Once again nutritional supplements are in the news, this time the attorney general of New York State has threatened legal action against four leading chains (GNC, Target, Walgreens and Walmart) for selling mislabeled products. According to the report from New York attorney general Eric Schneiderman, investigation of store brand herbal products revealed that only 21% of herbal products contained DNA of the plants purported by the label, including the commonly used herbs Echinacea, Ginseng and Ginkgo biloba.
Though supplement quality is known to vary widely, the New York investigation has been criticized for using potentially inaccurate assessment methodology. In a formal statement by Council for Responsible Nutrition, president Steve Mister cites the methods favored by botanical scientists for detecting plant material in products, stating that “…different identification test methods, from simple titration to chromatography and mass spectrometry, are appropriate for different stages of the processing—from the whole plant to the extract, to the finished product.” Measuring DNA of the finished product may not be an accurate method of detecting presence of plant material in supplements. Harvard expert on nutritional supplements, Dr. Pieter Cohen, commented that the investigation results were so extreme that they were likely inaccurate, and it was possible that the tests had failed to detect the presence of plants because the manufacturing process had destroyed their DNA. There is a precedent for using DNA barcoding in investigation of herbal supplements from a 2013 Toronto study, which found below 50% accuracy in label claims for the products investigated.
While nutritional supplements in the United States are technically regulated by the FDA through the Dietary Supplement Health and Education Act (DSHEA) of 1994, the law is not fully implemented to regulate dietary supplements for quality. As required by DSHEA regulations, dietary supplements are required to follow FDA Good Manufacturing Practices (GMP) guidelines, which apply to pharmaceuticals as well as supplements. In the years since DSHEA was passed, legislation calling for more stringent quality control have been introduced and voted down. Critics of amending DSHEA claim that regulation of supplements as drugs will restrict consumer access and drive up costs. On the other side, critics of DSHEA cite the multitude of safety issues with supplements causing illness and even death, and the problematic atmosphere created by DSHEA which allows for a free-market with the onus for quality control and safety on the profit-driven manufacturer. In a recent article by Harvard’s Dr. Cohen: “DSHEA creates perverse incentives for unscrupulous manufacturers to out-compete legitimate companies by adding undeclared, illegal ingredients including prescription medications, banned drugs and even entirely novel chemical compounds.” Advocates of greater implementation of DSHEA point out that the the regulatory processes created by the original legislation have never been enforced, and rather than amend the legislation it should be fully funded and implemented. For example, DSHEA stipulates that for new products (introduced since 1994), manufacturers must provide the FDA with evidence supporting a “reasonable expectation of safety.” This aspect of DSHEA has never been enforced.
There are several components of FDA regulation of nutritional supplements to consider. First is the accuracy of labeling and whether the contents of the bottle match what the label claims. Because the FDA does not have systems in place to implement DSHEA by regulating manufacturing content, there is little oversight beyond independent watchdog companies such as Consumer Labs analyze products and report on accuracy of labeling. Consumer Labs leads the field in independent product analysis, primarily using chromatography and mess spectrometry to analyze nutritional supplements for content. In addition to reporting on accuracy of label claims, Consumer Labs also reports on the presence of potentially hazardous substances like allergens and toxins.
Next, the role of the FDA (and potentially the DEA) is to ensure that no drug contaminants are incorporated in dietary supplements. In 2004, regulations were passed to ban ephedra and anabolic steroids from dietary supplements. An international study published in 2004 revealed that as much as 15% of dietary supplements contained pro-hormone, anabolic contents that were not declared on the label. Because pre-approval is not required for supplement sales, these contaminants are not detected until products have already been available on the market. Safety issues are only brought to light through consumer reporting or through medical intervention after serious adverse effects occur.
Finally, dietary supplement safety involves product efficacy, which is presently not required under DSHEA. The FDA does restrict claims made for the health benefits of nutritional products but does not require pre-approval of sales based on efficacy data. This matter was recently raised by the Federal Trade Commission against Dr. Mehmet Oz was for making unfounded claims about the health benefits of supplements. While the body of data for evidence-based complementary and alternative medicine is growing, there is a relative lack of clinical evidence for herbal and nutritional supplements. Without the support of clinical trials to verify safety and efficacy, any health claim made by a dietary supplement – especially the more fantastic the claim – might very well be too good to be true.
Beyond the safety issues of quality control and the efficacy of nutritional supplements are concerns over herb-drug or nutrient-drug interactions with medications, and contraindications with other health conditions. Safety warnings about known adverse effects, interactions and contraindications are required by the FDA regulations under DSHEA. The burden of proof falls on the FDA to ensure that these requirements are being met, and due to inadequate resources this may not be upheld.
Fortunately, naturopathic physicians are experts in the field of dietary supplement safety and efficacy, and are an excellent resource for information about nutritional supplements as well as prevention of interactions and contraindications. To address the many concerns about supplement quality, safety and efficacy discussed above, in my practice I almost exclusively recommend professional-line nutritional supplements that are manufactured with the highest possible standards. This means that the supplement manufacturer meets the following criteria:
- independent, third-party analysis of their product
- verified analysis of the suppliers of their raw material
- adherence to GMP
- routine batch testing of their products
- potency testing to verify dosing of label claim
- sufficient testing to confirm absence of contaminants
- verification of stability of shelf-life for their product
- evidence of total quality
- often, participation in clinical trials to demonstrate the efficacy of their product
Some nutritional supplements sold over-the-counter meet some of these criteria, but very few or none meet all of them. The only way to guarantee product safety is to choose nutritional supplements that elect to uphold the highest standards of quality, not because they are required to so by the inadequate implementation of DSHEA, but because they prioritize scientific research and rigorous standards.
There are dozens of professional-line ‘nutriceutical’ manufacturers that meet these criteria, and many of them dispense only to licensed providers or natural pharmacies. One such dispensary that only contracts with licensed providers and distributes top-quality nutriceutical products is Emerson Ecologics. Their quality standards, the Emerson Quality Program requires all manufacturers to submit to third-party analysis of their products. Beyond the basic quality standards, Emerson Ecologics also Silver and Gold Partner quality standards which meet the criteria listed above, which is what I look for in making recommendations for top-quality supplements for my patients.
As experts in nutritional supplement safety and efficacy, naturopathic doctors have long been involved with the political side of supplement regulation. The American Association of Naturopathic Physicians has long advocated for the full implementation of DSHEA, but opposes legislation that would restrict access to supplements or regulate them as drugs. Because nearly 70% of Americans are taking some form of nutritional supplement, we support the FDA to fully and appropriately regulate them according to the purview of this legislation.
Additional Resources:
Natural Product Association
Council for Responsible Nutrition
National Institute of Health, Office of Dietary Supplements
Diana Quinn ND 