Mememe Posted July 14, 2011 Report Share Posted July 14, 2011 (edited) MM is a nutritional supplement! Was looking through FDA guidelines for dietary supplements and found some interesting reading. 1. White House commission on complementary and alternative medicine policy CAM:) http://www.whccamp.hhs.gov/fr2.html Complementary and alternative medicine, or CAM, can be defined as a group of medical, health care, and healing systems other than those included in mainstream health care in the United States. CAM includes the worldviews, theories, modalities, products, and practices associated with these systems and their use to treat illness and promote health and well-being. Although heterogeneous, the major CAM systems have many common characteristics, including a focus on individualizing treatments, treating the whole person, promoting self-care and self-healing, and recognizing the spiritual nature of each individual. In addition, many CAM systems have characteristics commonly found in mainstream health care, such as a focus on good nutrition and preventive practices. Unlike mainstream medicine, CAM often lacks or has only limited experimental and clinical study; however, scientific investigation of CAM is beginning to address this knowledge gap. Thus, boundaries between CAM and mainstream medicine, as well as among different CAM systems, are often blurred and are constantly changing. CAM and Chronic Pain A recent national survey by Astin17 found that back problems were the most common medical condition (24 percent) for which people reported using CAM treatments. In this survey, neck problems also were associated with frequent use of CAM. Other studies have found that one-third of all patients suffering from back pain choose chiropractors over physicians to treat them, and that chiropractors provided 40 percent of primary care for back pain.41,42 Moreover, these studies found that chiropractors retained a greater proportion of their patients (92 percent) for subsequent episodes of back pain care than did other providers. Similarly, Krauss and colleagues43 found that CAM practitioners and products were chosen more often than conventional physicians and therapies by those persons with chronic pain (52 versus 34 percent) and headaches (51 versus 19 percent ), as well as by persons suffering from other associated maladies, including depression (34 versus 25 percent), anxiety (42 versus 13 percent), and insomnia (32 versus 16 percent). 2. http://www.fda.gov/Food/DietarySupplements/ucm109764.htm The Federal Food, Drug, and Cosmetic Act (the act) requires that manufacturers and distributors who wish to market dietary supplements that contain "new dietary ingredients" notify the Food and Drug Administration about these ingredients. (See Section 413b of the act (21 U.S.C. 350b).) Generally, the notification must include information that is the basis on which manufacturers/distributors have concluded that a dietary supplement containing a new dietary ingredient will reasonably be expected to be safe under the conditions of use recommended or suggested in the labeling. The term "new dietary ingredient" means a dietary ingredient that was not marketed in the United States in a dietary supplement before October 15, 1994. (See section 413© of the Federal Food, Drug, and Cosmetic Act (the act), 21 U.S.C. 350b©). There is no authoritative list of dietary ingredients that were marketed in dietary supplements before October 15, 1994. Therefore, manufacturers and distributors (you) are responsible for determining if an ingredient is a "new dietary ingredient" and, if not, for documenting that a dietary supplement that contained the dietary ingredient was marketed before October 15, 1994. If you want to market a "new dietary ingredient" in a dietary supplement, you must be sure that the substance is considered to be a "dietary ingredient." (See section 201(ff)(1) of the act (21 U.S.C 321(ff)(1)). A dietary ingredient is a vitamin; a mineral; an herb or other botanical; an amino acid; a dietary substance for use by man to supplement the diet by increasing total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of any of the above dietary ingredients. In addition, the product containing the dietary ingredient must be a dietary supplement. (See section 201(ff) of the act (21 U.S.C. 321 (ff)). The term "dietary supplement" means a product (other than tobacco) intended to supplement the diet that contains one or more dietary ingredients. A dietary supplement is limited to products that are intended for ingestion in tablet, capsule, powder, softgel, gelcap, and liquid form, that are not represented as conventional food or as the sole item of a meal or of the diet, and that are labeled as dietary supplements. Additionally, dietary supplements do not include products that are approved drugs, certified antibiotics, or licensed biologics. Dietary supplements also do not include products that are authorized for investigation as a new drug, antibiotic, or biologic (and for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public), unless the product was marketed as a dietary supplement or as a food before it was approved as a drug, antibiotic, or biologic, or, in the case of investigational products, before the public disclosure of such investigations. The act provides that a dietary supplement that contains a new dietary ingredient shall be deemed adulterated under section 402(f) of the act (21 U.S.C. 342(f)) unless it meets one of two requirements: 1. The dietary supplement contains only dietary ingredients which have been present in the food supply as an article used for food in a form in which the food has not been chemically altered; or 2. There is a history of use or other evidence of safety establishing that the dietary ingredient when used under the conditions recommended or suggested in the labeling of the dietary supplement will reasonably be expected to be safe and, at least 75 days before being introduced or delivered for introduction into interstate commerce, the manufacturer or distributor of the dietary ingredient or dietary supplement provides the FDA with information, including any citation to published articles, which is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe. (See Section 413 of the act (21 U.S.C. 350b2) and section 402(f) of the act (21 U.S.C. 342(f)3). In other words, if the dietary ingredient has not been present in the food supply as an article used for food, you must show why you consider that the consumption of a new dietary ingredient is reasonably expected to be safe under the conditions recommended or suggested in the labeling. What information must the notification contain? If you plan to market a dietary supplement that contains a new dietary ingredient, you must submit to FDA, at least 75 days before the dietary ingredient is introduced or delivered for introduction into interstate commerce, information that is the basis on which you have concluded that a dietary supplement containing the new dietary ingredient will reasonably be expected to be safe. FDA regulations require that you submit an original and two (2) copies of the notification and all of its attachments. You must also provide in the notification: * Your name and complete address. * The name of the new dietary ingredient. If the new dietary ingredient is an herb or other botanical, you must include the Latin binomial name (including the author). * A description of the dietary supplement or dietary supplements that contain the new dietary ingredient, including the: o level of the new dietary ingredient in the product; o conditions of use of the product stated in the labeling or if no conditions of use are stated, the ordinary conditions of use; and o history of use or other evidence of safety establishing that the dietary ingredient, when used under the conditions recommended or suggested in the labeling of the dietary supplement, will be reasonably be expected to be safe. + Any reference to published materials must be accompanied by reprints or photostatic copies. + Any material in a foreign language must be accompanied by a translation. * A signature by a person designated by you who can be contacted if we have questions. http://www.fda.gov/Food/DietarySupplements/ucm109764.htm Edited July 14, 2011 by Mememe Quote Link to comment Share on other sites More sharing options...
Join the conversation
You can post now and register later. If you have an account, sign in now to post with your account.