As a result of major recalls in recent years, the FDA has stepped up its inspection of imports at the time of entry. There are many things that the supplier and importer can do to minimize the risk of a detention – or even worse – a refusal of a shipment.
It is important that both the supplier and importer have an FDA Registration Number if they manufacture, pack, process or hold foods or beverages for consumption.
The newly enacted Food Safety Modernization Act (FSMA) will expand on these requirements. First and foremost, the registration will have to be updated every two years in the last quarter of every “round” year. The first update or renewal is scheduled for the fall of this year.
The foreign supplier must also be sure to submit a Prior Notice before shipping the product to the US. The FDA has established timeframes that must be followed in order to avoid a problem for a missing notification. NOTE: This is in addition to Customs requirements already in place.
These are the only FDA requirements that also include alcoholic beverages although these products still fall under the jurisdiction of the Alcohol, Tobacco, Tax and Trade Bureau.
No FDA Label Approval Process and Preventing Detentions
The FDA is the only federal agency that does not have a label approval process for foods or beverages. It is the responsibility of the manufacturer to ensure that their product fulfills all regulations.
There are many things that can trigger an FDA Detention and several preventative steps that can be taken to avoid it.
Is the mandatory labeling correct, complete and in the appropriate type size? For example:
Does the product name and product description appear on the front of the package?
Is the Net Weight statement in the lower third of the principle display panel? Does it include US measure?
Does the product have Nutrition Facts? If not, did they file for a Small Business Exemption?
Does the nutrition information follow the rounding rules? Is the correct format used?
Problems often occur in the ingredients portion of the label. Manufacturers sometimes literally translate ingredients from their home language into an “English version”. This form may not be accurate or correct. They need to make sure that
a) They are declaring the ingredient according to US requirements
b) Most importantly, that the ingredient is permitted in the US (in some cases, in its current form)
There are often major differences between foreign country and US requirements. It is, therefore, even more crucial that manufacturers do their homework before sending product to the US. FSMA will also put more burdens on the importer to ensure that foods and beverages coming to the US are safe and in compliance.
Some points to watch out for:
Common ingredients are declared one way in other countries and another in the US. A favorite example is “cocoa mass”. This term is used in countless markets, but not here. In the United States, it would be “cocoa liquor”. A label containing the term “cocoa mass” would be in violation because it is not the “common or usual name” of the ingredient.
E-Numbers are not recognized in the US and, therefore, may not be declared on labels in the US. When declaring these ingredients by their actual name, caution must be applied to make sure the declaration is correct – and permitted.
Some E-Number colors are only permitted in the US as certified colors, the so-called “FD&C” numbers. Using the colors in any form other than the certified color is illegal and in violation of the regulations.
Many countries allow plants and flowers as colors in food and beverage products. Not necessarily true in the US. An example: “Safflower” is commonly used in the EU but is not permitted as a color additive in foods in the US.
An illegal ingredient – even just one – can result in “Detention Without Physical Examination (DWPE)” – a.k.a. “Automatic Detention”. This is costly, time-consuming and complicated. And can easily be avoided.
Other ingredient issues:
– Make sure that multi-component ingredients are broken out
– Break out the ingredients of a standardized food that is used within a product (examples: cheese, chocolate, etc.)
It is crucial that the manufacturer be precise in listing all ingredients in their product, particularly allergens. So often the FDA will issue a notice of a voluntary recall for an undeclared allergen in a product. It is dangerous not to list them – and foolish as well. It all comes down to being vigilant and cautious.
Finally, using claims that are not permitted by the FDA have been a source of many a problem for suppliers and their importers. Claims such as “GMO-free” are not permitted here. The FDA’s website has a “Food Labeling Guide”, which also explains in easy-to-understand terms what is permitted and what needs to be fulfilled in order to use a particular claim.
It is important to remember that the FDA is not out to disrupt trade. However, their first and most vital responsibility is to keep the US food supply as safe as possible for everyone. YOU and your suppliers can do your part.
Do your homework! Have an expert review your labels to make sure they are compliant. Let them guide you through the labeling process. It is time and money well spent. Your reputation may depend on it!!
Good luck and happy importing!!
Margaret Eckert is president of Hicksville, NY-based Eurofoods Regulatory Advisory, LLC.