The dietary supplement, functional food, and natural products industries in the United States are facing numerous regulatory uncertainties with the start of 2021, which is marked by a new US Administration, ongoing global pandemic, and much more. Most importantly, the FDA does not have authority to review dietary supplement products for safety and efficacy before marketing. Herbal products are not tested under the scientific rigor required for traditional drugs, nor are they subject to FDAs approval process.
Manufacturers of these products are not required to submit evidence of safety and effectiveness to the U.S. FDA prior to marketing. The Dietary Supplement Health and Education Act of 1994 allows labeling herbal products with statements explaining their claimed effects on human body structures or functions (e.g., relieving fatigue) or their role in contributing to overall wellbeing (e.g., improving mood or mental functioning). Analysis of some herbal products claimed effects has shown they are at times highly similar to claims about clinical effectiveness in a variety of diseases or conditions. Therefore, herbal products may not be marketed to diagnose, treat, cure, or prevent diseases. Dietary supplements are subject to stricter manufacturing and quality-control regulations than foods, and must thus be manufactured at CGM-compliant manufacturing facilities approved to manufacture food additives.
Texas does not consider vitamins or dietary supplements food products, but rather considers them medical supplies, which are exempt from sales taxes. It should be noted that nutritional supplements were exempt before the 2005 repeal of the South Dakota exemption. The next most popular supplements are herbs and botanicals, followed by sports nutrition supplements. Supplements are divided into several categories; by far, vitamins and minerals are the most popular, with specialty supplements being second.
Sports supplements are niche markets; not that non-athletes cannot benefit from these products, but that their target market is athletes. With over 90,000 different supplements on the market, it can be confusing to figure out which ones are safe and which ones are not. If you are not sure of a supplements or herbs safety, speak to a health care provider, pharmacist, or nutritionist. This is important, since supplements do not need to undergo the same rigorous testing as prescription medications.
Herbal Dietary Supplements in Virginia and Maryland
As you learned above, that means a supplement maker makes a vitamin, then an Amazon Elementals label is attached. If you recall, online retail behemoth Amazon bought Whole Foods years ago, so it is where you will also find vitamins. Common supplements in diets include vitamins and minerals (such as Vitamin C or multivitamins), botanicals (herbs and botanical products, like St. Johns Wort), and substances derived from a natural source (such as omega-3 fatty acids). GOED is proud of the members steadfast commitment to producing quality omega-3 supplements, pandemic or not.
As an organizing body for standards that seeks to advance public health, the U.S. Pharmacopeia supports manufacturers of food additives in continuing their efforts to produce high-quality products that address the needs of consumers. We encourage the Agency to publish final new dietary ingredient (NDI) guidelines offering protections to innovation and research; establish and clarify the legal pathway for hemp-derived cannabidiol (CBD) as a dietary supplement; implement mandatory product listings providing transparency for regulatory agencies and consumers alike; and address issues regarding N-acetyl-l-cysteine (NAC) and other ingredients shared between supplements and medications. The GAO was asked to determine (1) whether sellers of herbal dietary supplements are using deceptive or dubious marketing practices, and (2) whether selected herbal dietary supplements are contaminated with harmful substances. This includes only products that fit the statutory definition of a dietary supplement under the U.S. Food and Drug Administrations (FDA) regulations, with the exception of products that contain cannabidiol (CBD), as explained below.1 Sales of herbal teas or beauty products containing botanical ingredients were excluded.
NBJ provides estimates for the total annual sales of herbal supplements, along with sales across the three channels of distribution (mass-market; natural, health, and specialty; and direct-to-consumer) and sales by type of product (single-herb supplements versus combined formulations).
Having a USP-verified mark on the label of a supplement means the supplement has been examined, and contains the ingredients listed on the label at the strength and quantity that the brand claims. These claims are 100% legitimate, and they may suggest to consumers that a supplement could protect them against COVID-19, but it does not, explains Peter Cohen. Because COVID-19 is still going to be the top issue in 2021, we can expect to see similar issues with unscrupulous actors making baseless claims on their products marketed fraudulently as food supplements in 2021. These factors may lead to increased risks for poor-quality ingredients and production practices, and increased opportunities for financially motivated bad actors to produce adulterated dietary supplements.
In 2020, FDA issued nearly 200 warning letters and other actions against dietary supplement companies, for reasons including making unsubstantiated claims, mislabeling products, failing to comply with CGMP standards, or selectively dispensing adulterated raw materials and using them in finished products. According to SPINS, consumers on natural channels spent the most on quercetin supplements for allergies and respiratory health in 2020, followed by cardiovascular health and prostate health. The market for quercetin supplements for immune health, which accounts for the smallest share of sales for quercetin supplements, also saw sales grow 59.2% in 2020.
In 2020, sales of these products, which comprise food additives containing herbs and/or fungi ingredients, increased a record-breaking 17.3 percent from 2019–the first time that such products had experienced double-digit growth for at least the last two decades. Apple cider vinegar (ACV) (Malus spp., Rosaceae) is the only other herb-based dietary supplement ingredient that has experienced more than a 100% sales growth in major retail outlets since 2019.