In the USA, cosmetic products and OTCs are regulated at federal level (FDA) by the FD&C Act and the FPLA as well as by local laws in each state. EcoMundo will take care of each step in the compliance procedure, enabling your to market your products in the 50 American states.

 
1

STRATEGIC ADVICE: COSMETIC OR OTC?

In the USA, your products can be classed either as Cosmetics or as OTCs (“Over The Counter”) products

OTCs are drugs which can be sold without a prescription. These products are subject to a specific regulation which is closer to that for medication than that for simple cosmetic products. In particular, it requires the creation of monographs which must be complied with, and includes extremely strict labelling obligations with a format that must be observed very closely (“Drug Facts”).

Therefore, the challenge is first of all to establish whether your products will be subject to the regulation for Cosmetics or to that for OTCs. However, this classification of products is complex as it depends on multiple criteria. It only takes one ingredient considered to be “active” in the USA to automatically shift your product to the OTC category. Claims also play an important role. Categorising a product as an OTC also depends on the product’s “intended use” and functions.

 
  • EcoMundo will accompany you every step of the way in building a product positioning strategy adapted to your ambition on the market, and in classifying your products in the USA as Cosmetics or OTCs.
2

COSMETIC COMPLIANCE

1. Formula review, particularly for colourants

In the USA, cosmetic product formulas are not controlled as rigorously as they are by the European regulation and its annexes. Nevertheless, certain significant constraints do exist, particularly in regard to colourants. It is essential that the compliance of colourants is ensured before the products can be placed on the market.

2. Validation of cosmetic claims

Unlike OTCs, cosmetic products may not have a specific curative or preventive effect. However, it is possible to claim a certain efficacy while ensuring that such claims do not enter into the domain of OTCs as can sometimes be the case with certain anti-aging claims.

3. Compliance of labels

In the USA, labelling rules are extremely stringent and rigorous. The provision of sufficient information enabling the consumer to make an informed choice forms the very basis of the philosophy behind the American regulation. Indeed, a lack of information or non-compliant information is the main cause of infringements found by the FDA. If the labelling on a product is false or incorrect, the product label is deemed “misleading” and “misbranded”.

4. VCRP notification: Voluntary Cosmetic Registration Program

The VCRP (“Voluntary Cosmetic Registration Program”) is a voluntary process for registering cosmetic products that brands can take part in with the FDA.

Although this registration process is said to be voluntary, it is in actual fact highly recommended by the FDA and enables close monitoring of post-marketed products.

 
  • EcoMundo will take care of every step in the compliance procedure, enabling you to market your cosmetic products in the 50 American states.
3

OTC compliance

1. Validation of formula according to the monograph defined by the OTC’s function

The formula of an OTC product must:

  • either comply with the restrictions of an existing monograph
  • or follow those outlined in a new monograph which must be registered – an extremely long and complicated procedure.

For this reason, virtually all companies wishing to place an OTC on the market choose to follow an existing monograph.

In order to comply with a given monograph, some constraints must be respected such as using certain ingredients, observing concentrations, linking active ingredients, etc.

2. Validation of OTC claims

As OTCs are specifically functional or “active” products, it is possible to make relatively exacting claims of efficacy. However, these claims are strictly controlled and must be related to the monograph being followed.

3. Creation of OTC labels & Drug Facts

OTCs are a class of drug or medication. Therefore, a stringent procedure sets out the information which must be displayed on the products. Drug Facts are specific templates which must be followed to the letter to describe the product’s function, the active ingredients contained and the side effects, etc.

Other stringent and specific constraints also regulate the creation of OTC labels. They dictate which information must appear on the product, where this information must be displayed on the packaging, and the character size and font in which the information must be printed, etc.

4. Registration of the product with the FDA: Drug listing

Before an OTC can be placed on the market, the product and all its variants (e.g. different shades for make-up) must be registered with the FDA. In this way, the agency is able to know, at any given moment, which OTCs are available on the market.

5. Registration of the manufacturer with the FDA: Drug Establishment Registration

In the USA, OTC manufacturers must comply with Good Manufacturing Practices (GMPs) when manufacturing OTCs. They must also register with the FDA – Drug Establishment Registration. This registration is mandatory for all manufacturers, including those who manufacture on behalf of third parties (e.g. manufacture of “Private Label” products). These manufacturers are responsible for the OTCs produced, even if they are not marketed under their own brand. Therefore, brands which have their OTCs manufactured by third-party manufacturers must ensure that these manufacturers have a registration certificate. If this is not the case, they must ask them to register the OTC, otherwise it will be impossible to place it on the market.

Manufacturers must obtain a DUNS number and an NDC Labeler Code in order to register via the FDA’s electronic system.

At the end of the registration process, the manufacturer is issued a registration certificate. This certificate only remains valid for one year and must be renewed every year between 1st October and 31st December.

6. US Agent service

The US Agent acts in the USA as the representative of the overseas company wishing to declare the product.

His role is vital. He examines, disseminates, forwards and replies to all communication from the FDA, including emergency announcements. He is responsible for answering any questions concerning the imported drugs or those proposed for import to the USA.

He can also assist the FDA in planning any requested inspections.

 
  • EcoMundo will take care of every step in the procedure for registering your OTC products, and represent you locally before the FDA as a US Agent.