Shopping for dietary supplements at a drugstore or online can feel like shopping blindfolded. How are we as consumers supposed to know what brands actually contain active ingredients and what brands are better?
A recent New York State Attorney General investigationexamined the contents of multiple store-brand herbal products at four major retailers. The researchers tested echinacea, ginseng, St. John's wort, valerian root, garlic, ginkgo biloba and saw palmetto using DNA barcoding and found that many of the supplements contained only contaminants and cheap fillers.
4 out of 5 bottles contained none of the herbal ingredient on the product label. Researchers found contaminants ranging from dracaena, a houseplant, to asparagus, rice, and spruce. Some bottles that were mislabeled gluten-free and others contained allergens like nuts and citrus. Here is the breakdown of the results:
Walmart (4% matching the product label, 40% tested for botanical material not on label, 56% no plant DNA at all)
Walgreens (18% matching the product label, 45% tested for botanical material not on label, 37% no plant DNA at all)
GNC (22% matching the product label, 33% tested for botanical material not on label, 45% no plant DNA at all)
Target (41% matching the product label, 21% tested for botanical material not on label, 38% no plant DNA at all)
The cease and desist letters sent to these companies reveal an overwhelming mismatch between product label and actual content. For example, Walgreens’s ginseng, marketed to improve energy and vitality, had no ginseng at all-- only garlic (“allium”) and rice (“orzya”). Walmart’s gingko biloba, purported to improve memory, contained only radish, the houseplant dracaena, and wheat. A GNC-branded St. John's wort had no trace of St. John's wort-- only rice, garlic, and dracaena. Target’s valerian root had no valerian root-- only fillers like beans, peas, rice, and wild carrot. These findings are consistent with prior research that at least a third of herbal supplements do not contain the herb listed on the label.
Nearly half of American adults use dietary supplements, and at least 1 in 5 people take herbal supplements (Bent 2008). Most consumers do not realize that dietary supplements and their marketinghealth claims are not strictly regulated by the U.S. Food and Drug Administration (FDA) unlike prescription drugs. Experts have pointed out that the lack of strict regulation of the dietary supplement industry has led to a “veneer of legitimacy” and deceptive marketing practices that are often not backed up by scientific clinical evidence.
Dietary supplements, including vitamins, omega-3 fatty acids, herbals, and botanicals, are not required to go through clinical trials to prove safety or effectiveness before reaching consumer shelves. The Dietary Supplement Health and Education Act of 1994 (DSHEA) prohibits manufacturers and distributors of dietary supplements from marketing products that are adulterated or misbranded, but manufacturers themselves are responsible for evaluating the safety and labeling of products—not the FDA. The FDA instead bears the burden of proof to show a supplement is unsafe before it can be taken off the shelves (Dietary Supplements 2005). In contrast, prescription medications must undergo rigorous preclinical animal testing, human clinical trials, and rigorous review of its safety and effectiveness to meet FDA requirements for marketing approval before it ever reaches consumers.
Many of these herbal and dietary supplements are marketed for mental and psychological benefits—with claims that they improve memory, energy, or mood. While there is growing and important body of research for some dietary supplements (e.g., omega-3 fatty acids, as supplemental therapy along with antidepressants to treat depression), the clinical evidence for the effectiveness of many dietary supplements is often conflicted or more nuanced than the broad marketing health claims of manufacturers. In a 2012 Department of Health and Human Services study of 127 dietary supplements marketed for weight loss and immune support, the study found that 20% included prohibited claims on the label.
Previous research has also raised the issue of dangerous and toxic contaminants in dietary supplements. One study of herbal products from Asia found that 25% of the products contained high levels of toxic heavy metals, and 7% contained drugs not declared on the label, which had been intentionally and illegally added (Ko 1998). Methamphetamine analogs, known to be addictive, have even been found in so-called natural pre-workout supplements (Cohen et al. 2014).
Even when the products contain what is advertised, consumers face additional challenges, including a wide variation in potency. One study of ginseng compared 25 products and found that they varied between 15- to 200-fold in the chemically active ingredients, leaving consumers in the dark.
