Dietary and herbal supplement companies are themselves responsible for evaluating the safety and labeling of their products prior to marketing, in order to make sure that they are compliant with all requirements of the Dietary Supplement Health and Education Act. Herbal supplements are not subject to the same standards of testing, manufacture, and labeling regulations that drugs are. This is because herbal supplements are not subject to clinical trials, nor are they subject to the same manufacturing standards as prescribed or mainstream OTC medications. Herbal supplements, unlike medications, are not required to be standardized in order to provide batch-to-batch consistency.
Many prescription drugs and over-the-counter medications are also made with botanical 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. Some herbal products can be beneficial in the sports context; however, the U.S. Food and Drug Administrations (FDA) current regulations do not guarantee the safety and efficacy of products.
Compounding this rise in accessibility and usage are governmental regulations limiting the Food and Drug Administrations (FDA) ability to regulate any product labelled as a supplement. Dietary supplements and their sometimes questionable claims about their health effects are regulated by the FDA in a way different from regular foods or medicines. 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 health conditions.
Determining the safety and efficacy 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 therapies. Because of limited regulation of 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. Both the scientific literature and the media report concerns about herbal products. Variability in these active ingredients is worrisome, as the more pervasive risks for using herbal products are toxicities and adverse reactions, herbal-drug interactions, and herbal adulteration.
Manufacturers may utilize these documentary standards for verifying the identity of ingredients used in dietary supplements. 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. For example, manufacturers and distributors that want to sell food additives containing newdietary ingredients (i.e., food ingredients not sold in the U.S. as food additives prior to Oct. 15, 1994) must typically inform the FDA about those ingredients (see Section 413(d) of the federal food code.
When a substance is excluded from the definition of dietary supplements in section 201(ff)(3)(B) of the FD&C Act, the exclusion applies unless FDA, in its discretion, has issued a rule, after notice and comment, finding that such an item would be legal under the FD&C Act. Section 330; (b) With respect to any specific individual, any substance for which there is a research use exemption under SS 505 of the Federal Food, Drug, and Cosmetic Act, the exemption so long as the conduct involving such substance is conducted under that exemption; or (c) any substance, so long as it is not intended for human consumption prior to enactment of that exemption; or (c) any substance, so long as it is conducted with respect to that substance pursuant to that exemption, under section 330; (a) with respect to any substance, for any person, an exemption to which a waiver is effective for such exemption for such exemption for such individual pursuant to that individual pursuant to that individual pursuant to that individual pursuant to such exemption for that individual under FD &C on such exemption, so long as no such waiver is applicable, for that person, under FD &C on such exemption, so long as no such waiver is intended for human consumption; or (d) an exception for that person, prior to enactment under that exemption.
Marijuana shall not include (i) industrial hemp, as defined in SS 54.1-2901, that is possessed by a person registered pursuant to subsection A of SS 3.2-4115 or his agent, or (ii) hemp product, as defined in SS 3.2-4112, containing a concentration of tetrahydrocannabinol not greater than 0.3 percent, that is derived from industrial hemp, as defined in SS 3.2-4112, that is grown, sold, or processed in accordance with state or federal law. Nothing contained herein shall be deemed to change the negligence statutes when applied to acts by any agent or agent or provider under a power of attorney, and nothing contained herein shall be construed to set forth a tetrahydrocannabinol, that is grown, traded, or processed, pursuant to the definition of SS 3.2-4112, derived from industrial hemp, derived, as defined in SS 3.2-4112, grown, traded, or processed pursuant to the provisions of this Act, or processed in accordance with the provisions of the statute. Nothing contained in this Act will be deemed to change the law of negligence when applied to the law of negligence, nor anything in this Act will be deemed to set the standard of care of a medical power of attorney, or provider.
Some manufacturers may use the term “standardized” on the supplement label, but this does not necessarily mean the same thing from manufacturer to manufacturer. Kava kava is frequently included in herbal, multi-component sleeping remedies, so it is important to read labels carefully. St. Johns Wort needs to be used cautiously, and physicians need to familiarize themselves with the specific interactions and exercise caution any time someone may take it concomitantly with medications.
If using herbal supplements, carefully follow the labels directions and only use prescribed dosages. If you are thinking of using a plant-based medication, first obtain information on it from reliable sources.
The U.S. Pharmacopeia DSC also includes General Chapters related to Good Manufacturing Practices that manufacturers can use to help make sure that their supplements are made using safe, sanitary, well-controlled production practices. As an organizing body of standards dedicated to the advancement of public health, USP supports manufacturers of food additives in continuing their efforts to produce quality products to meet the needs of consumers. FDA continues to support robust, science-based research on the medical uses of pharmacological products that contain cannabis or hemp-derived compounds, and will continue to collaborate with companies that are interested in bringing safe, effective, quality products to the marketplace. FDA is aware that certain companies are marketing products containing cannabis and cannabis-derived compounds in ways that are inconsistent with the federal Food, Drug, and Cosmetic Act (FD&C Act) and may endanger the health and safety of consumers. Such products can be sold lawfully in human foods for the uses described in the Notice, provided that they meet all other requirements.