|A recent study on herbal supplements serves as another cautionary tale about
dietary supplements, an underfunded FDA, and a marketplace out of control.
Very troubling news about companies that are not selling what consumers think they are buying.
Last week my local public radio station aired an hour-long segment on herbal supplements. Herbal supplements are big business in the US with approximately 29,000 products on the market and Americans spending an estimated $5 billion annually on them. Scientists at the University of Guelph, Ontario, recently published results of a study of 44 herbal products that used a technique, DNA barcoding, to verify the products' ingredients. A staggering majority of herbal supplements were found to be diluted or replaced with fillers. Here are the quick findings:
- Of the 44 herbal products tested (all 44 sold by 12 companies), nearly 60 percent of the products contained plant-based ingredients not listed on the labels.
- In nearly one-third of the products, the marketed herb was completely replaced with another plant substitute. (No trace of the advertised herb was found.)
- Over one-fifth of the 44 products tested contained fillers that WERE NOT LISTED on the ingredient labels. These fillers were derived from wheat, soy, or rice.
Altering ingredients is potentially harmful to those who use supplements as part of their daily health regimens or management plans for their ailments. And it is downright deadly for those with food allergies. How is it possible that herbal supplements can get away with this?
First of all, herbal supplements (like vitamins and other dietary supplements) are categorized as food not drugs in accordance with the Dietary Supplement Health and Education Act of 1994. Because they are not considered drugs, supplements are not subject to the same rigorous FDA safety and effectiveness testing done for new drugs.
Supplements are categorized as food so they must follow certain standards. Under the Food Allergen Labeling and Consumer Protection Act of 2004, all food products regulated by the FDA must meet specific guidelines for listing the most common 8 food allergens (milk, egg, soy, wheat, fish, shellfish, peanuts, tree nuts) on ingredient labels. Herbal supplements fall under the food product category so -- in theory -- they must follow the FALCPA mandate and be forthcoming with listing the most common food allergens on their labels.
The 2008 Current Good Manufacturing Practices (cGMPs) established new regulations that require dietary supplement manufacturers to undertake numerous tests during the production process. Many manufacturers makers source the ingredients for their product from third-party suppliers including suppliers from foreign countries. The cGMPs hold companies responsible for testing all incoming components for their products to make sure that the components match exactly what they had ordered. Only after verifying the accuracy of the ingredients should supplement manufacturers use the ingredients to create their supplements. Finished batches of supplements must also be tested.
The enactment of food allergy labeling (FALCPA) and guidelines for testing (cGMPs) should ensure that the supplements are what they say on the labels, right?
It should. But officials with the FDA itself assert that a great portion of the dietary supplement industry continues to be non-compliant with the cGMP mandate. And the severely underfunded and overextended FDA admits it does not have the means to check all products coming into the marketplace. (DNA barcoding and Enzyme-Linked Immunosorbent Assay (ELISA) for food allergens are expensive.) The FDA are largely reliant on the diligence of consumers to report suspected bad products and the good faith of companies to offer honest, safeguarded products.
A doctor/presenter that I heard speak at the recent Food Allergy Bloggers Conference confirmed that most errors in labeling/ingredients are caught by the manufacturers themselves through their own independent testing. Recalls are voluntarily initiated by these food manufacturers. She reasoned that companies are forthcoming because it is in their best interests to resolve accidental mislabeling of food allergens -- they do not want to damage their good reputation among their customer base. I admit, this revelation does not sit comfortably with me at all.
The University of Guelph's study shows us that we should not have faith in herbal supplements: herbal companies are slipping through the cracks with watered-down products whose labels are incomplete, inaccurate, and just plain dishonest. The study reminded me of the tainted infant formula scandal in China from several years back. Dishonest producers and non-existent food safety regulations led to the illness of 300,000 people, over 50,000 of them being infants.
I was never much of a supplements kind of gal. And with this latest disturbing report, I don't think I will be anytime soon. The more I read and listen, the more I worry about the safety of any manufactured food product. We shouldn't have to wait until someone ends up sick or dying to know the truth about what we are putting into our bodies.
If you don't have time to listen to the audio segment of the talk, the New York Times published a nice summary of the University of Guelph's study and implications here.