The U.S. Food and Drug Administration (FDA) has long reacted to the public concern over trans fatty acids (also known as TFA or trans fats) found in foods as a part of Partially Hydrogenated Oils (PHOs).  FDA recently issued its final decision on how it would categorize PHOs.  Following through on an effort the FDA began in 2013, the categorization of PHOs officially changed to not generally recognized as safe (GRAS) for use in food, effectively banning trans fats.  This change in categorization now puts PHOs under the regulations that govern food additives.  Current registrations of foods containing PHOs and their labeling must eliminate PHOs by June 2018.  The FDA will allow registrants to obtain new registration of use of PHOs in foods under much stricter guidelines.

FDA’s Long Pursuit of Trans Fats – A Troubled Relationship

The FDA began its relationship with trans fats and PHOs in 2006 when the FDA required that the amount of trans fats in a food be put onto the ingredients listing of the FDA-required Nutrition Facts label.  Trans fat is listed as a part of the Saturated Fat listing.  Since trans fat is typically a percentage of Saturated Fat, trans fat could list at zero grams but still be present in the food, up to 0.5 grams of trans fat, and allow the continued use of PHOs.  This is no longer the case.

The reason PHOs became important in the food industry is that PHOs have a longer shelf life and are cheaper than other fats and oils to use in recipes.  Removal of PHOs from a food means potential changes to the Nutrition Facts label for that food.  Additionally, for an imported food currently containing PHOs, the importer will be responsible for getting its food source manufacturer to reformulate and eliminate the PHOs.

FDA’s Scope on PHOs and Trans Fat is Black and White

Using the Federal Register to issue a Declaratory Order, rather than proceeding through formal rulemaking (with the necessary notice and comment periods) the FDA has set its boundaries on what is non GRAS, on what must be eliminated, and what occurs outside these boundaries.  One boundary is that this order is for PHOs only and excludes FHOs, fully hydrogenated oils.  The Order also excludes naturally occurring trans fats, those that are not a part of PHO manufacture.  The Order clearly defines PHOs as “as those fats and oils that have been hydrogenated, but not to complete or near complete saturation, and with an iodine value (IV) greater than 4.”    The Order also provides that “Any interested party may seek food additive approval for one or more specific uses of PHOs with data demonstrating a reasonable certainty of no harm of the proposed use(s).”

FDA’s follow-up … What’s Next?

The FDA will be busy from now through June 2018 with updates to a multitude of Nutrition Fact labels, as well as new and revised food additive submissions seeking FDA’s approval to use PHOs in some “safe” manner.  For food imports containing PHOs, this means an updated recipe with an updated Nutrition Fact label, otherwise the importer may lose the ability to import.  FDA will then be able to seize imported foods and additives containing unapproved PHOS, categorizing them as adulterated, illegal imports.  With three years available to make necessary changes, violators will get little sympathy from the FDA, and may be subject to warning letters and seizure for continued non-compliance.

We can help you comply this order and other FDA regulations by reviewing the legal and regulatory basis for your updated Nutrition Facts label and determine the appropriate measures that need to be taken in order to reestablish compliance with federal laws and FDA regulations, if necessary. For more information about hiring a FDA regulatory lawyer to help you respond to this FDA Declaratory Order or how you can achieve FDA compliance, please contact us at contact@sglawfl.com.

FDA

On November 25, 2014, the U.S. Food and Drug Administration (FDA) finalized two rules requiring that calorie counts be listed on menus and menu boards in certain restaurants and vending machines (menu and vending labeling rules). The full text of the menu and vending labeling rules can be found here. The menu labeling rule applies to restaurants if they are part of a chain of 20 or more locations, doing business under the same name, and offering more or less the same menu items. The 1990 Nutrition Labeling and Education Act established nutrition labeling on most foods, but food from restaurants was not covered under this Act. Rather, the menu and vending labeling rules were mandated by the 2010 Patient Protection and Affordable Care Act.

Menu Labeling Rules

Under the new menu labeling rules, calorie counts must be displayed clearly and conspicuously, either next to the name or price of the item. In addition, the calorie count must be labeled in the same size and colored font as the associated food item. However, it must be noted that there are certain foods that are exempt from the calorie count requirements under the menu labeling rules. Condiments for general use, seasonal menu items, and daily specials are all exempt from having their calorie counts displayed. Establishments also must publish the following statement on their menus and menu boards, “2,000 calories a day is used for general nutrition advice, but calorie needs vary.” In addition to calorie counts, and upon consumer request, restaurants are required to provide written nutrition information about total calories, total fat, calories from fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrates, fiber, sugars, and protein.

