An Introduction to Importing FDA-Regulated Products into the US

As posted here previously, FDA has committed to greater inspection of imported products; particularly imported food and dietary supplements (supplements are regulated as a special class of foods).  

We frequently work with companies that wish to import products into the US and have developed the following list of steps necessary to do so.  Note that each step involves many sub-steps not listed here.  Many of the same steps apply to cosmetic products.  Drugs and Medical devices must first be approved or cleared by FDA for use in the US and then steps 4-7 apply to them as well.

Steps to import foods & dietary supplements into the US

       1.  Register the facility where the products are produced and held. FDA Food Facility Registration and What You Need to Know About Registration of Food Facilities

       2.  Review FDA Food Safety requirements and GMP regulations to ensure that the facilities can comply with them since registration puts you on FDA’s inspection list. See FDA webpage on Food Safety

3     3.  If your product is a liquid or gel and preserved by either a) having a low pH or b) being thermally processed, then you must register your facility (a separate registration than 1 above) and submit your processing steps for FDA review and approval prior to shipping product to the US. (Note: FDA uses the term ‘canned’ food to refer to any shelf stable product that has liquid or gel content.) Information for Aseptic Processors and Acidified or Low-Acid Canned Food Registration

4    4.   You must have a US Agent that is physically located in the US to serve as a domestic point of contact and communication with the FDA. US Agent

      5.  You must ensure that your product ingredients are permitted in the US. Unfortunately, there is not a comprehensive list of what is or is not permitted and not everything that is permitted in the EU is permitted in the US. Even FDA's Everything Added to Food in the United States is only a partial list.

i      6.  You must ensure that the product label is in compliance with FDA regulations FDA Food Labeling Guide; Dietary Supplement Labeling Guide; Cosmetic Labeling Guide

      7.  You must notify the FDA of your shipments so then can be inspected upon import. Prior Notice of Imported Foods

NOTE: This list only covers FDA’s side of importing. US Customs and Border Protection has other regulations which are outside of our expertise.  We recommend that you work with a reputable Custom Broker to ensure compliance with those other import regulations.

We at Bioscience Translation & Application and FDA Labels.com hope that you find this information helpful. Contact us with question or post a comment.

Liquid and Semi-solid Foods and Dietary Supplements

On March 3, 2011 FDA published a final rule that amended 21CFR 113, which regulates ‘thermally processed low acid canned foods in hermetically sealed containers” to allow the use of ‘temperature indicator devices’ other than mercury filled glass thermometers.  So why am I telling you about this?  Partly because what the agency calls ‘canned foods’, which brings to mind metal containers and possibly glass jars, also refers to other aseptically processed foods and beverages. But I tell you about this mostly because this modernization from mercury filled glass thermometers is not the agency’s only recent alertness to this general sector of regulations. You see, the sister regulations for ‘thermally processed low acid canned foods’ are regulations covering the production of ‘acidified foods’-- foods which are not aseptically processed because their pH is low enough to prevent spoilage.

So what?  Well, you and I and FDA have noticed many more liquid dietary supplements in the marketplace.  Most contain acid ingredients and therefore are acidified foods. However, not all manufacturers comply with the regulations of 21CFR114, which require that they register their facilities as acid food producers and file the processes by which they assure that the product will not spoil and cause public harm. This registration is separate from the more generic food facility registration. I wrote about this once before in November of 2010 but I am raising the issue again because I continue to see liquid dietary supplements that have acidic components added to them but whose processes have not be filed with FDA.  Because this regulation is important for ensuring the safety of public health, any violation could cause your company to have to cease production until FDA approves your process and your entire Good Manufacturing Practices (GMP) program. 

I am also concerned about these sister regulations because I have seen a number of liquid ‘alkalinizing’ products on the market—they too would fall under one of these sets of regulations.  The guidance documents for these regulations are really hard to find on the FDA website and an FDA staffer in the office of Low Acid Canned Foods agreed that the regulations are difficult to understand; none the less, if you are producing a liquid or semi-solid product that is preserved in any way, you probably need to pay attention to this. 

If you have any doubt about which regulations apply to your products, contact us by leaving a comment. We are here help.

If you know what regulations apply to your product but need help complying with them—let us know.