More Education Needed as Supplements Market Expands

Record use of dietary supplements has not been matched by the oversight of the market. Some industry leaders have stepped up with trusted evidence-based resources to address the knowledge gap.

Dietary supplement usage in the US has reached an all-time high with nearly 80% of American adults reporting they consume them, according to the 2019 CRN Consumer Survey on Dietary Supplements. Americans spend over $30 billion a year on nutritional supplements such as vitamins, minerals, herbal supplements, and products sold for weight loss, performance, or energy enhancement. The herbal supplement market alone saw an 8.6% increase in total US sales in 2019, according to the American Botanical Council’s (ABC’s) 2019 Herb Market Report, and now tops almost $10 billion annually for dietary supplements in which a particular herb is the primary ingredient.

Supplement usage among American children is also significant. The National Health and Nutrition Examination Survey (NHANES), during 2017 and 2018, found that 34% of youth under the age of 18 reported using supplements within the past 30 days. In children and adults alike, supplement use is higher among females.

In the 2012 National Health Interview Survey, the vast majority of American adults reported wellness-related reasons for using dietary supplements, such as general wellness or disease prevention, improved immune function, and improved energy and concentration. Older adults tend to take supplements for organ-specific reasons, such as calcium for bone health or fish oil for heart health. Younger adults are more likely to take supplements for short-term benefits, such as increasing energy or boosting immunity. The most common supplements used by children are multivitamin-mineral products.

Americans spend over $30 billion a year on nutritional supplements.

The ABC Herb Market Report suggests that the COVID-19 pandemic is further bolstering the supplement market. Herbs such as echinacea and elderberry, commonly used for immune support, saw a significant rise in sales in the first half of 2020. Elderberry sales grew by triple digits across all retail outlets, growing by 241% in mainstream retailers such as drug stores and grocery stores, while sales of echinacea products grew by more than 50% compared to the same time period in 2019. Mark Blumenthal, founder and executive director of ABC, says, “These retail sales data demonstrate the continued increase in consumer interest in and demand for herbal dietary supplements, representing a steadily growing trend toward natural health as a solid lifestyle shift, especially proactive attempts to enhance immunity.”

While use of dietary supplements is at record high levels, their use is not without risk. A 2015 study published in the New England Journal of Medicine reported that adverse effects of nutritional supplements were connected to an estimated 23,000 emergency room visits and more than 2,100 hospitalizations per year. A recent review of Food and Drug Administration (FDA) adverse-event data found 22 deaths and 22 substantive disabilities related to use of single-supplement usage over a ten-year period. The same review found that products sold for weight loss, muscle building, or energy enhancement were associated with nearly three times the risk of severe medical outcomes compared with vitamins.

Some dietary supplements may be harmful for people with a particular medical condition or risk factor, or may interact negatively with certain prescription or over-the-counter medications. The herbal supplement St. John’s wort, for instance, reduces the efficacy of a number of medications. Though many dietary supplements come from natural sources, the National Center for Complementary and Integrative Health (NCCIH), a division of the National Institutes of Health, points out that “natural” does not always mean “safe.”

“These retail sales data demonstrate . . . a steadily growing trend toward natural health as a solid lifestyle shift.”

Research shows that most people do not tell their doctors about supplements they take or seek their advice on them. The communication gap goes both ways, as many doctors report not asking patients about supplement use. In addition, there are limited quality standards for dietary supplements, making it challenging for consumers and healthcare providers to discern their safety and quality.

Lax Oversight

Though dietary supplements are commonly used as natural medicines, they are not regulated with the same strict rules as prescription and over-the-counter drugs. The Dietary Supplement Health and Education Act of 1994 established the regulatory framework for dietary supplements, categorizing them as “foods” that are ingested to supplement the diet, rather than drugs. Supplement companies are required to provide evidence their products are safe and do not contain contaminants or impurities and ensure labels are not misleading.

