Today the New York Times reported that the New York state's attorney general's office investigated over-the-counter supplement lines sold at GNC, Walgreen's, Walmart, and Target, and found that nearly all of them were fraudulent.
Tests showed that products labeled as medicinal herbs did not actually contain ANY of the herb, but instead cheap fillers like powdered rice and house plants!
As part of its investigation, the attorney general’s office bought up 78 bottles of the leading brands of herbal supplements from a dozen Walmart, Target, Walgreens and GNC locations across New York State. Then the agency analyzed the products using a type of genetic fingerprinting known as DNA bar coding that the agency has used to root out labeling fraud in the seafood industry.
Unfortunately, the problem of fraud and tainted and/or outright contaminated products is not terribly uncommon in the supplement industry. In 2013, for example, an outbreak of hepatitis that affected at least 72 people in 16 states was traced to a tainted supplement. Three people required liver transplants, and one woman died.
Hospitals have been affected as well. In December 2014, an infant at a Connecticut hospital died when doctors gave the child a popular over-the-counter probiotic supplement that was later found to be contaminated with yeast. After the child’s death, the FDA issued a warning to the public that reiterated its limited control over supplements.
While the FDA's limited control over supplements is a good thing in that it prevents consumers from having to obtain a prescription to get high-potency vitamin C, for example, the downside is that all kinds of shlocky supplement manufacturers are selling fraudulent products to consumers because there is no accountability in the industry.
This is a wake-up call to be very scrutinizing in what supplements to buy and from whom. Here, then, is a very brief checklist of things to ask about and look for when buying supplements.
1. GMP Certification: GMP stands for Good Manufacturing Practices, and it is one of the most important standards of elite quality supplements. GMP represents the stamp of approval of 1 of 3 independent entities: Natural Products Association (NPA), Therapeutic Good Association (TGA), and the National Sanitation Foundation (NSF). These organizations are reliable third-party sources of gold standard analysis on the quality of supplement manufacturing. While many companies claim to be operating at or above the quality standards of GMP, the only way to know for sure is if the company has been audited at random by one or all of these organizations and have been passed and certified to be operating according to GMP standards. Similar to how a doctor must acquire a license in order to claim to be a health professional, elite quality supplement manufacturers must be willing to have their feet held to the fire by having their quality control standards analyzed and scrutinized by GMP organizations before they can honestly claim to be in the health business.
2. Assays and Bioactive Profiles: An assay is a laboratory analysis of finished products and their individual ingredients. Bioactive profiles analyze the DNA and chemical structure of plant extracts to determine if the actives are still present in the raw material and to what level. Most companies do not perform these delicate analyses because they are not required by the FDA and they are very expensive. But these tests are the only way to determine if a batch of raw material is fit for human consumption, both in the way of validating label claim of herbs and other active ingredients, but also in the way of screening for contamination with molds, fungus, heavy metals, pharmaceutical agents, or other foreign materials. Many companies that do perform assays do them randomly, perhaps one batch out of every 10 or 20 at best. However, responsible quality control demands that assays be performed on EVERY BATCH because purity is not guaranteed with every batch of raw material, as actives and contamination can change radically from batch to batch.
3. Human Evaluations on Finished Products for Determining Safety and Efficacy: Research on finished products is almost never done in the supplement industry. I know of only one company performing human trials on finished products in a real clinical setting. Seriously. One company. It's just too expensive for all other companies to do human trials. And since the FDA does not require human research on finished nutritional products, nearly all companies opt to not do them, but to simply rely on borrowed research on individual ingredients. But it's vitally important that there be a system in place that provides human safety and efficacy studies on the finished product to be able to provide a high level of predictability. This is, after all, the standards that the FDA holds pharmaceutical companies to because in the drug world consumers want nothing left to chance. And while the world of supplements may not appear to pose the kinds of health threats that contaminated drugs would, we are beginning to see that that may not always be the case. In a world where we now see herbal supplements tainted with drugs or contaminated with yeast, molds, funguses, heavy metals, etc, which can have, in some cases, devastating effects on one's health and even lead to death, consumers should be as concerned about the herbs and vitamins that they put into their bodies as the drugs they take.
The list you have just read is a very partial one. The previous three points represent a much longer list of standards too lengthy to discuss here. But you get the point. Elite quality safety and efficacy standards are rare in the supplement industry. Very rare! And consumers would be well advised to buy supplements only from practitioners who actually practice holistic and integrative medicine in their clinics and who rely on products created for the clinical setting and that are created by companies that adhere to these standards.
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