Who’s behind CosmeticLabelRight.com?

CosmeticLabelRight.com is a project of Maryland-based consulting firm FDAImports.com. Led by Founder and CEO, Benjamin England, FDAimports.com is a unique firm made up of consultants, marketers and affiliated attorneys serving international and domestic clients of all shapes and sizes. Mr. England is a 17-year veteran of the U.S. Food and Drug Administration with 25 years of direct FDA-related experience, and now leads FDAImports.com and ExportToUsa.com.cn, our Chinese office. CosmeticLabelRight.com is one of 5 sites developed specifically for helping companies with FDA labeling compliance.

How Does It Work?

You simply fill in your contact information and upload all your labels in any electronic image format. If you received an FDA warning letter, FDA Form 483, FDA detention notice or FDA notice of refusal of admission you can upload that as well. We will perform a fast initial review of all your documents and labels and respond back to you via email with the exact cost of your full label review and any other regulatory assistance you probably will need. Next you simply engage us to do the work, pay the cost and we perform the full-scale in-depth review. The whole label review process can be completed in as little as 3 days. Anything you upload will be kept confidential by our firm and we will not share your information with any third-parties.

Is it Free?

It’s free to upload your labels and receive your estimate. You’re not committed to pay anything for this initial step. We determine an exact cost for your label review based on the complexity of your product and packaging. You’re not committed to pay anything unless you want the label review. A typical review for a cosmetic product costs between $1750 and $2250. Volume discounts may apply. In our email we’ll provide you with a payment link so that you can immediately submit your payment for faster processing. We accept all major credit cards, PayPal or check. We are based in Baltimore, MD and have been successfully helping companies all over the world with FDA compliance for years.

Is There a Discount for Multiple Labels?

Yes! We know that many companies produce a variety of products and we want to be your #1 resource for FDA compliance consulting. If you have more than 4 labels to review at a time we will create a special discount for you. We are especially committed to helping small businesses and startups so please don’t hesitate to upload all of your documents at once so that we can work with you on a great discount. Just indicate in the “notes” area that you’re uploading 4 or more labels.

What Will I Get?

You will receive an electronic opinion letter containing a detailed assessment of every single portion of your label or package under the applicable laws and regulations. We will provide all of the following organized by panel and by area (Ingredients, claims, etc…)

• What is correct and does not need to be altered?
• What is incorrect and why you need to change it?
• What could potentially cause an issue and how you can minimize the risk?
• The FDA regulations behind everything we discuss.

How Fast Is The Process?

The label review will begin upon successful receipt of your full flat-fee payment. The typical completion time is 10 business days after payment, however, we can provide rush services for an additional premium.

Does your cosmetic contain Sun Protectant related ingredients, intended use, or claims?

Frequently, products that are regulated in other countries as 'cosmetics' are regulated as 'drugs' in the United States. This is generally the result of the cosmetic product containing ingredients that are considered active drug ingredients, according to FDA's OTC Monographs. Sun Protectant Factor (SPF) ingredients are active drug ingredients and products containing such ingredients are regulated in the United States as drug products. If your product contains SPF, visit us at DrugLabelRight.com.

Alternatively, we frequently recommend that companies with these type of products obtain a Regulatory Review. Our Regulatory Review of the product details the requirements for marketing it in the United States. This includes classifying the appropriate OTC Monograph, analyzing the active and inactive ingredients and detailing your registration and drug listing requirements, should the products be regulated as a drug in the United States.

What If I Need Custom Consulting or Research?

New product consulting, legal counsel, facility registration/Inspection services and more are available directly through our consulting firm, FDAImports.com. LEARN MORE

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