Manufacturing and Marketing Cosmeceutical* and Homeopathic OTCs: Complying with FDA's Rules for Drug Products that do not require FDA Pre-Approval: One and a half day In-person Seminar
Bill Schwemer, Principal, Schwemer Consulting, Former Senior official with FDA's Office of the Commissioner
South Beach, FL
| Thursday, November 13, 2014 | Friday, November 14, 2014
This interactive one and a half day seminar is intended to help companies understand the legal definitions of cosmetics, drugs, dietary supplements and why products of similar composition may be defined differently by their labeling and thus have to meet different regulatory requirements. It will also explain differences in the way homeopathic and conventional drugs are regulated.
It will address such issues as:
- How the intended use of the product owner defines a product
- Can a drug contain both allopathic and homeopathic ingredients
- Information that must appear on the principal display panel
- Type size requirements for label text
- Understanding OTC Drug Monographs
- Elements of "drug facts" boxed labeling
- How to label a product that has both OTC drug and cosmetic claims
- Basic requirements for marketing Homeopathic OTC drugs
- GMP requirements for cosmeceuticals that can be met at lower cost
Seminar instructor Bill Schwemer is an ex-FDA official having more than 50 years of experience in dealing with FDA compliance matters that include 30 years he spent working with the FDA as a field Investigator, Director of Field Investigations, Assistant Associate Commissioner for Regulatory Affairs and Special Assistant to Deputy Commissioner for Policy.
While certain discussions will be applicable to solid dose form and other higher risk ingestible OTC drugs, including items recently switched from Rx to OTC, this program is intended primarily to address topical liquid, suspension, ointment, powder, and emulsion products that have no dosage limitations.
- Understand FDA rules and policies regarding manufacturing and labeling of low risk OTC drugs not covered by approved New Drug Applications.
- Learn the definitions of drug, cosmetic, dietary supplement.
- Understand how labeling other than labels and advertising can define a product and cause it to be misbranded or considered a new drug.
- Differentiate cosmetic “puffery" claims from claims that FDA would likely consider drug claims.
- Understand the differences between allopathic (conventional) drugs and homeopathic 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:
- Personal Care Products companies that need to better understand current manufacturing & labeling regulations
- Cosmetics, nutritional, liquid soap or other companies making drug claims for products
- Consumer products companies considering expanding their product lines
- Own Label distributors of cosmeceuticals and/or homeopathic products that do not have a regulatory professional on staff
- Senior managers / business owners
- Product managers
- Labeling & Artwork designers
- Regulatory and Quality professionals
- Sales and marketing managers
- Customer service professionals
- R & D Managers or staff
- Product formulation engineers
- Manufacturing professionals
A company may begin to manufacture products covered during this seminar without any consultation with the FDA or the agency's approval. If its products are drugs, drug registration and listing forms shall be submitted to the FDA when marketing begins. The products to be discussed in this seminar are generally relatively safe formulations and many could be marketed as cosmetics for which there are no FDA GMP regulations. However, depending on its intended use, a product's formula and labeling may need to conform to an OTC Drug Monograph and its manufacturing performed in conformance with FDA's good manufacturing practices (GMPs) regulations for drugs. The cost of implementing adequate GMPs can be lower for low risk OTC drug products than for higher risk drugs and some of the GMP requirements are not even applicable to making Homeopathic drugs.
*The FDA does not officially recognize the term "cosmeceuticals"; however, many people use it when referring to personal care products which FDA officially calls "Cosmetics which are also drugs."
|Day One (8:30 AM - 5:00 PM)
||Day Two (8:30 AM - 1:00 PM)
Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM
- 9:00 AM - 9:15 AM: Introduction
- 9:15 - 10:15 AM: Overview of Law & Regulations for Drug Products
- 10:15 - 10:30 AM: Break
- 10.30 - 11:15 AM: Labeling Idiosyncrasies - Cosmetics, Drugs, Dietary Supplements
- 11:15 - 12:15 PM: OTC Monographs - Focus on Topical Products
- 12:15 - 1:15 PM: Lunch
- 1:15 - 2:15 PM: Cosmeceuticals - Cosmetics that are also Drugs
- 2:15 - 3:15 PM: FDA Policy Regarding Marketing Homeopathic Drugs
- 3:15 - 3:30 PM: Break
- 3:30 - 4:30 PM: OTC Drug Facts Labeling
- 4:30 - 5:00 PM: Q & A
- 8:30 - 10:00 AM: Complying with Finished Drug CGMPs (for Low Risk Products)
- 10:00 - 10:30 AM: Break
- 10:30 - 11:00 AM: FDA Guidance: Contract Manufacturing of Drugs
- 11:00 - 11:30 AM: Reporting Serious Advents to FDA
- 11:30 - 12:30 PM: Workshop - Groups review scenarios and report findings
- 12:30 - 1:00 PM: Q&A, Hand out Certificates & Close
Meet Your Instructor
Principal, Schwemer Consulting and former Senior FDA & Industry Official
Bill Schwemer is an ex-FDA official having more than 50 years’ experience with FDA compliance matters. He has worked as an FDA field Investigator and Compliance Officer, been a senior official with FDA's Office of the Commissioner and was V-P of RA/QA at a Personal Care Products Company. Mr. Schwemer worked in all program areas, but has consulted primarily with 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 20 lawsuits.
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South Beach, FL (Venue to be announced shortly)
November 13-14, 2014
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