UNITED STATES FDA
KEEP YOUR PRODUCTS ON THE SHELF!
We help you meet U.S. cosmetics requirements.
U.S. FDA Compliance
Meeting U.S. compliance and following the FDA requirements can often be challenging. At International Cosmetics, the goal is to properly classify each product while being mindful of the desired market placement.
Cosmetic, Over-The-Counter Drug, Homeopathic, Medical Device, Rx (prescription) or New Drug, will each be required to comply under 21 Code of Federal Regulations. Compliance starts with the formula and ingredients then expands to the manufacturing facility where Standard Operating Procedures and process
give way to product testing, plant processes, validation and quality requirements.
Let International Cosmetics partner with you in all facets of your product’s growth and compliance.
Our services include:
- Labeling & Claims Compliance for Cosmetics and Over-The-Counter Drugs
- FDA e-Registrations
- U.S. FDA Agent for foreign manufacturers
- Provide Compliance Services for Good Manufacturing Practices
- FDA 21 CFR 211 Gap Audit and Training
- ISO 22716 Gap Audit and Training
- Labeling & Claims Compliance for Cosmetics and Over-The-Counter Drugs
- FDA e-Registrations
- U.S. FDA Agent for foreign manufacturers
- Provide Compliance Services for Good Manufacturing Practices
- FDA 21 CFR 211 Gap Audit and Training
- ISO 22716 Gap Audit and Training
Cosmetic Labeling & Claims Compliance
Product can be stopped at US Customs at any point. Don’t take the risk. No one wants the disruption in their supply chain or damage to their brand.
Taking a risk on how a product is labeled by not having a professional review or choosing to risk not following recommendations of regulatory professionals will ultimately result in FDA enforcement. The label and what is written about your product is the first glimpse by the FDA for compliance. Depending on what you say about your product(s), how you say it and/or how the consumer perceives the effects that are promised, can have a negative impact from the FDA viewpoint. What may be presented as a cosmetic may be reviewed by the FDA as a drug.
Potential Areas of Enforcement:
- Labeling Format
- Ingredients (don’t assume
your ingredients are legal!) - Claims
- Product Classification
- Consumer Perspective
- Labeling Format
- Ingredients (don’t assume
your ingredients are legal!) - Claims
- Product Classification
- Consumer Perspective
Over-The-Counter Drugs & Medical Devices
FDA Facility / Product e-Registration
e-Facility Registration
The FDA now requires e-registrations. We have been providing e-registrations since the birth of the program in 2009, for both U.S. and non-U.S. companies of all sizes. International Manufacturers, Fillers & Packagers must use a US Agent for these registrations. A company may only have one US Agent.
While the task may seem easier, many U.S. companies have found FDA’s IT system difficult to navigate.
U.S. companies without current registrations may trigger an FDA audit and risk receiving a WARNING LETTER that is publicly available, risk triggering a recall and preventing OTC manufacturing! Our qualified team can handle this daunting task as well as list your products correctly and efficiently in this electronic program.
e-Product Listing
After getting this far and having a company registration, the most difficult part is yet to come. All Over-The-Counter Drug products must be FDA e-listed (registered). Listing is not a new requirement, but working under the ever-changing FDA IT electronic program is.
All OTC drug products and Medical Devices must have current registrations. US-made products must be registered within 10 days of placing product on the market. Internationally-made products must be registered before entering US Customs. This will avoid products being detained and identified by the FDA as MISBRANDED. This can result in the products being quarantined, rejected or destroyed. Quarantined products incur significant storage fees until the FDA is assured of compliance at their own convenience.
FDA US Agent Services
For companies outside the US, a US Agent is required. We provide this representation as part of our FDA Registration services. This requirement applies to International Manufacturers, Fillers & Packagers.
It can be difficult for incoming products to clear US Customs. No need to panic! We have refined the process and are here to help you. We are qualified to assist in getting product into the US. Any non-US company importing products into the US that fit the Over-The-Counter Drug and Medical Device category will need International Cosmetics help to avoid distribution interruption. Only one US Agent can be assigned in each calendar year. International Cosmetics has been providing this service since 2001.
Good Manufacturing Practices (GMPs)
US GMP 21 Code of Federal Regulations addresses Cosmetics, OTC / Prescription Drugs and Medical Devices. The requirements under 21 CFR are complex, but we have the wisdom and experience to help you understand how these are to be fulfilled.
US GMP 21 CFR 211
The United States has had GMP requirements for products since the early 1970s. International Cosmetics has been providing this service since 1997 as a third-party auditor for compliance as well as other facets of this regulation.
