Regulatory agencies (e.g., FDA, OSHA, CPSC, NHTSA, etc.) exist to serve and protect the public from bad actors in the corporate or industrial world whose decisions and actions may lead to products or services that could potentially harm or kill workers and consumers. It would seem obvious, therefore, that the leaders of these agencies would be strong, neutral and objective regulators without close ties to the very industries they must regulate. Under such a model, the best interests of the public could be served without concern for the profits of the regulated industries. Unfortunately, as anyone who reads any newspaper knows too well, that model has never been true. In fact, since the creation of virtually every regulatory agency, the leadership of these agencies have either come from or exited to the very industries they were to regulate.
Last month's issue of the Goldhaber Warnings Report focused on the dangers of added sugar to many products sold in the U.S. But sugar, while a major culprit in the causal chain leading to a variety of serious illnesses such as Type 2 Diabetes and other cardio-vascular diseases and certain cancers, is not the only food product that may need a safety warning. Let's look at a few potential examples of products that might benefit from a safety warning.
If you buy a box of Kraft Mac & Cheese in the UK (the same Mac & Cheese that is sold in the U.S.), the following warning label appears on the package: Warning: This Product May Cause Adverse Effects Activity AndAttention in Children. This warning is required because the U.S. version of Kraft Mac & Cheese has artificial food dyes yellow #5 and yellow #6, which are proven to be linked to hyperactivity in children. The warning does NOT appear in the U.S.
Ten years ago, Federal Judge Robert Sweet ruled in the Pe1man v. McDonald's Corp. case that the plaintiffs' complaint failed to prove that McDonald's was responsible for the two teenagers' obesity. Attorney David Wallace wrote in a recent issue of Product Liability Law and Strategy that given the statistics (1/3 of U.S. adults and 17% of U.S. children are obese), "the number of potential claimants is staggering." While the original claims in the Pe1man lawsuit may be difficult to prove on causation, specifically linking the consumption of higb-fat, high-salt fast foods directly to the effects of obesity, such as Type 2 diabetes and other cardiovascular risks, a different claim may be more successful.
In the November, 2012 issue of this newsletter, I wrote that the FDA was investigating reports of deaths due to the intake of energy drinks and was determining if energy drinks were safe. Earlier this month, the FDA issued a harsh warning against energy drinks and supplements containing the stimulant dimethylamylamine (DMAA), telling consumers to stay away from it while adding that the agency was "using all available tools at its disposal" to ensure that it is no longer sold. This is a formidable task because we as a nation spend more than $12.5 billion a year on energy drinks, shots and drink mixes. Although seven other countries, including Canada, had previously banned supplements containing DMAA, these products had remained widely available at supplement stores in the United States, including GNC.
This week, as my family and I prepare for a one week Caribbean cruise, the last thing on our minds is what legal recourse we may have should something go awry on our vacation. However, with the recent crippling of the Carnival Triumph which, following an engine fire, was adrift for four days with overflowiug toilets, unbearable heat and never-ending lines for food, the first two lawsuits have been flied agaiust Carnival Cruises.
According to news reported almost daily, we are and will continue to experience flu activity in the United States at record levels. Both the CDC and the Mayors of major cities such as Boston and New York have declared public health emergencies blaming the current raging flu epidemic. We all know the symptoms of the flu: aches and pains throughout the body; blocked or runny nose; chills and cold sweats, fever, fatigue or sore throat. Most medical experts agree that the quickest and safest way to prevent the flu is to get a flu shot and let the vaccine now on the market stop the epidemic spread of the flu. Sadly, as of this date, slightly more than 1/3 of our citizens got vaccinated.
Earlier this month, the New York Times reported that the Food and Drug Administration (FDA) had received claims that the drink 5-Hour Energy may have led to 13 deaths and 33 hospitalizations in the last four years. 5-Hour Energy is a highly caffeinated energy shot sold by Michigan-based Living Essentials (a unit of Innovation Ventures) in 2-ounce packages equivalent to drinking about two cups of coffee.
As we approach the holiday season this year, we should keep in mind a new study released last month warns that 42% of Americans could be obese by 2030 (up from 36% in 2010) and 11% could be severely obese, which means about 100 pounds overweight (vs. 6% in 2010). The study, done by the Trust for America's Health and the Robert Wood Johnson Foundation projects that in every state the rate of obesity could reach 42% and in thirteen states, that number could exceed 60% of the population. Mississippi, which currently leads the nation in obesity rates, could have as many as 2/3 of its population obese by 2030.
