Nearly all of the herbal dietary supplements tested in a Congressional investigation contained trace amounts of lead and other contaminants, and some supplement sellers made illegal claims that their products can cure cancer and other diseases, investigators found.
So begins an article in the New York Times on a Government Accounting Office report released May 26 that questions the safety of supplements. Could plaintiff attorneys be thumbing through the pages looking for defendants?
Very little in the report is news to the industry. A number of supplements have trace amounts of ingredients that could be harmful in large doses. And questionable health claims are commonplace.
A government study carries weight in the mind of jurors considering product defect claims: Did a supplement make plaintiff sick? Did it contribute to health problems? Did the manufacturer take adequate steps to ensure the safety and quality of its product? This is the stuff of litigation.
The report has led to the usual suggestions: better disclosure of ingredients on labels; better inspections of manufacturing plants; better enforcement of rules on product claims; and FDA power for recalls. None could prevent tainted products from being marketed and sold, so what legislation cannot do, litigation might.
About Joel Rothman
Joel B. Rothman represents clients in intellectual property infringement litigation involving patents, trademarks, copyrights, trade secrets, defamation, trade libel, unfair competition, unfair and deceptive trade practices, and commercial matters. Joel’s litigation practice also includes significant focus on electronic discovery issues such as e-discovery management and motion practice relating to e-discovery.
I have worked in the natural health products business as a science director and product designer. There are many well-identified manufacturing practices that are despicable yet routine. “Fairy Dusting”, “Spiking” and undeclared excipients come to mind. Regulatory authorities everywhere refuse to address this. On the other hand natural health products are ridiculously safe. Whatever standard is used to evaluate NHPs, let that – mutatis mutandis – be applied to pharmaceutical drugs and we’d have an end to them! The problem is there remains a great deal of hostility between the medical, scientific and regulatory establishment and the insurgents. The insurgents own the power of the public, are well entrenched in academia, and most of the political powers. Also, the media. And, there is a lot of money and business power in natural health. There can’t be any thoughts of wiping it out. Those days are gone. The rising costs and declining outcomes of regular medicine make the growth of natural medicine a certainty. If regular medicine was so good why does natural medicine thrive? Right through the recession, by the way. And mostly paid for by the end user out-of-pocket. Banning NHPs that people freely want for their own health – criminalizing it – will provoke a mighty public ‘health freedom’ outcry which will descend as it has before on the heads of members of parliament. Since they are sympathetic Health Canada loses all these contests. So does the FDA. So, why can’t we have honest and well-made natural health products? There has to be an independent authority to conduct testing because no one will trust anything that the regulatory authorities are involved in. At the end of the day are health cops going to arrest grandmothers for periwinkle extract? Bad optics.
The other day I was making some split pea soup and re-noticed the disclaimer that I’ve seen for years where the packaging warned something to the effect of “natural products such as this may contain small stones”. Small stones?! Really?! I could break a tooth…it might have germs and I could get sick…it might get stuck in my intestines and cause me to collapse in the middle of the street causing me to get hit by a bus.
I also have recently re-read that my liver could fail and I could die if I somehow mis-dose with acetaminophen.
I decided not to call my plaintiff attorney and I went on making the soup with the idea that if I saw any small stones I’d tossed them and if bit one I’d spit it out. The soup was excellent.
And instead of killing my liver, I chose a safe, natural pain reliever and was just fine. The fact is that consumers aren’t complete dolts. We understand risks and make decisions based on them.
YES the split pea makers should try and remove all stones (and they do) and YES acetaminophen is toxic and can be fatal and yet is “approved” by the FDA (i.e. more hazardous than NHP!!) and YES natural health products, as with anything made by humans, has the possibility of contamination BUT, for the same reasons the split pea makers comb through their product (they don’t want dental lawsuits or bad PR, they just want to sell something the public wants to buy), natural products are generally kept VERY SAFE.
YES there are NHP’s that make inappropriate claims and should be held accountable for accuracy and ethics, and there are those who do not understand or take Quality Control / Quality Assurance seriously, BUT many NHP stay within guidelines and provide safe, efficacious products.
We do not need more regulations…we simply need the CGMP (current Good Manufacturing Practices) to be employed / enforced. These guidelines are known to the industry and will protect the consumer “enough” so that they are able to make informed decisions with an acceptable level of confidence.
Mark Faulkner
ProMera Health
(StayActiv natural pain relief)
Nutraceutical product, this name stems from combining the word “nutrition” and “pharmaceutical,” One could say that it is the developed or modernized way of ancient Egyptian, Chinese and Sumerian’s way of curing diseases by using food. Then only herbs and spices were used for medicinal use but in modern days many additional products like fruits and vegetables and even the leaves are being used.