Natural and Herbal Supplements
This review reviews regulation of herbal supplements, examines the potential risks associated with herb use, and provides recommendations for athletic trainers regarding issues related to patient care. It is important to keep in mind that herbal supplements are not subject to FDA regulations, and thus, they are not tested in an FDA clinical trial to demonstrate effectiveness for treating or managing a health condition. This is because herbal supplements are not subject to clinical trials, nor are they held to the same manufacturing standards as traditional prescription drugs or over-the-counter medications. Herbal supplements are not subject to the same standards of testing, manufacture, labeling, and regulations that drugs are.
Herbal supplements typically do not get as much scientific review or are not subjected to as much strict regulation as medications. Herbal supplements are regulated by the FDA, but not as rigorously as prescription or over-the-counter (OTC) medications. Compounding this rise in accessibility and usage are state regulations limiting FDAs ability to regulate any product labelled as a supplement. Some herbal products can be beneficial in the sports context; however, the FDAs current regulations are unable to guarantee the safety and efficacy of products.
Determining the safety and effectiveness of herbal products continues to be challenging, as FDA, manufacturers of herbal supplements, and herbal experts differ over how to interpret the differing evidence that is available for many types of herbal treatments. Because of limited regulation for herbs, patients are generally not able to know how much of the herb is present or what portion of the herb is contained within any given product. Concerns about herbal products are reported both in the scientific literature and the media. Manufacturers of herbal supplements are responsible for making sure the claims they make about their products are not false or misleading, and for backing them up with sufficient evidence. Manufacturers may make claims about structure and function, provided that they include a disclaimer that their products have not been reviewed by FDA and are not intended for medical use. Some manufacturers may use the term standardized on the supplement label, but this does not necessarily mean the same thing from manufacturer to manufacturer.
An easy way to compare ingredients on products is by using the dietary supplements label database, available from the website for the US National Institutes of Health. Verification and certification programs for dietary supplements and food additive ingredients can be used by manufacturers to help ensure that the quality of their products is up-to-date. By becoming aware of resources and tools that can assist in the identification of high-quality dietary supplements for example, meeting government standards and using verification programs doctors can assist their patients in selecting the right products. Dietary supplements have stricter manufacturing and quality-control regulations to comply with than foods, and must thus be manufactured at CGMP-compliant manufacturing facilities approved to manufacture dietary supplements.
Dietary supplements that fail to meet specifications required under the CGMP regulations are considered violative; however, the FDA generally may make this determination only after a product is placed on the market, and products in the dietary supplement market are not regularly tested by the FDA to determine if product specifications are met. These include the requirement to notify before marketing for some novel dietary ingredients, but FDA reviews of such notifications are not comparable to the drug preapproval process. Furthermore, in contrast to the framework for drugs, compliance with a United States Pharmacopeia-National Formulary (USP-NF) government-wide quality standards is voluntary for all dietary supplements. FDA maintains a list of supplements under regulatory review or reported to cause adverse effects.
Testing for illicit use of drugs is not medical testing under the ADA, nor is it subject to restrictions on that testing. A drug illegal use testing is not considered to be a medical examination under the ADA; thus, employers can perform such tests for applicants or employees and make hiring decisions on the basis of the results. Pre-employment inquiries into disabilities may be required by those laws in order to identify applicants or customers with disabilities to ensure that they are provided with necessary specialized services.
For OTC medications, they do not have to be expired prior to use by an eligible patient, according to directions for use in manufacturers labels. For prescription drugs, they must not expire before the completion of the drug by the eligible patient based on the directions from a prescriber.
If using herbal supplements, carefully follow the labels directions and only use prescribed dosages. Your health care provider or pharmacist may also be able to verify that any supplements you take do not dangerously interact with your medications.
For instance, taking a combination of herbal supplements, or using supplements along with your prescription medications, could result in harmful, even life-threatening, results. Herbal products may present an unexpected risk since many supplements contain active ingredients that exert powerful effects on the body. However, herbs and botanical products – including products labelled natural – may have powerful effects on the body.
Many prescription drugs and over-the-counter medications are also made with plant products, but those products only have refined ingredients and are regulated by the FDA. Products made from botanicals, or plants, used for treating diseases or for maintaining health are called herbal products, botanical products, or plant-based medicines.
All owners of herbal medicine businesses are capable of creating value-added products, such as herbs pillows and gift sets. The best way to promote a medicinal herbs business selling directly to individuals is by providing information on medicinal herbs benefits. You can choose to do this online, via articles and websites, or in-person, giving talks and hosting classes about medicinal herbs. While it is completely legitimate to make your own tinctures, tea blends, and salves to share with friends and family, you need to comply with regulations in order to sell your herbal products or plant-based medicines in retail settings or online. Depending on where you live, that can include your own home (most states do not permit the manufacture of food additives in your home), a shared-use commercial kitchen space (a rental space for small businesses), your own manufacturing space, or the restaurant or other eating establishment in which you are employed. Herbal products may be labeled as organic only when the whole product (or at least 95% of the ingredients) has been certified as organic under the National Organic Program (NOP).