The FDA also faces barriers in being able to protect the consumer, including the problem of underreporting of adverse events and its limited authority to recall a dangerous supplement. A 2009 report from the U.S. Government Accountability Office notes that the FDA’s ability to regulate is curbed by its limited information and access to the number and location of dietary supplement firms, types of products on the marketplace, and adverse events. Even when the FDA has identified a safety concern, the FDA lacks “mandatory recall authority” and must demonstrate “significant or unreasonable risk for specific ingredients.”
The combination of the FDA’s lack of oversight and authority and the high threshold to demonstrate safety risks for dietary supplements means that it can take over a decade to remove a known dangerous product from the shelves. This was evident in the case of ephedra-containing herbal weight loss pills—a supplement that caused hundreds of fatalities and thousands of adverse events. (Shekelle et al. 2003, FDA 2004). Regulatory and medical authorities have repeatedly called for increased regulation and oversight of the product, marketing, and consumer education.
How can consumers compare dietary supplement brands?
One website consumerlabs.com reviews supplement brands, but it requires paid membership to be able to access product and quality information on brands. A website from the Office of Dietary Supplements recommends asking the manufacture these questions before purchasing a supplement:
- What information does the firm have to substantiate the claims made for the product? Be aware that sometimes firms supply so-called "proof" of their claims by citing undocumented reports from satisfied consumers, or graphs and charts that could be mistaken for well conducted scientific research.
- Does the firm have information to share about tests it has conducted on the safety or efficacy of the ingredients in the product?
- Does the firm follow good manufacturing practices and have a quality control system in place to determine if the product actually contains what is stated on the label and is free of contaminants?
- Has the firm received any adverse events reports from consumers using their products?
But this cumbersome system hardly seems like a user-friendly solution.
There are a few independent third-party certification companies that offer certification, including Consumerlab.com, NSF International, and U.S. Pharmacopeia. However, one of the companies, US Pharmacopeia, has reported that fewer than one percent of manufacturers participate in its certification process.
The recent study and prior research all point to the pressing need for increased consumer access to accurate brand information along with dietary supplements that actually contain what is on the label.
References
Bent, S. Herbal Medicine in the United States: Review of Efficacy, Safety, and Regulation. J Gen Intern Med. 2008 Jun; 23(6): 854–859.
Cohen PA, Maller G, DeSouza R, Neal-Kababick J. Presence of banned drugs in dietary supplements following FDA recalls. JAMA. 2014 Oct 22; 312(16):1691-3.
Cohen PA, Travis JC, Venhuis BJ. A synthetic stimulant never tested in humans, 1,3-dimethylbutylamine (DMBA), is identified in multiple dietary supplements. Drug Test Anal. 2014 Oct 8.
Cohen PA. Hazards of hindsight--monitoring the safety of nutritional supplements. N Engl J Med. 2014 Apr 3; 370(14):1277-80.
Cohen PA, Travis JC, Venhuis BJ. A methamphetamine analog (N,a-diethyl-phenylethylamine) identified in a mainstream dietary supplement. Drug Test Anal. 2014 Jul; 6(7-8):805-7.
Dietary Supplements: A Framework for Evaluating Safety. Washington, DC: National Academies Press; 2005.
Food and Drug Administration, HHS. Final rule declaring dietary supplements containing ephedrine alkaloids adulterated because they present an unreasonable risk. Final rule. Fed Regist. 2004 Feb 11; 69(28):6787-854.
Harkey MR, et al. Variability in commercial ginseng products: an analysis of 25 preparations. Am J Clin Nutr. 2001 Jun; 73(6):1101-6.
Ko, R.J. Adulterants in Asian patent medicines. N Engl J Med. 1998 Sep 17; 339(12):847
Marcus, D.M. and Grollman, A.P. The Consequences of Ineffective Regulation of Dietary Supplements Arch Intern Med. 2012;172(13):1035-1036.
Shekelle PG, et al. Efficacy and safety of ephedra and ephedrine for weight loss and athletic performance: a meta-analysis. JAMA. 2003 Mar 26; 289(12):1537-45.
