USA OTC

Cosmetics testingCosmetics testingCosmetics testing

CE.way Regulatory Consultants provide essential OTC services for businesses seeking to expand their product portfolios into the USA. We offer the required skills, knowledge, and expertise to navigate the complex regulatory landscape governed by the US Food and Drug Administration (FDA) and other relevant authorities.

Why are we offering this additional service?

In the USA, the FDA classifies products as cosmetics when they are intended to clean, beautify, or promote attractiveness, or when they alter appearance without affecting the body's structure or functions. However, when a cosmetic product claims to treat or prevent a disease or affect the body's structure, it may be classified as a drug or an Over-the-Counter (OTC) drug. This classification subjects the product to more stringent regulations.

This distinction requires a thorough and robust understanding of the regulatory framework (Ref: 21 Code of Federal Regulations (CFR) Subchapter C and Subchapter D).CE.way provides crucial services to manufacturers and brand owners to ensure compliance with these regulations.

Examples of OTC products include:

Anti-perspirant deodorants (OTC Monograph ID M019)

Acne products (OTC Monograph ID M006),

Products formulated with sunscreens designed to protect the skin with SPF values (OTC Monograph ID M020)

Dental products formulated to prevent tooth decay (OTC Monograph ID M021),

And many other products that impact the structure or function of the body.

By offering OTC consultancy services, we enable brands to focus on product innovation while CE.way manages the regulatory compliance framework, ensuring products are successfully listed with the FDA and thereby enabling success in the US market.

CE.way OTC Consultancy Services

Our OTC consultants assist companies in ensuring compliance with FDA regulations through the following services:

Cosmetics regulatory
1

Product Development Guidance

Our consultants provide expertise in formulation, advising on the most appropriate monograph for the product and the allowed active ingredients. We also guide ingredient selection to maximize compliance across all US states, avoiding the need for multiple formulations.

2

OTC Product Labeling

The FDA stipulates specific labeling requirements, including product identity, net contents declaration, ingredient lists, clear directions for use, and required warnings and precautions. Our consultants ensure that all products are labeled correctly to meet these requirements.

3

Product Claims Substantiation

All claims and benefits made on the product label must align with the relevant monograph and be substantiated with scientific data. We provide robust data that meets FDA standards, avoiding misleading claims and potential litigation for misbranded products.

4

Essential Manufacturing Details

Our consultants guide production facility requirements, including FDA approval, robust quality management, and adherence to Good Manufacturing Practices (GMP).

5

Adverse Event Reporting and Post-Market Surveillance

Ongoing compliance is crucial once a product is on the market. Our services include monitoring product performance, managing consumer feedback, and guiding adverse reaction reporting to the FDA, protecting both consumer safety and brand reputation.

6

State Regulations

Certain states, such as California with Proposition 65, have their own regulations. Our consultants provide the most up-to-date information on state-specific requirements to ensure full compliance.

7

FDA Establishment register

All manufacturing facilities must annually register with the FDA, our consultants can provide intel on this matter.

8

FDA Product Listing

Our services will ensure successful product listing and maintenance of same on the FDA registrar.

These services enable businesses to successfully navigate the intricate landscape of OTC regulations for cosmetic products in the USA. Our expertise not only protects brand reputation and facilitates successful FDA product listing but also future-proofs businesses against upcoming regulations, allowing them to continue focusing on innovative product development.

And what do they say about us?

Pharmaplast began to work with CE.way almost one year ago. CE.way is our cosmetics consultant who look after compilation of PIF, safety assessments and CPNP notifications. In addition to this, CE.way is our European representative as our company is not located in Europe. Working with CE.way has been a joy so far. Their replies are very swift and Mr Tadej is very cooperative, helpful and with a deep knowledge about the cosmetics regulations. In addition to this, CE.way is very cost effective company in comparison with their European counterparts. For all the above reasons, I really recommend CE.way to other cosmetic product manufacturers.

Mena, Egypt

Pharmaplast

We were looking for a stand-alone service, not too sure what to expect... The professionalism, the assistance and the responsiveness were very much appreciated, amongst the best we have ever experienced.

Carol, Switzerland

Alpure

We are a small manufacturing company located in the US. We recently used CE.way Regulatory Consultants to help guide us through the Cosmetic regulatory changes that have taken place in the EU. They were instrumental in helping us understand the new laws and streamline the entire process. I would highly recommend their services.

