Let the Buyer Beware

November 24, 2015 in General, Nutritionism, Uncategorized by Joyce Bunderson

Let the buyer beware (Caveat Emptor) is an old (1523) but useful adage, especially when making the decision to buy and take supplements. Those of you, readers of this blog over the long haul, are probably not surprised to have another warning about supplements. You are already aware of my suggestions to take careful consideration before taking supplements, or my blunt advice not take certain supplements. There was a government crackdown on supplements last week that quickly caught my attention.

Just in case the news slipped by you on Tuesday, November 17, 2015, the Department of Justice (DOJ) arrested six executives of a Dallas, Texas supplement maker, USP Labs. The Texas arrests are part of a larger crackdown on some of the more unscrupulous players in the $35 billion supplement industry. The DOJ made a statement saying; “The sweep resulted in civil injunctions and criminal actions against 117 various manufacturers and/or distributors of dietary supplements and tainted products falsely marketed as dietary supplements.”

Because dietary supplements fall outside the Food and Drug Administration’s (FDA) oversight and regulatory controls, it’s more common and much easier for deceptive practices to arise. The critical difference with the FDA’s regulation of pharmaceuticals vs. supplements is that the supplements do not need FDA approval before being stocked for sale. It’s very rare that a firm needs to provide the FDA with evidence showing that the supplement ingredients are safe or actually work. In addition, with supplements, the FDA actually has to show that a dietary supplement is unsafe before it can pull it from store shelves; unlike pharmaceuticals, which must prove in clinical trials that the product is safe and does what it says before they can put it in pharmacies.

In this latest crackdown, some supplements were labeled as “natural” when in fact, some of these actually included prescription drugs and/or synthetic ingredients. Others were caught making unsupported claims about effects of the products; claiming curative properties for diseases ranging from cancer to herpes.

The majority of the most recent fraud cases involved a product label claiming that the product was derived from natural plant extracts. Two of USP Labs products are Jack3d and OxyElite. Prof. Benjamin Mizer, the head of the DOJ’s Civil Division said that the executives claimed their product were made from natural plant extracts; the truth is that the stuff is completely, 100% synthetic stimulant made in China. Now here’s the really sad part of this story. The company claimed on product labels that DMAA (1,3 dimethylamylamine) was a geranium extract. Two soldiers died after taking DMAA, which can cause heart attacks.

Another of their products OxyPro New Formula, caused an outbreak of liver injuries. Several people experienced jaundice (the liver is struggling to clear bilirubin), jaundice is not harmless; it can cause brain damage and even death. Some of the OxyPro new Formula users were not as fortunate; they needed liver transplants to save their lives. The excessively distressing part of this story is that USP labs was told to take their intentionally misbranded product off the market (labeled natural plant extracts, instead of synthetic stimulants); but instead, they launched an all out effort to get the product out of their warehouses to the distributors as quickly as possible. They knew it was causing problems! This is not a tiny company; they have sold 400 million dollars between 2008 and 2013. It’s taken all this time (lost lives and damaged health) for the DOJ to do something about it.

Dr. Pieter Cohen of the Harvard Medical School, who studies supplement safety, said: “We need a system that prevents these dangerous supplements from arriving on store shelves in the first place.”

A study published on October 15, 2015 in the New England Journal of Medicine reported that 23,000 people in the U.S. end up each year in emergency rooms because of adverse events caused by dietary supplements.

A really interesting twist of last Tuesday’s story is that a lobby group for supplement makers, The Council for Responsible Nutrition, actually went to the DOJ noting their concerns that “companies engaging in blatant criminal activity were presenting a serious public health risk and hijacking the credibility of the reputable industry.”

Let’s not forget that supplements are not just causing heart attacks, strokes, liver disease and cancer. People who believe that they can take a handful of supplements to make up for unhealthy eating are risking their nutrient balance too. Certainly, I’ve written about this frequently, but it needs addressing again and again. Remember there’s a plethora of evidence that points us away from relying on supplements. If you’re new to this blog, I will recommend reading an old blog of mine from 2010 - Nutritionism: Using a Single Player instead of the Entire Team; I believe that I did a fair job of trying to help our readers understand that whole foods provide a very large ‘team’ of nutrients, not obtained by taking supplements.

Only after people are harmed does the government step in – the government is playing catch up. In one example, March of this year, the British Journal of Cancer published a study that found a link between those taking muscle-building supplements and increased risk of testicular germ cell cancer (TGCC). It’s essentially all the government can do until the laws are changed. So will you take your chances and risk a serious and adverse health reaction? Don’t think you are safe. In this situation you must be the one looking out for your health and that of your children and family. I continue to say, “Be careful.”

Even if we do get more government regulations for supplements, we must embrace the old adage, Let the Buyer Beware. We can’t have a sense of contentment that the government is able to keep us safe with the present laws for dietary supplements, and even if they improve in the future, the responsibility is still in our hands.