Food Regulation in the United States

Does FDA care about all those details on your food product packaging? Absolutely! FDA uses your label as a basis to determine how it will classify your product and what actionable categories it automatically fits into. This makes a big difference when it comes to country of origin, ingredients or food safety in general.

Does FDA care about the little stuff, too, such as your font sizes and location of statements? Believe it. Each year products are delayed, detained or prevented from coming to market because of labeling errors like these. FDA is just as concerned with what’s on the outside of your food product as it is with what’s inside.

Past Success is not Future Success

Food manufacturers and importers face various challenges depending on their degree of involvement and length of time in the business. Experienced manufacturers are struggling to stay on top of emerging trends and legislation but often have a good track record or “know the ropes” about just how much is required to successfully bring a food product to market. New companies or startups, on the other hand, are often on a tight budget, are learning as they go or are lacking sufficient staff/expertise to make strategic legal and regulatory decisions. The challenge for experienced companies is to stay current and not rely on past assumptions; the challenge for newer companies is to invest in preventative maintenance up-front, even though the budget’s tight.

Many food producers run into trouble with FDA when they least expect it. They may have had numerous successful imported shipments in the past but suddenly find themselves with an FDA import detention, FDA refusal or warning letter. This could result from a false assumption that just because they have not had any trouble in the past that it meant they were doing it right. Also, new trends in food safety and legislation can bring a more watchful eye or hands-on approach from FDA. Remember, your product can be detained or flagged even if there is the appearance of a safety violation. Many times there isn’t an issue, just the appearance of one. Both will cost you money. That’s why it’s best to create the best possible label before you ship. The more roadblocks you avoid, the better.

Labeling Requirements

Did you know that the FDA expects the black lines in your Nutrition Facts Panel to be a certain thickness? Do you know what must be present on the Statement of Identity? What addresses must be present and where should they go on your package? FDA regulations are complex and often unclear. What FDA has made available in terms of guidance is just enough so that companies believe they can do it themselves but not enough so that companies actually can. That’s why you need someone in your corner who can serve as a resource to translate what FDA says and to communicate how it impacts your label. It doesn’t matter how great your food product is; if your label is wrong, no one will be buying it.

On May 20, 2016, the Food and Drug Administration (FDA) published updated Nutrition Facts panel regulations for packaged foods. The new rules are making the information more pertinent and accessible by: updating the Daily Values for some nutrients based on the latest scientific evidence, emphasizing caloric content, modifying the “Serving size” for many foods to reflect typical eating habits, including “added sugars” as a subcategory of “total sugars,” and replacing the requirement to include Vitamins C and A with Vitamin D and potassium.

Other Facts About Food Imports

  • Although a foreign manufacturer produced and labeled the food, the U.S. importer is the one responsible for ensuring it complies with FDA regulations. Frequently, foreign manufacturers assure U.S. importers that their labels comply with the regulations, but do so without actually knowing the regulations.
  • FDA does not “pre-approve” food products, or their labels, like it does other industries. This does not mean that they will be lenient, however; it just means that companies can make more errors faster until FDA stops them.
  • While most foods are “non-standardized,” FDA considers some foods “standardized” because they are products for which FDA has created, in essence, recipes for. FDA requires you to follow this recipe, and additional regulations, when selling one of these foods.
  • FDA will carefully examine the claims you make on your packaging, especially as they relate to the health and function of the body, because they are generally not permitted for food products.
  • FDA and FTC (Federal Trade Commission) will hold the manufacturer and distributor or importer responsible for clear and accurate labeling.
  • Disclaimers and warnings are areas that many companies don’t think about in regard to labeling but are immediate red flags if stated improperly.
  • If FDA does hold or detain your product because of a labeling error, there is no way to know how long it will take for them to assess and notify you about the issue or to explain what must be changed in order for your product to be released.
  • The Food Safety Modernization Act is the largest body of changes in food regulation in decades and is being implemented in phases every 6 months until 2013. The requirements and implications for the food industry are staggering.
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