Even though many state and local governments have passed their own rules and regulations regarding calorie counts, FDA suggests that these federal rules preempt any local rules on the topic, unless the local rules are identical to the federal rules. However, restaurants and other establishments not covered by the federal rules may still be subject to state and local regulations regarding calorie counts. All menu and labeling rules must be met within one year by all covered restaurant entities. For additional information, the FDA has answered many of the frequently asked questions about the new requirements, accessible here.

Vending Labeling Rules

The new rule mandating calorie counts for vending machines (“vending labeling rule”) can be found here. This rule requires vending machine operators with 20 or more vending machines must disclose calorie information for foods sold from the vending machines. Vending machine operators have two years to comply with this rule. Failure to comply with the vending labeling rules will render covered vending machine food misbranded under the Federal Food, Drug, and Cosmetic Act.

Navigating the menu and vending labeling rules can be a difficult task for any restaurant or vending machine operator.  If you would like to have your menu or website reviewed for compliance or if you think your restaurant or vending machine company is subject to these new menu and vending labeling rules and have questions about how to comply with FDA requirements, please contact us at contact@sglawfl.com.

The major changes from the old rule to the new rule are outlined here. The new rule changes the iconic “nutrition facts” panel design to emphasize parts of the label that reflect current public health concerns like obesity, diabetes, and cardiovascular disease. The new “nutrition facts” panel on labels would look like this, with the text displaying the calorie count enlarged, the percentage of daily value moved to the left side, and changing the footnote to better explain the percent daily value of certain essential nutrients.

The new rule also makes changes that reflect a better understanding of food and nutrition science. When the nutrition facts panels on labels were first introduced more then 20 years ago, the amount and quality of information regarding diet and foods were not as expansive as they are today. For example, the FDA’s new food labeling rule and updated nutrition facts panel would eliminate the “calories from fat” from the label since research has resoundingly shown that the type of fat is more important than the amount alone.

In addition, according to the FDA, the FDA’s new food labeling rule would better reflect the eating habits of the American public. The Agency notes that the rule, if implemented, will require packaged foods that are typically consumed in one sitting to have their serving size labeled as one serving, instead of more than one serving. According to the FDA, the change in serving size will help more accurately reflect consumer behavior. For an example of this new serving size rule, the FDA has published an info-graphic that illustrates this shift in consumers’ eating habits, addressing the need for changes in serving sizes.

The new rules apply to packaged foods. However, like other FDA labeling rules, the new nutrition labeling regulations will do not extend to foods served at restaurants. Food manufacturers will have two (2) years after the rule’s effective date to come into compliance with all of the new regulations. According to the FDA, the rule has a one time initial cost to the industry of $2.3 billion, but the rule is expected to bring $21 to $31 billion in cumulative benefits to consumers over the next 20 years.

As with all FDA regulations, it is important to maintain compliance with these rules to avoid adverse Agency action or other delays in the manufacturing and distribution chain. Failure to comply with FDA regulations can result in warning letters, delays in importation, injunctions, or other adverse action, which ultimately can prevent your company from doing business in the United States. Accordingly, remaining knowledgeable about new regulations and implementing measures to ensure compliance are important when dealing with FDA-regulated products.

If you have any questions about the changes to the nutrition facts panels, FDA labeling regulations or compliance with other FDA regulations, please contact us at contact@sglawfl.com

As noted by the FDA, the present action demonstrates the agency’s willingness to take enforcement action against companies that “. . . mislead consumers on the products they purchase.” Interestingly, the alleged misleading conduct was in no way related to efficacy or therapeutic claims, frequently seen as prompting enforcement actions. Rather, the deficiencies cited in the present case were limited to allegations of improper nutrient content claims. For example, and among other allegations, the FDA alleged the Company’s products bore “sugar free” claims when in fact these products contained sugar.

Under the FFDCA and accompanying FDA food labeling rules, foods must be labeled accurately or they run the risk of being deemed misbranded by the FDA. As demonstrated in the present case, failure to label food in accordance with federal law and regulations may lead to enforcement action, including costly and time-consuming halts to manufacturing and distribution processes. Accordingly, it is important to ensure that the labels of all food products that are marketed and sold in the United States are in compliance with FDA regulations.

For more information about FDA food labeling rules or how you can ensure compliance with the laws and regulations enforced by the FDA contact us at contact@sglawfl.com.