- Standard Operating Procedures (SOPs)
- Specification Development
- Testing Requirements
- GMP Gap Analysis
- Training
- On-Site Support for FDA Inspections
GMP Audit
Since 1997, we have been providing GMP audit services both domestically and internationally. With our many years of experience, we bring practical in-depth knowledge of manufacturing processes. We have performed audits in domestic and international facilities, such as Germany, Switzerland, Poland, the UK, Mexico, Japan, China, and others.
All manufacturing facilities must follow GMP requirements to ensure your products stay on the shelf and are FDA compliant.
We offer:
- 21 CFR GMP Audits
- ISO 22716 Cosmetic GMP Audits
When FDA comes knocking at your door, will you be ready?
ISO 22716 GMP
Since the issuance of the International Standards Organization (ISO) Cosmetics GMP 22716, the US FDA, the European Union and many other countries have adopted this standard as a requirement for cosmetic products offered for sale.
As Designated Experts, International Cosmetics participated in the creation and development of ISO 22716 and continues to be involved with updates and the ISO proceedings internationally.
Our services include:
- Training
- Certification
- Auditing
- Training
- Certification
- Auditing
GMP Training
cGMP (Current Good Manufacturing Practices) training is required to comply with these regulations. Regulations are only part of the requirement. As experienced Auditors, we provide mandatory training to meet GMP criteria for your participating staff members. These individuals must stay current with ongoing training and keep records accordingly. We provide off-site classes custom tailored to your needs.
STATE REGULATIONS
In addition to Federal requirements, some State laws are also applicable to consumer products, including cosmetics.
- Proposition 65 (Prop 65)
- Labeling requirements that are ingredient specific and may not be obvious
- California Safe Cosmetics
- Notification requirement all products containing chemicals known or suspected
to cause cancer, birth defects or other reproductive toxicity includes ingredients
from Proposition 65 and other lists - Children’s Products
- Some states have specific regulations for children’s products
- Safer Consumer Products (Green Chemistry)
- Scrutiny of product categories and ingredients for further restrictions.
- Waste Water Contaminants
- 1, 4-Dioxane restrictions in cosmetic ingredients
- Proposition 65 (Prop 65)
- Labeling requirements that are ingredient specific and may not be obvious
- California Safe Cosmetics
- Notification requirement all products containing chemicals known or suspected
to cause cancer, birth defects or other reproductive toxicity includes ingredients
from Proposition 65 and other lists - Children’s Products
- Some states have specific regulations for children’s products
- Safer Consumer Products (Green Chemistry)
- Scrutiny of product categories and ingredients for further restrictions.
- Waste Water Contaminants
- 1, 4-Dioxane restrictions in cosmetic ingredients
Let us help you with these complex regulations.
The service you don’t think you need…until you do!
OUR SERVICES
Cosmetic regulatory expertise in these countries and around the globe
Latest news about the US FDA
The deadline for registering your OTC products is approaching. From October through December 31st you must register your over-the-counter products. International Cosmetics can take care of this for you, and don’t worry! If you miss the deadline, we can still help!
Latest Regulatory News
California passed SB 312, or the Cosmetic Fragrance and Flavor Ingredient Right to Know Act, or CFFIRKA. It is likely that most cosmetic products will be required to notify. Read More...
An expert in the field of international Cosmetics, putting her best face and hair forward, Cheeky International is the newest member of International Cosmetics. As an expert spokesbrush of International Cosmetics & Regulatory Specialists, L.L.C. in the U.S. and International Cosmetics & Chemical Services, Ltd. in the UK & EU, she guides her clients through the complex maze of constantly changing regulatory laws. Cheeky’s extensive experience has given her unique expertise in worldwide regulatory systems, with a specific focus on the European, United States and Canadian cosmetic industries.
Let us be your RP!
We offer an EU-UK
Dual Representation Package
And we have our own in-house
Safety Assessors
NYSCC SUPPLIERS' DAY 2025
New York, NY
Jacob K. Javits Convention Center
June 3rd - 4th 2025
Booth # 674
UNITED STATES
International Cosmetics & Regulatory Specialists LLC
947 Manhattan Beach Blvd. Suite A
Manhattan Beach, CA 90266 USA
+1.310.545.3223
EUROPEAN UNION (EU)
International Cosmetics & Chemical Services, Ltd
Dublin, Ireland
+353 1 2343750
UNITED KINGDOM (UK)
International Cosmetics & Chemical Services, Ltd
West London, England
+44(0)1753.680980