Toll Free: +1-888-717-2436

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 :-
South Beach, FL
| Thursday, November 13, 2014 | Friday, November 14, 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

November 13-14, 2014, South Beach, FL

You Save: $2,195.00 (24%)*

Special Group Discount Register for Six attendees

November 13-14, 2014, South Beach, FL
*Hurry! This option is limited and based on availability.
Great Savings with Group Ticket!!! Only 3 left

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.

For discounts on multiple registrations, contact customer care at +1-888-717-2436.

Register by P.O. / Check

Yes, I want to attend "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".

If you are paying by check:

Checks should be payable to MetricStream Inc. (our parent company) and mailed to:
2600 E. Bayshore Road
Palo Alto, CA 94303

Group Registrations

Significant tuition discounts are available for teams of two or more from the same company. You must register at the same time and provide a single payment to take advantage of the discount.

2 Attendees - Get 10% off
3 to 6 Attendees - Get 20% off
7 to 10 Attendees - Get 25% off
10+ Attendees - Get 30% off

Register by Wire Transfer

Terms & Conditions to Register for the Seminar/Conference/Event

Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @

Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).

Cancellations and substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $150 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days before the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($150) will be transferred to any future ComplianceOnline event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.

In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Attendance confirmation and documents to carry to the seminar venue:
After we receive the payment from the registered attendee, an electronic event pass will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the venue of the event.

Conference photograph / video:
By registering and attending ComplianceOnline conference, you agree to have your photographs or videos taken at the conference venue and you do not have any objections to ComplianceOnline using these photos and videos for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline from any kind of claims arising out of copyright or privacy violations.


Location :

View Larger Map

Media Partners


Media Partner Benefits
  • Logo and company data on the event website.
  • Logo on the conference material distributed during the conference.
  • Media partner’s brochure distributed along with conference material.
  • Logo on all the mailings before and after the event.
  • 10% discount to media partner's subscribers.

Media Partner To Do
  • Banner (min 728x90 or 468x60) on the media partner website.
  • Insertion of the event in the event calendar, both printed and/or online.
  • Announcement article of the conference on the magazine and/or website.
  • Dedicated email blast to media partner’s subscribers.
  • Article on the magazine and/or website after the conference.

Local Attractions

The nation's largest 20th Century National Register Historic District. The area features more than 800 historic buildings erected during the 1920s, 30s and 40s, and contains a variety of architectural styles. Walking, bicycle and private group tours are available.

The Jewish Museum of Florida-FIU, heralded as the "jewel of South Beach," serves as a major cultural attraction and source of information for a wide audience of residents, tourists, students and scholars of all ages. It is the only museum dedicated to telling the story of 250 years of Florida Jewish heritage, arts and culture.

It is among the most popular destinations for visitors to the South Beach area. Located between Alton Road and Washington Avenue, Lincoln Road offers unique shopping, sidewalk cafes, bars, galleries, and fine dining. Lincoln Road is also the best people-watching spot on South Beach.

The Wolfsonian–Florida International University is a museum, library and research center that uses its collection to illustrate the persuasive power of art and design. The Wolfsonia collections comprise approximately 120,000 objects from the period of 1885 to 1945—the height of the Industrial Revolution to the end of the Second World War.

This is the easternmost road in South Beach, running north-south from First Street up to 15th Street. This colorful stretch has been showcased in many movies and is what most visitors probably imagine when they think of South Beach. It is also home to several prominent restaurants (including "News Cafe," "Mango's," and the MTV-popularized "Clevelander") and is the site of Gianni Versace's former ocean front mansion.

South Beach is famous for its ever-changing club scene. When the sun sets on South Beach, daytime shoppers become nighttime club-hoppers at a diverse array of nightspots. Clubs in South Beach include dance clubs but also hotels, lounges and even restaurants after midnight, pumping out music of all kinds and catering to a straight, gay or mixed clientele.

Washington Avenue is one of the best-known streets in South Beach. Running parallel with Ocean and Collins, Washington is notorious for having some of the world's largest and most popular nightclubs, such as Cameo and Mansion. Washington Avenue is also home to countless shops, hotels, and such noted architectural features as Temple Emanu-El.

Its charming architecture and terracotta-tile roofs are reminiscent of Old Europe. It’s more low-key than Lincoln Road and attracts a Bohemian crowd to its many art galleries, outdoor cafés, and unique shops.

South Pointe Park on South Beach is an animated renovated park that features ecologically sensitive and hurricane resistant design. The park offers various features, including a restaurant, kids area, a dog park, and outdoor showers.

We need below information to serve you better