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
San Diego, CA
Tuesday, March 10, 2015 | Wednesday, March 11, 2015
Thursday, June 4, 2015 | Friday, June 5, 2015
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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San Diego, CA(Venue to be announced shortly)
March 10-11, 2015
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June 4-5, 2015
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San Diego, CA, Local Attractions
Chicago, IL, Local Attractions
San Diego Cabrillo National Monument
The first European to set foot in California was the Spanish explorer Juan Rodriguez Cabrillo, who stepped on shore near this spot in in 1542. He's the guy they made this statue to look like - and named the park after. We don't know if Cabrillo climbed all the way up to the top of this promontory or not, but people who make up here nowadays get some of the best views of San Diego, looking across the Bay and back toward downtown.
Sea Creatures at Birch Aquarium
Birch Aquarium is north of San Diego in La Jolla. It's not as big as some of the other aquariums in California or as flashy as the big sea-themed park down the road, but instead just right, filled with interesting exhibits and home to leafy sea dragons like the one above, creatures so improbably they look more like something from a children's book than from the ocean.
Legoland theme park takes its inspiration from Lego toys, those cute little bricks that snap together to build all kinds of fun things. It's one of several Legolands worldwide.
San Diego Zoo Safari Park
The San Diego Zoo's sister park offers a different kind of animal experience. Its name (Safari Park) is the clue and it indeed offers a more safari-like experience. Lots of large animals live in the same big, open areas here - predators kept away from prey, but otherwise much as they would in their natural habitat.
Coronado isn't really an island but a peninsula - a fact that doesn't get in the way of the name most people use for it. Whatever you call it, it's on a slender strip of land between the San Diego Bay and the Pacific Ocean, barely a few blocks wide. What it lacks in size it makes up for in fun, with a beach that's been named among the best in the country, a classic hotel and a compact, lively little downtown. Coronado's laid-back temperament makes a nice break from the busier parts of San Diego across the water.
Originally built for temporary use during the 1915-16 Panama-California Exposition in San Diego, Balboa Park boasts buildings beautiful enough to be considered attractions in themselves, especially if you're a photographer. They're surrounded by trees, lawns and fountains, but that's only the beginning.
In Spanish, La Jolla means "the jewel," an apt name for a pretty, Mediterranean-style seaside town - sitting on cliffs flanking the ocean.
La Jolla visitors like to shop and eat in the nice restaurants, some of them with lovely ocean views. There's a lot for the active visitor, too, including ocean kayaking, tide pool-hopping, surfing at Windansea Beach, biking or running along the waterfront.
One of the more breathtaking scenes on the lake is this tall ship approaching the docks at Navy Pier. The 148-foot four-masted schooner (and its new sister ship, the Windy II ) sets sail for 90-minute cruises two to five times a day, both day and evening. (Because the boats are sometimes booked by groups, the schedule changes each week; call first to confirm sailing times). The boats are at the whims of the wind, so every cruise charts a different course. Passengers are welcome to help raise and trim the sails and occasionally take turns at the ship's helm (with the captain standing close by). The boats are not accessible for people with disabilities.
Adler Planetarium and Astronomy Museum
The building may be historic (it was the first planetarium in the Western Hemisphere), but some of the attractions here will captivate the most jaded video-game addict.
Your first stop should be the modern Sky Pavilion, where the don't-miss experience is the StarRider Theater. Settle down under the massive dome, and you'll take a half-hour interactive virtual-reality trip through the Milky Way and into deep space, featuring a computer-generated 3-D-graphics projection system and controls in the armrest of each seat. Six high-resolution video projectors form a seamless image above your head -- you'll feel as if you're literally floating in space. If you're looking for more entertainment, the Sky Theater shows movies with an astronomical bent; recent shows have included Secrets of Saturn and Mars Now!
Arlington International Racecourse
With its gleaming-white, palatial, six-story grandstand and lush gardens, this racecourse is one of the most beautiful showcases for thoroughbred horse racing in the world. Its storied history stretches back to 1927, and such equine stars as Citation, Secretariat, and Cigar have graced the track. The annual Arlington Million (the sport's first million-dollar race, held in mid-Aug) attracts top jockeys, trainers, and horses and is part of the World Series Racing Championship, which includes the Breeders Cup races. Arlington's race days are thrilling to behold, with all of racing's time-honored pageantry on display -- from the bugler in traditional dress to the parade of jockeys.
Art Institute of Chicago
You can't -- and shouldn't -- miss the Art Institute. (You really have no excuse, since it's conveniently located right on Michigan Ave. in the heart of downtown.) No matter what medium or century interests you, the Art Institute has something in its collection to fit the bill. Japanese ukiyo-e prints, ancient Egyptian bronzes, Greek vases, 19th-century British photography, masterpieces by most of the greatest names in 20th-century sculpture, and modern American textiles are just some of the works on display, but for a general overview of the museum's collection, take the free "Highlights of the Art Institute" tour Saturday and Sunday.
Auditorium Building and Theatre
A truly grand theater with historic-landmark status, the Auditorium gives visitors a taste of late-19th-century Chicago opulence. Because it's still a working theater -- not a museum -- it's not always open to the public during the day; to make sure you'll get in, schedule a guided tour, which are offered on Mondays at 10am and noon.
Designed and built in 1889 by Louis Sullivan and Dankmar Adler, the 4,000-seat Auditorium was a wonder of the world: the heaviest (110,000 tons) and most massive modern edifice on earth, the most fireproof building ever constructed, and the tallest building in Chicago. It was also the first large-scale building to be lit by electricity, and its theater was the first in the country to install air-conditioning. Originally the home of the Chicago Opera Company, Sullivan and Adler's masterpiece is defined by powerful arches lit by thousands of bulbs and features Sullivan's trademark ornamentation -- in this case, elaborate golden stenciling and gold plaster medallions. It's equally renowned for otherworldly acoustics and unobstructed sightlines.