![]() The requirements in this section apply to the label or labeling of dietary supplements where the dietary supplement bears a statement that is provided for by section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act (the act), and the manufacturer, packer, or distributor wishes to take advantage of the exemption to section 201(g)(1)(C) of the act that is provided by compliance with section 403(r)(6) of the act. The individual shall certify that the information contained in the notice is complete and accurate, and that the notifying firm has substantiation that the statement is truthful and not misleading. (3) The notice shall be signed by a responsible individual or the person who can certify the accuracy of the information presented and contained in the notice. (iv) The name of the dietary supplement (including brand name), if not provided in response to paragraph (a)(2)(iii) on whose label, or in whose labeling, the statement appears. (iii) The name of the dietary ingredient or supplement that is the subject of the statement, if not provided in the text of the statement and (ii) The text of the statement that is being made (i) The name and address of the manufacturer, packer, or distributor of the dietary supplement that bears the statement (2) The notification shall include the following: An original and two copies of this notification shall be submitted. (a)(1) No later than 30 days after the first marketing of a dietary supplement that bears one of the statements listed in section 403(r)(6) or the Federal Food, Drug, and Cosmetic Act, the manufacturer, packer, or distributor of the dietary supplement shall notify the Office of Nutritional Products, Labeling and Dietary Supplements (HFS-810), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, that it has included such a statement on the label or in the labeling of its product. 101.93 Certain types of statements for dietary supplements. Subpart F - Specific Requirements for Descriptive Claims That Are Neither Nutrient Content Claims nor Health Claims SUBCHAPTER B - FOOD FOR HUMAN CONSUMPTION Learn how to talk about mental health or how to get help for yourself or someone you care about.The information on this page is current as of Jan 17, 2023.įor the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). Learn more about the importance of prevention and wellness. Getting professional help if you need it.Ways to maintain positive mental health include: Make meaningful contributions to their communities.Learn more about specific mental health problems and where to find help. Inability to perform daily tasks like taking care of your kids or getting to work or school.Hearing voices or believing things that are not true.Having persistent thoughts and memories you can't get out of your head.Experiencing severe mood swings that cause problems in relationships.Yelling or fighting with family and friends.Feeling unusually confused, forgetful, on edge, angry, upset, worried, or scared.Smoking, drinking, or using drugs more than usual.Pulling away from people and usual activities.Eating or sleeping too much or too little.Not sure if you or someone you know is living with mental health problems? Experiencing one or more of the following feelings or behaviors can be an early warning sign of a problem: People with mental health problems can get better and many recover completely. Mental health problems are common but help is available. Family history of mental health problems.Life experiences, such as trauma or abuse.Biological factors, such as genes or brain chemistry.Many factors contribute to mental health problems, including: Over the course of your life, if you experience mental health problems, your thinking, mood, and behavior could be affected. Mental health is important at every stage of life, from childhood and adolescence through adulthood. It also helps determine how we handle stress, relate to others, and make choices. ![]() Mental health includes our emotional, psychological, and social well-being.
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