Dietary Supplements' CGMPs, 21 CFR 111

Description:

This webinar will consider the FDA's mandate by law on dietary supplements. They are regulated by the FDA as food, not as drugs. However, many dietary supplements contain ingredients that have strong biological effects which may conflict with a medicine you are taking or a medical condition you may have. Products containing hidden drugs are also sometimes falsely marketed as dietary supplements, putting consumers at even greater risk. Dietary supplements are intended to add to or supplement the diet and are different from conventional food. Generally, to the extent a product is intended to treat, diagnose, cure, or prevent diseases, it is a drug, even if it is labeled as a dietary supplement. Supplements are ingested and come in many forms.

The Federal Food, Drug, and Cosmetic Act (FD&C Act) was amended in 1994 by the Dietary Supplement Health and Education Act (DSHEA), which defined “dietary supplement” and set out FDA’s authority. The FDA does not have the authority to approve dietary supplements for safety and effectiveness, or to approve their labeling, before the supplements are sold to the public. It is the responsibility of dietary supplement companies to ensure their products meet the safety standards for dietary supplements and are not otherwise in violation of the law. Dietary supplement labels are required to have nutrition information in the form of a Supplement Facts label. They also must have a statement on the. front of the product identifying it as a “dietary supplement” or similar. Even if a product is labeled as a dietary supplement, a product intended to treat, prevent, cure, or alleviate the symptoms of a disease is a drug, subject to all requirements that apply to drugs.

Why Should You Attend:

FDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded. That means that these firms are responsible for manufacturing them under the CGMPs for dietary supplements, 21 CFR 111. They are also responsible for evaluating the safety and labeling of their products before marketing, to ensure that they meet all the requirements of the Federal Food, Drug, and Cosmetic Act as amended by DSHEA and FDA regulations. FDA has the authority to take action against any adulterated or misbranded dietary supplement product after it reaches the market.

Areas Covered in the Webinar:

• What is a dietary supplement under law
• Dietary Supplements' CGMPs, 21 CFR 111
• How implemented? Major areas of concern
• Specific labeling requirements
• Industry problem areas
• FDA's "reactive" role and how implemented
• Adverse Events reporting

Who Will Benefit:

• Senior management
• Regulatory Affairs
• Quality Assurance
• Production
• R&D and Engineering

All personnel involved in the U.S. FDA-regulated dietary supplements industry (CGMPS). Especially those involved in new supplement product development, line extensions, and incremental product improvements.

John E Lincoln
Principal, J E Lincoln and Associates

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 42 years experience in U.S. FDA-regulated industries, 27 of which are as an independent consultant. John has worked with global companies to resolve regulatory issues, lead validations (hardware and software) and implement QMS/RA systems. He has published numerous articles in peer reviewed journals, 5 chapters in the RAPS textbook on Validation, conducted workshops and webinars worldwide. John is a graduate of UCLA.

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