However, unlike pharmaceuticals, the FDA does not require dietary supplements to be tested for safety or efficacy prior to marketing, nor does it establish standards for the contents of these products, such as maximum amounts of nutrients in a multivitamin or what constitutes a botanical supplement extract. As a result, there is wide variability in the amount and composition of ingredients across different products.

Independent third-party certification and verification programs, while not used universally by the industry, fill an important, but limited, quality-assurance role. These organizations—ConsumerLab.com, NSF International, and USP—test dietary supplements as finished products for identity and quality of ingredients, as well as quantity, purity, and freshness. “Dietary supplements are considered safe until proven otherwise, whereas drugs are considered unsafe until proven safe through clinical trials,” says Lori Bestervelt, PhD, and creator of the dietary supplement certification program at NSF. The FDA gets involved in safety enforcement only after reports of serious harm from a product.

Unlike pharmaceuticals, the FDA does not require dietary supplements to be tested for safety or efficacy prior to marketing.

Third-party certification programs are fee-based programs and participation by supplement manufacturers is voluntary. While these programs ensure supplements do not contain ingredients with known safety risks, the assessment of safety risks that involve the inherent nature of the ingredients are beyond the scope of third-party quality certification.

The NCCIH cautions that what’s on the label may not be what’s in the product. Certification marks on product labels by third-party certification programs are currently the best consumer resource for assessing product quality of dietary supplements.

Gaps in Education

The availability of online information about supplements is as widespread as supplements themselves. However, a 2016 article published in the Journal of the Academy of Nutrition and Dietetics, points out that the quality of information “ranges from promotional to academic, and it is often difficult for the reader to discern the difference.” The authors note the supplement industry faces a lack of clarity and agreement about the potential health benefits of supplements, as well as concerns about the quality and safety of these products. Among the reasons they cite are a limited amount of scientific evidence and a lack of financial incentive by the industry to fund additional clinical research, as well as limited formal education for healthcare professionals about dietary supplements.

The NCCIH cautions that what’s on the label may not be what’s in the product.

Research has shown that communication between patients and physicians about dietary supplements has not kept up with the growth in supplement use. A small study conducted at the University of North Carolina Medical Center evaluated dietary supplement use by hospitalized patients and related patient-physician communication. During hospital admission, 78% of patients reported using dietary supplements, and of those, 75% did not inform the admitting physician about their use of supplements. When asked their reasons for not reporting their supplement use, 56% of patients said they felt the information was unimportant. Three-quarters of patients reported that no physician inquired about their supplement use, and only 9% of patients reported telling the admitting physician about their supplement use despite not being specifically asked. This study is consistent with research from Israel that found only 6% of patients were specifically asked about supplement use during the admission process, suggesting a lack of training among resident physicians on the potential for adverse interactions between dietary supplements and pharmaceutical drugs.

In a study that examined the knowledge, attitudes, and practice patterns of oncologists regarding patient use of herbs and supplements, researchers found that 59% of oncologists had not received any education about the topic. Many botanical supplements can interfere with chemotherapy efficacy and/or increase the risk for treatment-related toxicity and other complications. When asked about four specific interactions between herbal supplements and chemotherapy, only one-third of oncologists correctly answered at least three of the four questions. Although patients with cancer commonly use complementary and alternative medicine protocols, including herbal supplements, two of three oncologists said they did not have enough knowledge to answer questions from patients on the topic, and only 26% initiated discussions about use of herbs and supplements with their patients. Many oncologists in the study indicated lack of knowledge and education as a barrier to such discussions.

Communication between patients and physicians about dietary supplement use has not kept up with the growth in supplement use.

Lack of education on dietary supplements is not limited to physicians. A 2020 survey conducted by TRC Healthcare involving more than 2,500 healthcare professionals made up primarily of community and hospital pharmacists, as well as a small number of nurse practitioners, specialty clinic staff, and ambulatory care staff, found nearly 70% are asked about natural medicines on at least a weekly basis. More than 35% said information on supplements is difficult to find, and the vast majority of respondents—nearly 80%—said they rely on internet searches for their information.

