As discussed in prior blog posts, the Food Safety Modernization Act (FSMA) aims to prevent contamination of the United States food supply by requiring that food facilities be in compliance with a series of regulations in order to distribute products in the U.S.  The FSMA was signed into law by President Obama on January 4, 2011.    

 The FSMA requires that all food facilities, domestic and foreign, be registered with the US Food and Drug Administration (“FDA”) in order to manufacture, process, pack, or store food for animal or human consumption in the US.[1]  If a facility fails to comply with the registration requirements, products manufactured by foreign facilities will be refused entry into the U.S. and domestic facilities will be unable to legally sell products in interstate commerce.[2]  Every two years, every food facility must renew its registration.[3]  Facilities that registered prior to October 1, 2012 must renew their registration. [4]

The FSMA has granted the FDA greater authority to hold imported foods to the same standard as domestic foods—making it even more difficult for companies who wish to import into the US food from other companies.[5]  Importers are now required to verify that any foreign suppliers have controls in place to guarantee that the food they produce is safe.[6]  Qualified third parties are now able to certify that foreign food facilities are in compliance with U.S. food safety standards.[7]  Foreign facilities that produce foods that are at a high risk of contamination may be required to receive third-party certification or another form of compliance in order to be admitted into the US.[8]  The FDA is able to refuse entry to food from any facility that has denied the FDA inspection access or is located in a country that has denied the FDA access.[9]

Although the FSMA presents challenges to food companies, if companies educate themselves on the registration requirements and pay close attention to their suppliers, they will be in compliance.  Additionally, importers that are offering food from program-certified facilities are able to participate in a program that expedites the process.[10]

Continue Reading Minimizing the risk of litigation by complying with the Food Safety Modernization Act

Certified Gluten Free Lable

The Food & Drug Administration (FDA) is preparing to release a regulation on the labeling of “gluten-free” food by the end of 2012. Although the regulation will provide much needed guidance to consumers and food manufacturers, it will also establish a standard that food manufactures will need to follow in order to use a “gluten-free” label.  If food manufacturers use the “gluten-free” label without properly following the regulation, they could face lawsuits from consumers purchasing their products.

An increasing number of people in the U.S. follow a gluten free diet.  Gluten is a protein contained in grains such as wheat, barley, rye and triticale.  Packaged Facts, a Maryland based research firm, estimates that U.S. retail sales of gluten-free products in 2010 was $2.3 billion dollars, up from $1 billion dollars in 2006.  The firm projects retail sales of gluten-free food to reach $2.6 billion in 2012, and $5.5 billion in 2015.

Although the recent increase in dollars spent in the gluten-free market presents opportunities to businesses, it also presents risks.  People choose to follow a gluten-free diet for a variety of reasons, and some individuals require that food they consume be prepared in a completely gluten-free environment. If individuals with Celiac disease consume gluten, they may suffer symptoms ranging from gastrointestinal issues to neurological problems and cancer (PDF download). According to a 2010 study, 10% of gluten-free consumers purchase gluten-free products because they or a member of their household have Celiac disease or an intolerance to gluten, wheat or other ingredients. Scientists estimate that approximately 18 million Americans have some degree of gluten sensitivity. This requires that businesses take food labeling and food handling procedures seriously.

Confusion over what is gluten and what type of special handling is required to comply with a “gluten free” label has made the universe of food labels confusing to both gluten-free consumers and manufacturers.  Food labels range from being marked “gluten-free,” “made with no gluten ingredients,” and “manufactured in a gluten-free environment.” Currently, a company can label a product as gluten-free regardless of whether the food has been tested for the presence of gluten.

McDonalds received a great deal of negative publicity in 2006 when the company admitted that the fries they had previously claimed were gluten-free, are actually prepared with an oil that uses hydrolyzed wheat bran.  After an outcry from gluten-free consumers, McDonald’s removed fries from their list of gluten-free options and began labeling them as containing the allergen wheat. Although lab results indicated that no gluten was present in the fries, McDonald’s has not relabeled the fries as gluten-free (and appears to no longer have a gluten-free list at all) possibly out of fear of more lawsuits.

The FDA has twice opened the comment period for the public to weigh in on the agency’s proposed rule on how to label food as gluten-free. The proposed rule may require, among other criteria, that food bearing the claim of gluten-free cannot contain 10 parts per million (ppm)
Continue Reading FDA Prepares to Release a Regulation on the Labeling of “Gluten-Free” Food by the End of 2012