United States/California

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:

  • FDA e-Registrations
  • Prop 65
  • Good Manufacturing Practices
  • ISO 22716 audits
  • Organic and natural claims
  • U.S. agent for foreign manufacturers
  • Volatile Organic Compounds (VOC)
  • SB484 - California Safe Cosmetics Act
  • FDA 21CFR211 Gap audit and training

U.S. Agent Services

It can be difficult to steer U.S. Customs for incoming products. However, we are trained to help you get your product across international lines. Any non-U.S. company importing products into the U.S., which contain an SPF, make acne claims or have acne ingredients, antiperspirants, fluoride toothpaste and others, will need International Cosmetics to keep the product distribution running.

GMP Audit/Gap Analysis

cGMP Audit

If a product is "ready to market," the facility must be compliant for the market or the product is not ready. Our staff has more than 50 years of experience in FDA compliance and inspections inside and outside the U.S.
 
We offer audits for compliance with ISO 22716, and FDA-preparation audits, which we have done in domestic and offshore facilities in Germany, Switzerland, the U.K., Japan, China, and others, in both small and large facilities.

cGMP Training

cGMP (Current Good Manufacturing Practices) training is required to comply with the new regulations. The Regulation is only part of the requirement. Persons trained in this area must be current in the training and must keep a record of their training on an on-going basis.

FDA e-facility / Product 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.

While the task may seem easier, some U.S. companies have found it difficult. But no one needs to panic!  We have refined our process and are here to help you. For companies outside the U.S., the U.S. Agent provides this representation as part of its service.

e-Product Listing

U.S. companies without current listings may trigger an FDA audit and risk receiving a published-warning letter. Our qualified team can handle this daunting task and list your products correctly and efficiently in this new electronic program.

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. Listing is not a new requirement, but listing under the new electronic program is. If the listing is not current for the year, the FDA can take action. If products are brought through U.S. Customs and not cleared by the FDA, they can be quarantined, rejected or destroyed. Quarantined products incur significant storage fees until the FDA is assured of compliance.

Labeling & Claims Compliance

Labeling and claims compliance can be compared to California fires…you may have a few years of good rain fall, but when the hot dry winds begin and rain fall is low and drought conditions high, there will be wild fires. 

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 of some sort.  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.  

California

  • CARB VOCs
    • California Air Resource Board Volatile Organic Compounds (CARB VOC)
      • CARB survey for 2013 due March 2015
  • Proposition 65
    • Labeling requirements that are ingredient specific
  • California Safe Cosmetics
    • Notification requirement all products containing chemicals known or suspected to cause cancer, birth defects or other reproductive toxicity includes ingredients from Prop 65