Along with education for healthcare professionals, a recent article published by Health Affairs highlighted the need for consumer education as an important complement to legislative reforms to prevent injury from dietary supplements. While trusted, quality information is difficult to find, some companies are attempting to address the knowledge gap.

Filling the Knowledge Gap

TRC Healthcare (https://trchealthcare.com/), based in Denver, provides healthcare professionals original, independent, clinically referenced recommendations and education on drug therapy and medication management to reduce medication errors and improve patient care. For more than 35 years, TRC has supported the therapeutic decisions of more than 90,000 healthcare providers, 250,000 pharmacists, and 180,000 technicians with their up-to-date, evidence-based, unbiased recommendations on drug therapy.

While trusted, quality information is difficult to find, some companies are attempting to address the knowledge gap.

TRC Healthcare’s Natural Medicines^TM   database  is considered one of the most authoritative resources available on dietary supplements, herbal medicines, and complementary and integrative therapies. The company says its data is built on the best available scientific evidence, which is critically evaluated using the same standards that relate to other therapies, to curtail the perpetuation of myths and age-old beliefs about natural medicines and replace them with reliable scientific data. Each natural medicine monograph contained in Natural Medicines provides safety ratings, effectiveness ratings, and interaction ratings. These ratings are assigned based on strict evidence-based criteria. Updated on a daily basis, the Natural Medicines database also offers interactive tools such as a drug/herb interaction checker, an adverse-effects checker, and a nutrient-depletion checker, for over 1,400 natural ingredients found in more than 185,000 dietary supplements, natural medicines, and integrative therapies.

As a direct result of their 2020 survey of healthcare professionals, TRC Healthcare is developing a new program—RxAdvanced: Guide to Natural Medicines—to provide training on natural medicines to improve communication confidence and patient outcomes. The program is expected to launch in spring 2021 as part of their continuing education and training programs.

TRC Healthcare’s Natural Medicines^TM database is considered one of the most authoritative sources available on dietary supplements.

TRC Healthcare has also partnered with KnoWEwell® (https://www.knowewell.com/), the global Regenerative Whole Health™ benefits and services company. KnoWEwell is an online community and marketplace that educates and empowers individuals with today’s Regenerative Whole Health knowledge and resources to prevent harm, address chronic diseases and achieve WELLthier Living™. It bridges the knowledge gap by connecting the dots between soil, food, lifestyle choices, and planet and people health. KnoWEwell is raising the standard and credibility for the Regenerative Whole Health industry by screening its provider members, delivering expert-led and peer-reviewed content, offering immersive learning, and fostering connections amongst its individual and provider members.

As part of the partnership between KnoWEwell and TRC Healthcare, all KnoWEwell members have basic access to TRC Healthcare’s 1,400 natural medicines for consumer and practitioner education. Members with upgraded membership receive access to TRC Healthcare’s extensive Natural Medicines database and interactive tools. In addition, TRC Healthcare’s RxAdvanced Guide to Natural Medicines program will be available on KnoWEwell’s platform for purchase this fall.

Consumers and professionals can make safe, informed choices about dietary supplements by seeking out trusted sources such as these, and by following these five basic safety guidelines from the NCCIH:

1. Be an informed consumer by researching the scientific evidence for the safety and efficacy of the supplement you plan to take.
2. Be educated about supplement labels. Terms like “natural,” “standardized,” “verified,” or “certified” do not guarantee product quality or consistency.
3. Interactions with medications are possible and some supplements may have side effects of their own.
4. Be aware of the potential for contamination, particularly in weight loss, sexual health, and athletic performance supplements.
5. Above all, talk to healthcare providers about use of any dietary supplements to better ensure safe, coordinated healthcare.