a forthcoming book profiling 10 of the Supreme Court's most significant decisions affecting working women.
"Former UPS driver at center of pregnancy discrimination case before Supreme Court," by The Washington Post's Brigid Shulte, is an engaging profile of Peggy Young, reluctant feminist symbol.
"This Supreme Court Case Will Decide Whether Companies Can Treat Pregnant Women Like Crap," in Mother Jones, focuses on an idea that has taken hold in many federal appeals courts — that treating women equally to other employees doesn't necessarily mean treating them well.
"How Family Leave Laws Left Out Low-Income Workers," published in the Berkeley Journal of Employment & Labor Law (2007), traces the history of various family-friendly federal laws, arguing that by espousing the notion of "strict equality" many well-meaning organizations have inadvertently left low-wage women (and men) in the lurch. The author, Ann O'Leary, is director of the Children and Families Program at the San Francisco-based nonprofit Next Generation and a one-time legislative director to then-U.S. Senator Hillary Clinton.
The EEOC's Enforcement Guidance on Pregnancy Discrimination and Related Issues, issued this past summer, probably comes too late to have much impact on the Supreme Court. But the guidelines are fascinating for the sweeping way they define pregnancy-related discrimination — ideas that many employers will find unpalatable, to say the least.
Arguments in the Young case also make for interesting reading. In its most recent brief in October, UPS doesn't just contend that its treatment of Peggy Young was perfectly constitutional — it also announces that it is voluntarily changing its policy and will now allow light duty for pregnant workers. (More on that reversal here.) In an amicus brief, 23 pro-life organizations weigh in on the same side as liberal groups, arguing protecting pregnant women from discrimination reduces pressure on economically vulnerable women to have abortions.
Representing businesses, the U.S. Chamber of Commerce argues that UPS's narrow reading of the Pregnancy Discrimination Act is correct and warns that a ruling for Young "would stretch core discrimination-law principles far beyond previously settled bounds." Yet another amicus brief, by the ultra-conservative Eagle Forum, suggests that pregnant women should not be working at all: "[N]either this court nor this nation have ever recognized a 'fundamental right to bear children while also participating fully and equally in the workplace.' ... Life is a series of tradeoffs and 'you can have it all' does not mean 'having it all given to you.'"
On a more practical level, Babygate, recently launched by the New York–based non-profit A Better Balance, is an exhaustive — and extremely useful — source of information and advice about the rights of pregnant workers and their families under state and federal law.
Even the Court has expressed concern about doctors performing too many tests on patients
This time, we put doctors, instead of lawyers, under the lens. And we have the tacit backing of the court.
As this is being typed, the author is recovering from a serious illness. It requires trips to the hospital and a series of tests; rather costly, but necessary to be put on the road to recovery. Friends phone or visit. Most have some advice or the other. They want to know the reason why many other tests ‘were not taken’.
A couple of days ago, the court remarked on how medical treatment is getting out of hand—with one test after the other. There is also talk about kickbacks from diagnostic centres encouraging doctors to recommend unnecessary tests. And, if you seek a second opinion, you will have to do the same tests all over again. True, very true. But the flip side needs be considered. Audi alteram partem.
Part of the reason for mounting expenses is the rise in instances of medical malpractice litigation. While, no doubt, people are being killed left, right and centre, and doctors are attacked at the drop of a hat, the issues are deeper. We will analyse them and then…
You be the judge
A day after the court’s observation came news of forced sterilisation that snuffed out many lives. There can be no excuse for that. Malpractice is a mild term for this type of manslaughter. Were preliminary tests taken? Doubtful; especially when the process was almost on an assembly-line basis. Some reports suggest the quality of antibiotics and pain-killers is under investigation.
Should not tests have been taken? In hindsight, most patients would have wanted them. But, at that particular moment, the women would have baulked. There would always be the burden of extra charges. The women had come for free tubectomy.
The problem with tests is this. Until a positive result is obtained, that is, until a disease, or some problem, is identified, tests have to continue. The doctor wants to be sure. He is fully aware of the Damocles’ sword hanging over him. He does not want to take risks. In other words, he does not want to be sued. Even though he has acted in good faith, he can be dragged over the coals and with a sensationalism-obsessed media barking at his heels, he wants to be doubly sure. Ergo, tests.
The past few weeks have been educative. The author is out of action and so is his lawyer.
A doctor’s son, the advocate, had to undergo many tests before he was on recovery street.
His assistant, a young newly-minted advocate, was down with dengue. Tests had to be performed to determine if it was not a run-of-the-mill fever. Without the tests, the boy and his doctor would have been in deep trouble.
You be the judge.
The court had bemoaned the lack of the family physician’s touch. Reminiscing about the time when the corner doctor seemed to cure all with a few coloured and foul-tasting ‘mixtures’, one wonders what happened to that world.
There were no malpractice suits, in those days. Docs did not get hammered by relatives venting their frustrations, often misplaced, on them. Hospitals were not overburdened.
The cities were cleaner and epidemics not rampant. Quinine and penicillin were enough to eliminate the most persistent bugs. Rifampicin v/s TB was in favour of the former.
Drug resistance was unheard of. Today, it is different.
So, should tests be taken or not? Yes and no, would be the best answer that we can come up with. Yet, a modicum of measured approach by doctors may well be needed. In the case of this sick author, only those tests that were deemed absolutely necessary were carried out. It was a step-by-step approach. In spite of the many tests that the friends recommended, the faith in the doctor was justified.
It’s a dicey situation.
You be the judge. When and how does one cross the thin red line?
(Bapoo Malcolm is a practising lawyer in Mumbai. Please email your comments to [email protected])