• Milk;
• eggs;
• fish;
• crustacean shellfish;
• tree nuts;
• peanuts;
• wheat, and
• soy.

Food Allergen Labeling

Under FALCPA and accompanying FDA regulations, major allergens must be declared in the labeling of all food products (including dietary supplements) sold in the United States. If the major allergens are not appropriately declared, companies face the possibility of detention/refusal, warning letters, and (because allergens invoke serious health risks to consumers) even recalls. Accordingly, it is important for marketers to stay up-to-date with current labeling regulations to avoid costly mistakes.

Interestingly, although the major food allergen list in the United States has some overlap with those food ingredients considered major allergens abroad, there are some distinctions. For example, in the European Union, sesame seeds are already deemed a common allergen, as are celery, mustard and other items not named on the major allergen list in the United States. Thus, as with other labeling components, it is important that importers and marketers of FDA-regulated food products are knowledgeable of FDA food labeling requirements since there are key differences for products sold in the U.S. market.

For more information about food regulations or our services, please visit us at Giannamore-law.com.

Although the Food Safety Modernization Act (FSMA provides the U.S. Food & Drug Administration (FDA) with the authority to issue mandatory recalls for unsafe food products, most companies issue voluntarily recalls when a mislabeling or adulteration issue arises. One reason that we continue to see voluntary recalls is that the FDA must undertake certain procedures before ordering a mandatory recall.

In order to issue a mandatory recall, the FDA must first determine that the criteria for mandatory recall has been met. Criteria for a mandatory recall may be that the food is adulterated under Section 402 of the Federal Food Drug & Cosmetic Act (FDCA). Adulteration occurs when the food (including dietary supplements) contains poisonous or deleterious substances or a substance that is otherwise unfit for food.  A food may be misbranded under the FDCA when the product labeling does not meet federally mandated requirements. For mandatory recall authority, misbranding under Section 403(w) of the FDCA would be where required major allergens are not displayed in product labeling, thus creating risk to consumers who rely on allergen warnings when making food choices.

Once mandatory recall authority has been established, the FDA must then give the company an opportunity to issue a voluntary recall. If the company still does not undertake a voluntary recall, despite FDA correspondence indicating that the criteria for recall has been met, then FDA can issue a mandatory recall. Because FDA must follow this protocol, it is unlikely that FDA’s exercise of mandatory recall authority will ever become the rule rather than the exception.

If you have any questions about FDA regulation or how you can establish and maintain compliance with the laws and regulations enforced by the FDA, please contact us at contact@sglawfl.com.

FDA Standards of Identity and Dairy Labeling

The term “milk” is defined by the FDA under 21 CFR 131.110 as “the lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cow.” Thus, in order to meet standard of identity requirements, a product labeled as “milk” must have animal origin. According to industry groups backing enforcement of this distinction, labeling almond milk as milk is misleading because almond milk is plant-based and was not derived from a dairy animal. Accordingly, the Bill aims to restrict the ability of beverages made from plant foods from using the term “milk” on their labels. Additionally, enforcement of these regulations pertaining to naming of dairy affects other dairy-based products, like those labeled as cheese and yogurt.

In sum, the Spending Bill directs the FDA to strictly enforce labeling standards of what can be labeled as “milk”. Per the terms of the Bill, FDA has 180 days to release a guidance document detailing how the dairy labeling standards will be implemented and enforced. If you have any questions about FDA regulations or how you can bring your labels into compliance with FDA regulations, please contact us at contact@sglawfl.com. 

Honey is defined as a “thick, sweet, syrupy substance that bees make as food from the nectar of plants or secretions of living parts of plants and store in honeycombs.” If a food contains only honey, then it must be named “honey” and may also include the source of the honey.  Since a honey is a single-ingredient food, it is generally not necessary to include an ingredient statement on the label. If a food contains honey and a sweetener or honey and a flavor ingredient, then it cannot be called “honey”. Rather, the food product would need to bear a standard of identity (again, not “honey”) and bear an ingredient list on the information panel of the label.

