The Dietary Supplement Health and Education Act of 1994 (DSHEA) allows herbal and non-herbal supplements to be sold in the US without demonstration of effectiveness or safety. Despite recent improvements in Good Manufacturing Practices required of supplement manufacturers, these products still pose significant risks to the population simply because the hands of regulatory authorities are tied – products cannot be removed from the market until there is evidence for lack of safety, meaning that consumers must first be harmed before FDA is authorized to intervene.
After cautions a couple weeks ago from FDA, we learned today why a popular liquid dietary supplement has been causing adverse reactions – selenium poisoning:
The FDA notified healthcare professionals and patients that it has found hazardous levels of selenium in samples of certain flavors of the dietary supplement products “Total Body Formula” and “Total Body Mega Formula.” Analyses of samples by FDA have found most of the samples contain extremely high levels of selenium — up to 200 times the amount of selenium indicated on the labels of the products. The FDA has received 43 reports of persons from nine states who experienced serious adverse reactions using these products. The adverse reactions generally occurred after five to 10 days of daily ingestion of the product, and included significant hair loss, muscle cramps, diarrhea, joint pain, deformed fingernails, and fatigue. Consumers should stop taking the products and consult their healthcare professional if they experience any adverse events associated with the use of the products.
Analyses of samples of the products by FDA laboratories have now found most of the samples contain extremely high levels of selenium–up to 40,800 micrograms per recommended serving, or more than 200 times the amount of selenium per serving (i.e., 200 micrograms) indicated on the labels of the products.
The LD50 for selenium in rodents and rabbits is on the order of 2 to 2.5 mg/kg body weight, meaning that the average 70 kg adult could take a potentially lethal dose of selenium with only four servings of this product. We’re not talking here about the hysterical rantings about “toxins” that would have deleterious effects if one drank a hundred cans of soda. Enthusiastic supplement users commonly use a few times more than the recommended amounts of “health products” – this product could have killed people.
Selenium is a relatively safe nutrient and most dietary supplement manufacturers have reasonable quality controls in place to be in the ballpark of labeled content. But one really has to screw up royally to release a product with 200 times the intended amount of any constituent. I can’t even think of how a mistake of this magnitude might have occurred – mixing up milligrams and micrograms would’ve caused a 1000-fold error, a mistake that would have certainly resulted in deaths.
What would be the harm in requiring supplement companies to confirm even the content of their products before they leave the factory. You don’t need weeks of optimizing an HPLC-MS method to measure selenium. Contract labs can do the measurements quickly for a couple hundred bucks.
But as long as DSHEA is on the books, supplement manufacturers have such wide latitude relative to any other facet of the food, drug, and cosmetics industries that a product like this can get out the door.
Even if our legislative leaders fail to find it important to require that supplements are proven effective for any health condition, we at least deserve to know that the products aren’t deadly.
However, the Coalition to Preserve DSHEA argues instead that:
Congress may soon consider new legislation that would trump DSHEA and put consumer access to dietary supplements at risk.
The Coalition is described as, “a non-profit coalition comprised of major suppliers of dietary supplement products and services, as well as leading industry trade associations and other supporters.” This organization is also behind the website, SaveOurSupplements.org, to “protect your access to safe, effective, & affordable dietary supplements.”
Safe? Effective? Neither of these attributes are required by current legislation. So please don’t insult us by implying this is the case.
Affordable? Now I see. Preventing any requirements for prospective demonstration of safety or confirmation of supplement content would certain cut into profit margins.
For anyone who ever thought that dietary supplements are made by altruistic hippies frolicking in nature, think again – it is just another business trying to get by with minimal regulatory oversight.