Supplement Adulteration: What You Need to Know
The popularity of dietary supplements continues to grow, with 80% of U.S. adults taking dietary supplements, according to the Council of Responsible Nutrition USA. Supplements, functional foods, and ingredients to fortify dietary nutrition are ways consumers attempt to empower their healthy life choices. We scavenge through articles, websites, and newsletters on the elusive quest for the perfect balance of vitamins, minerals, and superfoods to help us achieve better health.
In 2021, the dietary supplements market was valued at USD 151.9 billion in 2021, according to Grand View Research, and poised for continued growth. Although high profit margins matter in the supplement industry, product quality, safety, and efficacy are top of mind. At times, adulterated supplements may result from using low-quality ingredients or less expensive processes to elevate profits, but adulteration may not always be deliberate. It's essential for supplement manufacturers to understand why adulteration is a problem and how to prevent it.
The Problem of Supplement Adulteration
At its most heinous, adulteration of supplements includes adding potentially unsafe active pharmaceutical ingredients (API) to boost perceived efficacy. This problem is documented most notably in the weight loss and sexual enhancement supplement industry. For example, weight loss supplements tested in United Arab Emirates (UAE) showed that 17.5% contained undeclared sibutramine, phenolphthalein, or fluoxetine. (Jairoun et al., 2016). Adulterated supplements pose an even greater risk to consumers who take more than the recommended doses as they may consume high levels of these toxic substances.
The Food and Drug Administration (FDA) discovered undeclared drugs in 572 supplements between 2007 and 2014 across several product categories. More recently, an FDA Public Notification from July 30, 2021, an example of FDA adulteration, showed 365 Skinny High Intensity contains hidden drug ingredients. The found ingredient, sibutramine, was removed from the market in October 2010 for safety reasons. An FDA Drug Safety Communication, through clinical trial data, showed this drug poses a risk to consumers with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. Sibutramine may increase blood pressure and/or heart rate in some people.
Most supplement manufacturers are diligent in preventing adulteration and being mindful of cross-contamination and ingredient degradation as adulterated supplements can be harmful to the people taking them. Mislabeled supplements mislead consumers, leaving them vulnerable to taking ingredients that may cause them harm. Medical and non-medical ingredients may interfere with prescription medications, medical conditions as well as other ingredients in the diet. An example cited by the National Institutes of Health is St. John's wort may degrade the effectiveness of medicines, including some antidepressants and heart medications. Similarly, an accidental interaction from too much vitamin K may reduce the blood-thinning action of warfarin which is meant to prevent blood clotting post-surgery.
Addressing Supplement Adulteration
According to the FDA, adulteration occurs when a dietary supplement has been prepared, packed, or held under conditions that do not meet current good manufacturing practices (cGMP) regulations. As noted above, there is economically motivated adulteration which might include adding API for product enhancement, substituting less expensive ingredients, or diluting ingredients. Economically motivated adulteration of supplements is purposeful to sell more and save money along the supply chain.
It is noteworthy that there may be unintentional and accidental adulterated supplements. Issues related to microbiology and cross-contamination of allergens or pesticides are challenges for preventing adulteration. According to the National Institutes of Health Dietary Supplements Fact Sheet, the FDA has established good manufacturing practices for companies to help ensure the identity, purity, strength, and composition of their dietary supplements. These practices help prevent adulteration by adding the correct amount of the right ingredient and minimizing contamination risk while promoting proper packaging and labeling of products.
Testing for adulteration of supplements is important for consumer safety. Naturally derived botanical dietary supplements, for example, are very complex. This is due to geography, growth stage, plant part differences as well as genetic diversity among different species. Processing and manufacturing methods can furthermore change ingredient potency and purity while phytochemical constituents may interfere with each other. Economically motivated adulteration of ingredients may be unknowingly passed on to the supplement manufacturer when purchasing botanicals. Testing for identity, composition, purity, potency, and contaminants will help prevent adulteration for the manufacturer and, ultimately, the consumer.
Reliable Testing for Preventing Adulteration
Products are, by definition, adulterated if they don't meet the finished product, ingredient, or labeling specification. Whether this is on purpose or by accident, ingredient and product testing is essential to prevent the adulteration of supplements. Notably, the FDA periodically inspects facilities that manufacture supplements. For manufacturers, having detailed and accurate testing documentation may facilitate these processes.
Supplement manufacturers focused on preventing adulteration trust Eurofins network of ISO 17025 accredited laboratories as the global leader in biological testing with 200,000 reliable analytical methods for characterizing the safety, identity, purity, composition, authenticity, and origin of products. Our diverse laboratories navigate seamlessly through a dynamic and ever-changing global marketplace.