Tara Godoy, the President of University Park Legal Nurse Consulting in the Northern San Francisco Bay Area recently brought to our attention via a posting on the Expert Witness Network that the FDA earlier this month has issued a consumer advisory warning the public that popular topical pain relieving products such as IcyHot and Bengay have been linked to a risk of a rare chemical burn injury.
Last month, two California mothers sued General Mills claiming that they falsely advertised and deceptively marketed its Nature Valley products as "natura1" when they contain highly processed ingredients such as high fructose com syrup, and high maltose corn syrup and maltodextrin, a thickener that also adds sweetness to food. The lawsuit was filed in the United States District Court for the Northern Division of California and charges General Mills with false advertising and anticompetitiveness under California law.
New York State Attorney General Eric Schneiderman filed 12 civil lawsuits on July 10,2012 throughout New York State against 16 head shops that sold synthetic drugs which were marketed as different products such as glass cleaner, potpourri, bath salts and spice. The main claim in these lawsuits is that the products violate consumer protection laws for labeling by failing to warn consumers of the products' content, safety and health risks.
Anyone who bas seen a football helmet in recent days may be swprised at the bluntness of the warnings advising players that the very product they are wearing to prevent injury may not do that at all. For example, the warning that appears inside helmets manufactured by both Schutt Sports and Rawlings contain Oris conclusion:
Mayor Michael Bloomberg of New York City this month has proposed a ban on restaurants, theatres and food carts regulated by the City selling soft drinks in excess of 16 ounces.
I just came back from my phannacy where I picked up two prescriptions for my seasonal allergies. One was a name brand product and another was a generic.
Last month, Judge Richard J. Leon of the United States District Court in Washington, D.C. permanently blocked the FDA reqillrement that was to go into effect later this year that would have forced the tobacco industry to put extremely graphic warnings on the top half of the front and back of a pack of cigarettes.
New York City has done it again! Mayor Bloomberg (or as some call him, NYC's Nanny-In-Chief) and his City Health Department has declared war on oversized restaurant portions.
My former business partner, Marshall McLuhan was fond of telling me that North Americans go out of their homes to be quiet (compared with Europeans who go out to be social).
The awards season is already in full gear this year. The Golden Globes have already been given out and the Oscars will be determined by the end of this month.
The Goldhaber Warnings Report:...Unlike its previous hearingswhich addressed the NFL’s lack of adequate protection against brain injuries, the Houston hearing focused on risks faced by younger football players. Several million high school and college students play football...
The Goldhaber Warnings Report: On January 2, of this year, The New York Times published an article about the possibility of heavy cellphone use being linked to brain cancer. Since approximately 280 million people use cellphones
The Goldhaber Warnings Report: This past weekend as Hurricane Bill brushed past the Eastern Coast Line of the United States, bringing dangerous riptides to our shores, police and lifeguards posted explicit warning signs (reinforced by nonstop media coverage about the dangers of these riptides) closing beaches from North Carolina throughout New Jersey, New York and New England. Despite this barrage of warning and safety information, who can forget the televised images of the hundreds of apparent daredevils, mostly young men, ignoring the warnings and entering the beaches to look at the waves, and even swim or surf in the turbulent waters!
The Goldhaber Warnings Report: In the last issue of this newsletter, I listed the major components found in most warnings along with making several suggestions that should help improve a warning’s conspicuousness and make it more likely to gain the attention of the product’s user at the time of use. The following is an example of a warning that
The Goldhaber Warnings Report: The U.S. Supreme Court ruling (March 5, Levine vs. Wyeth) will have major implications for the pharmaceutical industry forcing them literally to review all of their warnings and safety instructions for content, clarity and conspicuousness
The Goldhaber Warnings Report: In the last issue of this newsletter, I listed four key questions that must be answered when conducting a warnings review. Answers to these questions, as well as following the detailed steps I now provide, should help you determine whether or not you need to warn or, if you already warn, whether or not your warning(s) is/are adequate
Ian Allport, principal at Radical Software & Consulting Inc., has over 30 years of experience in the Financial Services and Information Technology industry.
Monty G. Myers, PE, is an active Software Industry Executive with 30+ years of experience, including the founding of Eureka Software Solutions, Inc. (“Eureka”) and acting as CEO of Eureka for 28 years.
