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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
Location :-
Courtyard Jersey City Newport, NJ
| Thursday, April 24, 2014 | Friday, April 25, 2014

Course "Manufacturing and Marketing Cosmeceutical* and Homeopathic OTCs: Complying with FDA's Rules for Drug Products that do not require FDA Pre-Approval" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

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 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.

Learning Objectives:

  • 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:

Company Types Titles
  • 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

Topic Background:

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."

Course Outline:

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

Bill Schwemer
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.

Register Online


Seminar One Registration

April 24-25,2014, Jersey City, NJ

You Save: $1,995.00(22%)*

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April 24-25,2014, Jersey City, NJ
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Price $1,499

The registration fee includes: the workshop; all related course materials; morning tea/coffee on both the days, lunch and afternoon tea/coffee on day one.

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Special Offer for the attendees of this seminar:

Rooms available at only $249 per night.

Please note: Hotel rooms are limited and based on availability

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How to Reach

General Driving Directions:

Driving Directions from Newark Liberty International Airport – EWR: 11 mile(s) NE
  • Take New Jersey Turnpike North towards New York City.
  • Take Exit 14C towards the Holland Tunnel.
  • After paying the toll at 14C continue toward the Holland Tunnel.
  • Turn right on Jersey Avenue (first light).
  • Immediately bear left toward the Newport Centre Mall and continue to Washington Boulevard (first stop light) and turn right. Hotel is on the left.

Driving Directions from LaGuardia Airport – LGA: 13 mile(s) SW
  • Take Grand Central Parkway until Exit 4, the Brooklyn/Queens Expressway then merge with I-278 West until Exit 32A.
  • Merge onto Williamsburg Bridge and continue to Delancey Street and make a slight right.
  • Turn left onto Christie Street, then right onto Canal Street.
  • Make a right onto Hudson Street and take the Holland Tunnel.
  • After the Tunnel, turn left on Marin Blvd and follow until 6th Street, turn left.
  • Turn left again on Washington Blvd. The hotel will be on your right.

Driving Directions from John F Kennedy International Airport – JFK: 21 mile(s) NW
  • Take Van Wyck Expressway to I-678 North and follow to Exit 12B, I-495 West.
  • Take I-495 until Exit 17W and merge onto the Queens Midtown Expressway.
  • Follow signs for I-278 West (towards Brooklyn) until Exit 32A.
  • Merge onto Williamsburg Bridge and continue to Delancey Street and make a slight right.
  • Turn left onto Christie Street, then right onto Canal Street.
  • Make a right onto Hudson Street and take the Holland Tunnel.
  • After the Tunnel, turn left on Marin Blvd and follow until 6th Street, turn left.
  • Turn left again on Washington Blvd. The hotel will be on your right.

Other Transportation:

Bus Station
  • Hoboken: 1.5 mile(s) N

Subway Station
  • NJPATH /Pavonia-Newport: 0.4 mile(s) SW

Train Station
  • Hoboken: 1.5 mile(s) N

Disclaimer: Directions to the venue above have been taken from the hotel website. Attendees are advised to check with the hotel for confirmation of these directions before starting for the venue. ComplianceOnline is not responsible for any inaccuracies in the same.

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Local Attractions

Liberty State Park is a green oasis, over 1,212 acres in the middle of Jersey City with spectacular views of the Manhattan skyline, the Statue of Liberty and Ellis Island, making it one of the state's most dramatic parks. Liberty State Park is the perfect place for a family and picnic at one of the playgrounds.

Experience the nation's Gateway to freedom, with a visit to Ellis Island and the Statue of Liberty, two living examples of America's commitment to freedom. After undergoing a massive $162 million restoration, Ellis Island today offers visitors an array of programs including a genealogy workshop, theatrical productions based on actual immigrant accounts, a learning center, a museum and a new family history research facility.

Liberty National Golf Club is a country club in Jersey City, New Jersey with a 7,346 yard course designed by Robert E. Cupp and Tom Kite. The club cost over $250 million to build, making it one of the most expensive golf courses in history. Club designers added amenities such as an on-site heliport, yacht services, a spa and a restaurant.

Jersey City Museum is an art museum located in the Van Vorst Park section of Downtown Jersey City, New Jersey. Serving a diverse community, the Museum collects, exhibits, preserves, and interprets its collections of 19th- and 20th-century paintings, works on paper, sculpture, and material culture from the region.

Established in 1924, this octagonal clock is one of Jersey City's landmarks, inspired from Colgate's Octagon Soap. The clock has a surface of 1,963.5 sq ft (0.11 yard) and 50 ft (15 m) in diameter.

The waterfront pathway goes from Bayonne, past Liberty State Park and the Statue of Liberty all the way north into Hoboken and is over 18.5 miles long. Rent a bicycle to enjoy it all.

Liberty Science Center is an interactive science museum and learning center located in Liberty State Park in Jersey City, New Jersey. Explore LSC's three themed floors: Environment, Health, and Invention, featuring dozens of exciting hands-on exhibits.

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