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

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

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

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

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?

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.

• CARB VOCs
  • California Air Resources Board Volatile Organic Compounds (CARB VOC)
• 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