Importing FDA Regulated Products into the United States

Successful launch of a product requires more than a good marketing plan.  It is also important to know whether your product is subject to special regulations from various government agencies.  While the Federal Trade Commission, Consumer Product Safety Commission and even the Environmental Protection Agency have regulatory interests in a number of products, it is the Food and Drug Administration (FDA) that is most closely involved in the regulation of products that touch our lives every day.

Foods, cosmetics, dietary supplements, and over the counter drugs account for a considerable percentage of US consumer spending.  Each of these product categories is subject to scores of unique regulations and labeling requirements.  While confusing enough for domestic producers, proper compliance with FDA regulations can be daunting for importers.  Not only do imported products need to comply with the same regulations as those that are domestically-produced, due to the inspection process, imported products are often held to a higher level of compliance due to the inspection process and are also subject to some additional requirements.

Important Steps for Importers

Before bringing a product to the US market, it is crucial for importers to know whether the ingredients are permitted in the US, whether the manufacturing met required guidelines and whether the label is properly formatted.  Products that contain ingredients that are not permitted for use in the US are deemed ‘adulterated’ by FDA and will not be given entry to the US.  Products that are improperly labeled are considered ‘misbranded’ and will likely be detained by FDA.  In either case, the result is lost time and money along with the discovery that those problems have opened the door to future import frustrations.

In 2018 all provisions of the Food Safety Modernization Act came into effect.  One section of the resulting regulations is the Foreign Supplier Verification Program.   Under this set of regulations ingredient importers are obligated to ensure that their suppliers can meet FDA regulations.  At FDA Compliance Simplified we specialize in regulatory compliance for FDA-regulated products.  We can review your proposed import to ensure the ingredients may be used in the US.  We can tell you whether the label is compliant with US regulations and what other regulatory issues you need to be aware of.  Below is a list of FDA import requirements that we can help you with.

Steps for importing products into the US

  1. You must ensure that your product ingredients are permitted in the US.
  2. If the products include animal-derived ingredients (meat, fish, poultry, eggs, milk, cheese, etc.) you will need an animal ingredient import license from USDA and depending upon the amount and type of the animal-derived ingredient, you may have registrations, regulations and labeling requirements in addition to the ones listed below.
  3. Review FDA Food Safety requirements and GMP regulations to ensure that the facility where the product is being produced can comply with the regulations since the next step, registration, puts you on FDA’s inspection list.
  4. Register the facility(ies) where the products are produced and warehoused.
  5. Process registration for shelf-stable products that have certain pH and moisture levels. This generally refers to any product that is not dry and does not have to be refrigerated or frozen to retain freshness
  6. You must ensure that the product label is in compliance with FDA regulations

You must notify the FDA of your shipments so they can be inspected upon import. There are many regulations pertaining to U.S. Customs and Border Protection and you can read more about that here. It is best to engage a US Customs Broker with experience working with FDA-regulated products to do this.

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