CosmeticsThe industry is a huge market across the globe, and the U.S. market is the blue ocean that many cosmetic companies want to enter.But entering the U.S. market is not an easy thing, especially when faced with the various regulations and standards of the FDA.Export to the United StatesWhat needs to be considered? let’s see together.
FDA registration of cosmetic products
FDA cosmetics registration costs are mainly divided into two parts: enterprise registration fees and product registration fees.
Registration fees for enterprises:Usually, a company has to pay a company registration fee once.
Product registration fees:This part of the cost mainly depends on the number of products and the amount of ingredients that need to be declared.
Proposals and points of ISO 22716
ISO 22716 is an international standard on cosmetics production and quality control, and its counselling is usually required in the field.
Expenses for counseling:It is calculated mainly based on the number of peoples days, and the number of peoples days depends on the size of the enterprise, the kind of cosmetics produced, the complexity of the production process and the regulatory requirements of the destination country where the cosmetics are sold.
2) Cost of certification:The same is based on the number of people, but a larger influence factor may be the brand of the certification agency.
Annual maintenance costs:ISO 22716 certificates are subject to supervised audits annually and therefore charge a certain amount of money annually.
FDA Test Factory Advisory and Label Audit
FDA factory counselling and label auditing are two other important links to US cosmetics exports.
FDA Test Factory Advice:Most of the work needs to be done on site, the cost is mainly calculated based on the number of days of work. Factors affecting the number of days of work include the size of the enterprise, the type and quantity of products exported to the United States, whether there is a management system basis such as ISO22716, whether there is a breach record, etc.
FDA Label Audit:This is a non-site service, mainly based on product labels.A class of product labels usually charge a one-time fee.