The increase in consumer interest has also accompanied an increase in industry interest in producing dietary supplements and there has been a proliferation of new dietary supplements companies in recent years. Indeed, Forbes magazine suggests that the supplement industry is one of the fastest growing industries in the world and estimates that, by 2021, supplement revenue will double that of 2013.[2]
The U.S. Food and Drug Administration (FDA) does not determine whether supplements are effective before they are made available for purchase and consumption, so consumers are often left to their own devices when deciding what products to use. The rapid growth in the dietary supplement market combined with relatively lenient regulation sometimes results in inferior product quality, and occasionally, adverse patient outcomes. Thus, the onus must be on manufacturers to ensure that their products are safe and on healthcare providers to ensure that their patients are using safe and effective products.
Supplement Regulation in the United States
The most significant form of government regulation on supplement manufacturers was the Dietary Supplement Health Education Act (DSHEA) passed in 1994. This new law, which amended the Federal Food, Drug, and Cosmetic Act, created a new regulatory framework for the safety and labeling of dietary supplements. Under DSHEA, a firm is responsible for determining that the dietary supplements it manufactures or distributes are safe and that any representations or claims made about them are substantiated by adequate evidence to show that they are not false or misleading. . The 1994 DSHEA also authorized FDA to develop CGMP regulations for dietary supplements.
These regulations were finalized in 2007 as 21 CFR Part 111 cGMP (1)and focus on practices that ensure the identity, purity, quality, strength and composition of dietary supplements and ensure accurate labeling, packaging, holding, and the manufacturing process for supplements to prevent contaminants and impurities from being in the final product. While the FDA has these requirements for supplement manufacturers, they rarely engage in third party testing of the products, so companies are generally left to police themselves. Due to the challenges of self-policing, some companies opt for voluntary third party testing and certification to ensure compliance with cGMP, and to demonstrate their commitment to producing high-quality products. It is particularly compelling to note that only 12% of mainstream over-the-counter dietary supplements are actually tested by third parties.[3]
Quality Matters
In February 2015, the FDA started a review of dietary supplement companies. The FDA reported discovering instances of adulteration of product or misleading marketing information, and had taken action against 117 supplement manufacturers.[4] The charges at the time included supplements that did not contain any active ingredients and supplements that had inaccurate ingredient labels. These examples underscore that quality nutritional supplements must be sought out from reputable sources and that supplement manufacturers must adhere to federal guidelines and certifications for optimal public safety and efficacy.
The Children’s Hospital of Philadelphia (CHOP) and other healthcare providers have also taken action to ensure that their patients only take high-quality supplements. As reported in the January 2016 Frontline public broadcasting episode entitled “Supplements and Safety”, it was noted that CHOP requires supplement manufacturers provide them with a certificate of analysis on the content of their product(s). After further assessment by the hospital’s pharmacists, only 35 over-the-counter dietary supplements met their standard of use, based on ingredient quality, dosage, and label accuracy. This instance with CHOP provides an instructive example of the collaboration between healthcare provider and supplement manufacturer to ensure that only the highest-quality supplements make it to the consumer.
Interest in health and wellness is growing amongst Americans, and dietary supplementation is a promising and convenient therapeutic option for optimizing health, reducing healthcare utilization, and preventing disease. However it is incumbent upon healthcare providers and patients to seek out those supplement manufacturers with strong commitment to quality products.
How to Identify a High-Quality Dietary Supplement
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Before purchasing a supplement, know the optimal form of the nutrient sought
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Read the label to identify ingredients, and identify whether the nutrient forms are synthetic or natural, and identify the dose of the ingredients
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Seek out dietary supplements that are manufactured by CMP-Certified companies partaking in voluntary third-party product testing of their finished products and ingredients
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Healthcare providers and patients should remain in close contact to manage any unexpected or adverse events and to make adjustments to the dietary supplement regimen if necessary
*These statements have not been evaluated by the Food and Drug Administration
This information is for educational purposes only. The statements have not been evaluated by the Food and Drug Administration and are not intended to diagnose, treat, cure, or prevent any disease. Consult your physician if you have any question regarding a medical condition
