This interactive one and a half day seminar is intended to help companies understand the legal definitions of cosmetics, drugs, dietary supplements and why certain labeling statements for non-drug products may cause the agency to consider them new drugs without FDA approval.
The instructor, a leading industry expert and former FDA official, will explain differences in the way homeopathic and conventional drugs are regulated and how the risks presented by different types of drug products affect the rigor of FDA enforcement of Good Manufacturing Practices Regulations. A workshop will be held at the finale of the course to emphasize certain issues by having participants review labels of misbranded products and examples of recent FDA Warning Letters.
The seminar will address issues such as:
- How both labeling and advertising establishes ‘intended use’ which defines a product?
- When cosmetics, dietary supplements and foods might become drugs requiring FDA approval?
- How OTC drug monographs can help one to formulate products and design labels?
- Why are OTC drug/cosmetic combinations (cosmeceuticals) allowed, but not OTC drug/dietary supplement combinations?
- What are common personal care product ingredients that have both cosmetic and drug uses?
- The restriction on combining allopathic and homeopathic ingredients in a drug formula.
- Things that one needs to know when designing labels:
- Creative product names can cause a product to be misbranded.
- Proper formatting of Drug Facts boxed panels.
- Type size requirements and placement of information on principal display panels.
- Changes FDA now believes may be needed in monograph content and in changing monographs.
- Understand FDA regulations and policies regarding manufacturing and labeling of OTC drugs covered by OTC drug monographs (minimal information is provided to contrast the new drug approval process).
- Learn the definitions of drug, cosmetic, and dietary supplements.
- Obtain tips on how to research FDA’s OTC drug monograph rulemakings.
- What labeling other than labels can define a product and cause it to be misbranded as a new drug.
- Learn that certain ingredients are safe and suitable for use in both drugs and cosmetics.
- Differentiate cosmetic ‘puffery’ claims from claims that FDA would likely consider drug claims.
- Learn how to formulate and label cosmeceuticals (cosmetics which are also drugs).
- Understand the differences in how allopathic (conventional) drugs and homeopathic drugs are regulated.
- Learn the basic requirements for marketing homeopathic OTC drugs.
- Recognize ways to manufacture low health risk products at minimum cost, yet still meet the intent and basic requirements of GMP regulations.
- Learn how to minimize the regulatory risk of a Warning Letter or other FDA action.
Who Will Benefit:
This course is intended for personal care product manufacturers and other businesses that wish to develop and/or market drugs that do not require FDA approval. It will also benefit cosmetic, nutritional, liquid soap and other companies that are considering health related claims for their products, but wish to avoid labeling that would make them new drugs lacking FDA approval. While the emphasis is on topical OTCs, well over half of the presentations are also applicable to OTCs taken internally. It will especially benefit own label distributors and smaller firms that do not have a regulatory professional on their staff. This includes:
- Senior Managers / Business Owners
- Product Managers
- Labeling and Artwork Designers
- Regulatory and Quality Professionals
- Sales and Marketing Managers
- R&D Managers and Staff
A company may begin to manufacture OTC drug products without any consultation with the FDA or the agency's approval. However, drug registration and listing forms shall be submitted to the FDA when marketing begins. The allopathic or conventional drug products, including cosmeceuticals, need to conform to an OTC drug monograph. Monographs are not established for homeopathic drugs; however, both allopathic and homeopathic drugs need to be manufactured in conformance with FDA's Good Manufacturing Practices (GMPs) regulations. A few GMP requirements are not required for homeopathic drugs and generally the rigor and therefore the cost of implementing adequate GMPs for low risk OTC drug products can be less.
Meet Your Instructor
Principal, Schwemer Consulting and Former Senior FDA & Industry Official
Bill Schwemer is an ex-FDA official with more than 50 years’ experience in FDA compliance matters. He was an FDA field investigator and compliance officer in two districts. As director, division of field investigations, he managed the FDA foreign inspection program and his staff supported the district investigations branches. He was a senior official in FDA's Office of the Commissioner in both the Offices of Regulatory Affairs and Policy. His industry experience includes V-P of RA/QA at a personal care products company and consulting for businesses nationwide and in Europe and Asia. His consulting business in recent years has been primarily for pharmaceutical and personal care products companies. He has published more than 125 articles and since becoming a consultant has successfully served as a regulatory compliance expert witness in 22 lawsuits.
In his FDA Office of Regulatory Affairs positions, Mr. Schwemer had insights on all current OTC Drug Compliance Policy Guides (CPGs) and approved either original drafts or revisions on behalf of the office. Recently, he petitioned FDA to revise the CPG “Conditions Under Which Homeopathic Drugs May be Marketed.”
Note: Use coupon code NB5SQH8N and get 10% off on registration.
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When & Where
Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.