Course Description:
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 鈥榠ntended use鈥� 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.
Note: Use coupon code 232082 and get 10% off on registration.
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 鈥榠ntended use鈥� 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.
Note: Use coupon code 232082 and get 10% off on registration.