FDA Labeling and Regulations for Honey Products

Under federal law, if a food product is labeled “honey” but contains flavor or other ingredients, the FDA would consider this product to be misbranded and/or adulterated. 21 CFR 101.4(a)(1) and 403(i)(2). Additionally, the FDA has an import alert for violative honey products and affected products would be detained until the product is deemed not adulterated or misbranded. Import Alert 36-01.

In sum, whether a product has compliant FDA labeling and is properly marketed as “honey” or a honey-related product with additional ingredients will depend on what ingredients, if any, are added to the honey. Thus, when developing a product to bring to market or importing a product into the United States, it is important to be sure that FDA labeling requirements are considered to ensure that the product is properly regulated.

If you have any questions about the proper FDA labeling of “honey” and honey products or how you can market products in compliance with the laws and regulations enforced by the FDA, please contact us at contact@sglawfl.com

But what does the FDA think about “natural” food labeling, and what is legally required to appear on food labels?

While FDA regulations currently do not define “natural” for use in food labeling, the Agency has maintained a longstanding policy concerning the use of “natural” food labeling. FDA’s nonbinding guidance on this subject defines “natural” as “nothing artificial or synthetic (including all color additives regardless of source) has been included in or has been added to, food that would not normally be expected to be in the food.” Although this policy touches on the qualitative aspects of food, this policy does not address production methods and food processing or manufacturing methods. Further, the FDA also does not presently consider in its non-binding guidance whether the term “natural” should describe any nutritional or another health benefit derived from such foods.

Currently, importers and marketers of FDA regulated foods are open to use “natural” claims in labeling so long as the foods meet this minimal standard. However, based on public comments urging FDA to define “natural” for use in food labeling, changes may be on the horizon.

For more information about hiring a FDA regulatory attorney to help you develop FDA-compliant labeling or how you can achieve FDA compliance, please contact us at contact@sglawfl.com.

The FDA also notes that this recent move is driven by recent private litigation surrounding the term “natural” in which some federal courts requested administrative determinations from the FDA as to the propriety of labeling of food products containing genetically engineered ingredients or high fructose corn syrup as “natural.”

While FDA regulations presently do not offer a formal definition of the term “natural,” the Agency has maintained a longstanding policy concerning the use of “natural” in human food labeling. FDA’s nonbinding guidance on this subject defines “natural” as “nothing artificial or synthetic (including all color additives regardless of source) has been included in or has been added to, food that would not normally be expected to be in the food.”  Although this policy touches on the qualitative aspects of food, this policy does not address production methods and food processing or manufacturing methods. Further, the FDA also does not presently consider in its non-binding guidance whether the term “natural” should describe any nutritional or another health benefit derived from such foods.

As part of the public comment process the FDA requests information on whether it is appropriate to define the term “natural;” suggestions as to how the agency should define “natural,” and the term’s appropriate use of the term on food labels. The FDA is accepting public comments through February 10, 2016.

For more information about hiring a FDA regulatory lawyer to help you develop FDA-compliant labeling or how you can achieve FDA compliance, please contact us at contact@sglawfl.com.

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.

Scotty’s had previously received a Warning Letter in 2009 for failing to have adequate processes and controls in place to minimize the risk of contamination and for failing to have a written HACCP plan for the tuna salad sandwiches prepared at the business. Then, in 2010 and 2014, FDA inspectors documented what the Agency alleged to be the company’s failure to manufacture, package and store food under conditions and controls necessary to minimize the potential for growth of microorganisms and contamination. According to the FDA, the Company failed to heed the Agency’s prior warning and was still not in compliance with HACCP regulations.

There have been no reported complaints from the public or reports of illnesses from the sandwiches from Scotty’s Incorporated, which does business as Bruce Enterprises and Bruce’s Fresh Products.