Lena and Clay, USA

IBP

We didn't have any knowledge about the registration process for cosmetics in EU and were very concerned about this, but we met CE.way and they gave us whole packages of consultation and support. It was really helpful and we could do the registration without any problem. We will definitely ask CE.way again when we have new product to register in EU.

Masa, Japan

Nash Corporation

We used Tadej and CE.way for EU compliance with our products. He was very helpful and worked directly with our lab which made the process much easier for us. Tadej worked with me directly on all of our products to make sure I had the right documents. I really liked the attention to detail and how I could work with the owner of the company directly. I would highly recommend their services.

Steve, Canada

Curly Hair Solutions

Tadej from CE.way is the best consultant I've ever worked with. It's a great luck that we've found him. He is knowledgeable, fast, helpful & always ready to answer a million questions that we have. We had no exposure to cosmetics market before, so we didn't even know where to start. So he helped us to do EVERYTHING. The quality of service for the amount of money that we pay is absolutely the best! BIG THANK YOU to you Tadej & we'll definitely keep working with you!

Natalia, USA

Hi Tadej, Thank you for your highly professional approach, extremely helpful information and advice on getting our product registration under way and completed in record time! What we thought to be a very tiresome and laborious task was made quick and simple. Thank you again! The Thermitek Team.

Rene, Greece

Funkitup

It's been our first time lodging an application for EU Compliance. Although a big task, Tadej from CE.way made it as painless as possible. His patience and help were invaluable. He was so responsive and was available at all times to work with myself and my manufacturers. We now have our first round of product successfully assessed and notified. I will be placing our next round asap for notification, I can't recommend CE.way highly enough, thanks Tadej - Heather Spierings Eye of Horus Cosmetics.

Heather, Australia

RA Cosmetics

CE.way offers professional and reliable service. The team is diligent and extremely helpful throughout the whole process. We are very satisfied the way the work was executed. We definitely recommend CE.way to others.

Tamar, USA

Nuvision

CE.way made the whole EU process easy to understand. They were very responsive to all our needs.

James, USA

Eufora

This is a major investment for a small business like ours and it took me a few years to find a company (CE.way) that I felt comfortable working with! That speaks volume to my appreciation of the quality of your communications with me.

Vivian, USA

VB cosmetics

Our company had a great experience with CE.way. They were very organized and provided us with a detailed roadmap of exactly what we needed to gather on our end for them to put together our Product Information File and complete the notification process for the EU. They continued to help us along the way, providing quick feedback on any changes we needed to make to a document for it to work and reminders on what we still needed to provide. They are organized, knowledgeable, fast, and attentive; I would absolutely recommend them to any companies looking to get their products approved in the EU.

Cyrus, USA

SBBM

CE.way's assistance was tremendous, helping our company navigate the EU cosmetic regulation and efficiently get products to market.

Mike, USA

Inverness

Our cooperation with Tadej and his team at CE.way Consultants aimed to assist us to launch our products in UK for the first time. Tadej is a very hands on and always quick with his responses. The process was smooth and beyond our expectations in terms of cost savings and the speed with which we accomplished our goal. We look forward to working with them again.

Ruta, UK

Art de Parfum

We are really appreciate your speedy replies and clear and understandable guide. As there are a lot of differences in cosmetic regulations between Japan and EU first we thought that it would be hard to make all necessary procedures for our products compliance with EU laws, but thanks for your prompt support, all procedures were made smoothly. And now we are successfully selling MT Metatron in EU. We also thinking to expand our other brands in EU and when we start - definitely will ask your company for assist again.

Olga, Japan

MT Cosmetics, Inc.

After a less than pleasurable experience with another company, we found CE.way and we can honestly say that it could not be more beneficial for our brand. The whole notification process is made as easy as possible. The people at CE.way are all very accessible, knowledgeable and always ready to answer questions. CE.way is a great asset to our company and we are grateful for all the help and support we receive. Navigating through all rules and regulations alone is impossible, with the team at CE.way, we have the best support that we could ask for. Highly recommended in all aspects from their support to their reliable service!

Daniel, USA

NCLA

Testimonials

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