Herbal Dietary Supplements
In the United States, the FDA regulates both final products and ingredients in food additives, pursuant to the Dietary Supplement Health and Education Act (DSHEA) of 1994. Under that act, manufacturers of dietary supplements do not need FDA approval before they manufacture, label, distribute, and market their products.
Unfortunately, a 1994 law known as the Dietary Supplement Health and Education Act [DSHEA] makes it very difficult for the FDA to take action and to offer meaningful protections against unsafe products. The 1994 Dietary Supplement Health and Education Act (DSHEA) amended federal food regulations, in part, by defining dietary supplements, adding specific labeling requirements for dietary supplements, and providing for the option to include a statement on labeling. FDA regulated nutritional supplements as a component of the Dietary Supplement Health and Education Act of 1994, but because of substantial gaps in DSHEA, the Agency was not able to protect the publics health efficiently or effectively. Accordingly, FDA mainly regulates dietary supplement safety by postmarket assessment whether products are adulterated or misbranded, in accordance with provisions in Food.
A dietary supplement manufacturer making a statement of claim shall have evidence to show that the statement is true, is not misguided, and shall inform The Food and Drug Administration of its products having such claim within 30 days after marketing products that make the statement. For supplements that do not contain the newest dietary ingredients, i.e., the dietary ingredients not sold to the Government prior to Oct. 15, 1994, manufacturers are not required to submit proof to The Food and Drug Administration about a products safety either before or after marketing. With the exception of products manufactured at private homes, all production facilities are required to be registered with FDA as part of the bioterrorism law, but, unlike most state registration or licensure processes, it does not require the product to have labeling submitted. While the DSHEA does require manufacturers to label their products as supplements and provide a complete ingredient list, manufacturers are not required to notify FDA about adverse events reports that they might receive from consumers.
They only apply to supplements that contain vitamins and/or minerals, provided those products are regulated as foods, and they cover supplement ingredients, including safety, purity, and bioavailability. Based on the EFSAs work, the European Commission reviews and updates the permitted list. For all substances added to food, including food additives, which are claimed to affect consumers nutrient or health status, EFSA conducts assessment under Regulation (EC) No 1924/2006 on claims about diet and health. Non-food additives (herbs and plant substances, metabolites) are not foods, but can be regulated as medicines.
In Australia, most food additives are regulated under the complementary medicines category, including vitamins, minerals, herbs, aromatherapy, and homeopathic products, though some products may be considered specialty products and regulated under the Food Authority. Regulations cover product registration and/or business licences required for distribution of animal feeds within the various states, ingredients used in the products, production of food, and food labelling (including labels and other materials, such as leaflets). On September 23, 1997 (62 FR 49826), FDA implemented the DSHSEA, issuing several landmark regulations regarding statement of identity, nutrition labeling, ingredients labels, and nutrition content and health claims for food additives.
Because the dietary supplement industry takes consumer safety seriously, we called upon Congress in 2006 to pass new consumer reporting requirements for severe adverse events, and we supported Congresss addition in 2011 to business registrations and authorities to the FDA and to medicines to force the recall of adulterated products. The U.S. dietary supplement industry has grown from approximately 4,000 products in 1994 to an estimated 50,0000 to 80,000 products as of FY2021, and about 80 percent of U.S. adults reported taking dietary supplements, according to a Consumer Reports 2021 Consumer Survey.2 These increases in the number of products and consumer use highlight the importance of physicians understanding of potential quality concerns with products presented as dietary supplements, given the U.S. Food and Drug Administrations regulation of supplements to enforce recalls. The Food and Drug Administration regulates quality, safety, and labeling of dietary supplements, and the Federal Trade Commission controls advertising and marketing; however, there are still substantial enforcement challenges, and optimum governmental oversight has not been achieved. Under U.S. law, a food additive is considered a violation if it is represented (e.g., in the products labeling) as meeting the standards found in USP-NF, but fails to do so.5 This situation may provide an incentive for manufacturers to make claims about the conformity of their food ingredients or supplements to public-quality standards, such as those found in USP-NF, since if a product does not, in fact, conform to a public-quality standard, the products may be considered a false brand. Compositions of the present invention can comprise one type or more than one type of Ramulus Sambuci Williamsii composition. For example, dietary supplements can comprise Ramulus Sambuci Williamsii powder and Ramulus Sambuci Williamsii extract. Additionally, compositions can comprise the Fructus Rosae component in any amount. For example, dietary supplements can comprise a Ramulus Sambuci Williamsii composition in at least about 1% (such as at least about 2%, 3%, 4%, 5%, 10%, 5%, 10%, 15%, 30%, 40%, 50%, 60%, 70%, 80%, or 90%). Generally, compositions comprise a Ramulus Sambuci Williamsii composition of about 400 mg to about 4,000 mg.