FDA HACCP Regulations

HACCP is a food safety system which encompasses all facets of food production, from manufacturing, to distribution, to consumption of the finished product. HACCP plans analyze food safety issues resulting from biological, chemical, and physical hazards. The HACCP management system relies on the following seven principles:

1) Conducting a hazard analysis;

2) Determining the critical control points (CCPs);

3) Establishing critical limits;

4) Establishing monitoring procedures;

5) Establishing corrective actions;

6) Establishing verification procedures, and

7) Establishing record-keeping and documentation procedures.

Appendix C describes the questions that a typical HACCP team will need to consider when creating a plan. A typical plan includes hazard analysis, decision-making trees, and verification processes as well as procedures for record keeping.

Currently, there are generic HACCPs for the dairy, juice, seafood, and retail and foodservice industries. However, the FDA encourages each food producer to assemble an HACCP team to devise a strategy to make an HACCP plan. Each HACCP plan will vary, depending on the industry, product, and specific process utilized by each individual company.

In addition, it is important to note that there are various exemptions to the HACCP requirements. For example, under the juice HACCP regulations, a person who makes and sells apple cider or other fresh juices directly to consumers may not be required to have a HACCP plan or otherwise comply with HACCP requirements. However, a person who sells their juices to a store which will then sell to customers is required to have an HACCP plan.

Determining whether an exemption to HACCP requirements exists is a complex task. Due to the number of different requirements, such as the retail juice exception, voluntary HACCP rules for food service industries, and requirements for pasteurized milk, it is important to ensure that you are complying with all applicable regulations prior to beginning operations. For questions regarding HACCP plans and compliance with FDA regulations, please contact us at contact@sglawfl.com.

Every year, countless food product recalls are caused by “undeclared allergens”, which are major allergens not listed on product labels. A list of all current recalls, including those that were recalled due to food allergen labeling issues, can be found here. For example, The U.S. Food and Drug Administration (FDA) published notification of a recent recall of vegan gingersnap cookies, which were removed them from shelves when it was found that they contained tree nuts, milk, soy, and egg, none of which were listed on the product labels and therefore the products were not compliant with food allergen labeling regulations.

Federal law requires that food producers and distributors include allergy information on their labels. The Food Allergen Labeling And Consumer Protection Act of 2004 (FALCPA) governs the disclosure of certain allergens on food labels. The FALCPA only requires disclosure of 8 major food groups on labels, although there are over 160 foods that produce allergies in humans. However, the FDA has found that over 90% of food allergies are caused by the following 8 major food groups: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans. In addition, on August 5, 2013, the FDA issued a final rule regarding the labeling of “gluten free” foods, which as also authorized by FALCPA as part of the laws on food allergen labeling. As of August 2014, the FDA has started to enforce this rule, just as they do with the other 8 major food allergens.

The Food Allergen Labeling and Consumer Protection Act requires that food products be labeled in very specific ways. There are two ways to label foods containing allergens. First, the common name of the allergen can be placed in the ingredient statement. Second, the food producer can include a “contains” statement, which includes the food source from which the major food allergen is derived. For example, the food label should look like this.

The FALCPA does not apply to “cross-contact” situations that may arise during manufacturing, such as shared equipment or processing lines. Food producers are encouraged to use food allergen advisory statements, such as “may contain [allergen]” or “produced in a facility that also produces [allergen].”

When a company violates the food allergen labeling requirements of the FALCPA, they may be subject to civil sanctions, criminal penalties, or both under the Federal Food, Drug, and Cosmetic Act. FDA may also request seizure of food products where the label of the product does not conform to FALCPA’s requirements. To avoid these heightened enforcement measures, many companies will opt to recall their products, as shown above.

Labeling your product requires intricate knowledge of many different statutes and regulations, such as FALCPA, the Federal Food, Drug, and Cosmetic Act, and the Food Safety Modernization Act (FSMA). We have previously blogged about the FSMA, food labeling, and the penalties for not complying with FDA regulations. For questions regarding food labeling and for inquiries about label reviews of your  product labels, please contact us at contact@sglawfl.com.