Apr 07

Food & Drug (FDA) Attorney Katherine Giannamore Interviewed on Complexities of Marketing Cosmetics

On March 31, 2015, Attorney Katherine Giannamore, of The Law Office of Katherine Giannamore, P.A., was interviewed by Ryan Nelson of “The Rose Sheet” about the challenges that companies face when marketing cosmetic products. “The Rose Sheet” is one of the industry’s premier sources for specialized, in-depth coverage and analysis of regulatory and market developments across the personal care and cosmetics industries. The full text of the article interview may be accessed here.

The article focuses on cosmetics companies’ efforts to simultaneously promote their products effectively while abiding by all applicable laws and regulations. On this blog, we have previously discussed the challenges and pitfalls associated with marketing cosmetics with drug claims. In general, the FDA advises that, first, products intended to cleanse or beautify are generally regulated as cosmetics. Second, products intended to treat or prevent disease, or affect the structure or function of the body, are drugs. Third, that some products are both cosmetics and drugs. Examples include anti-dandruff shampoos and antiperspirant-deodorants, as well as makeup with SPF (sun protection factor) numbers. These products must meet the requirements for both cosmetics and drugs, as applicable.

Many small companies choose to invest in regulatory counsel before putting their products out on the marketplace. Giannamore described her role as a regulatory counsel as, “scal[ing] [the cosmetics companies] back, pointing out what things are definitely going to get you in trouble while keeping in mind that the product has to do something.” The marketing process is usually a risk aversion exercise, seeing how much risk the company wants to take on. She further described the role of regulatory counsel as, “finding creative ways” to convey the benefits of a product without violating the Federal Food, Drug, and Cosmetic Act.

Giannamore went on to tout the benefits of hiring regulatory counsel at an early stage of the product development process. “A lot of people come to me and they already have an FDA warning letter, or they’re importing and they’ve been stopped [due to excessive claims or other issues],” said Giannamore. Many times the companies do not hire regulatory counsel, “due to lack of resources in the beginning or it just not being something that’s high on the totem pole because they’re thinking ‘We’re a small company, [the FDA] is not going to target us.’”

Hiring regulatory counsel can prove to be a sound business decision, despite the cost, particularly because of the additional expense that would be incurred if the company receives a FDA warning letter. Recently, John Bailey, of the EAS Consulting Group and formerly a director of the FDA’s cosmetics program and the chief scientist at the Personal Care Products Council, addressed the substantial costs associated with an FDA warning letter or instituting corrective measures. The FDA may require companies to re-label their products and can have production and shipments shut down in the meantime.

The actual costs of an FDA warning letter may be even greater than just the cost to re-label products and lost sales. In addition, a FDA warning letter is a public relations nightmare, according to Giannamore. “If anybody’s ever Googling you, that’s now the first thing that comes up… They’re going to say ‘Oh my God, they have a warning letter; don’t buy their product.”

We offer assistance to companies with label reviews, reviews of their marketing content, and ensuring that products comply with FDA regulations. If you would like assistance with your cosmetics products, please contact us at contact@giannamore-law.com.

KG Logo Final 150x150 Food & Drug (FDA) Attorney Katherine Giannamore Interviewed on Complexities of Marketing Cosmetics

Mar 27

FDA Warns of Marketing Cosmetics with Drug Claims

The difference between a product being marketed as a cosmetic and marketed as a drug can be a very thin line. However, the differences in regulation between the two are stark. The Federal Food Drug and Cosmetic Act (The Act) governs the regulation of drugs and cosmetic products. The Act defines a cosmetic, in part, as something designed for the, “cleansing, beautifying, promoting attractiveness, or altering the appearance [of a person].” By contrast, the Act defines a drug, in part, as a product “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease,” or “intended to affect the structure or any function of the body.” Further, when a product is considered a cosmetic, it generally does not need FDA approval before they are sold to the public. When a product is classified as a drug, then it must generally pass FDA review before it can be marketed to consumers.

FDA has recently noted that many cosmetic companies have crossed the line with claims on their advertising or packaging, causing products that would otherwise be regulated as cosmetics to be considered drugs by the Agency. Recently, the U.S. Food and Drug Administration (FDA) has been issuing warning letters to companies whose claims have gone beyond promoting the cosmetic benefits of their product and into the territory of promising outcomes typically associated with drugs, such as indicating that the product is intended to treat or prevent disease, or change the body’s structure or functions. If a company fails to comply with these rules, the FDA may take additional action beyond issuing a warning letter, which could include removal of a product from the market or other sanctions, which would likely prove costly.

Warning letters that have been issued to cosmetics manufacturers for marketing products with claims that indicate that the product is a drug can be found here. The products range from skin care creams and lotions, hair care products, and even eyelash and eyebrow treatments.

In general, the FDA advises that, first, products intended to cleanse or beautify are generally regulated as cosmetics. Second, products intended to treat or prevent disease, or affect the structure or function of the body, are drugs. Third, that some products are both cosmetics and drugs. Examples include anti-dandruff shampoos and antiperspirant-deodorants, as well as makeup with SPF (sun protection factor) numbers. These products must meet the requirements for both cosmetics and drugs, as applicable.

When promoting products in the cosmetics industry, it may be advantageous to sell the potential user on the benefits that they may experience. However, it is extremely difficult for any company to toe the line between cosmetic and drug claims. For this reason, it may be particularly helpful to have a trained professional examine the claims made regarding the product to ensure their compliance with all federal laws and FDA regulations.

We offer assistance to companies with label reviews and ensuring that products comply with FDA regulations. If you would like assistance with your cosmetics products, please contact us at contact@giannamore-law.com.

Mar 17

FDA Regulation of OTC Sunscreen Products

Have you ever wondered who ensures the safety of your sunscreen? With many people, including pregnant women and children, choosing to wear sunscreen on a daily basis throughout the summer months, it is imperative that the sunscreen on the market is safe and effective. With that in mind, on November 26, 2014, Congress enacted the Sunscreen Innovation Act to provide an alternative process for review of safety and effectiveness of nonprescription sunscreen with the U.S. Food & Drug Administration (“FDA”).

The Sunscreen Innovation Act does not relax the FDA’s scientific standards for evaluating safety and effectiveness of sunscreen ingredients. It also does not reduce the amount of adequate and relevant data on which to base FDA determinations regarding sunscreen ingredients. Rather, the regulatory process known as a time and extent application process, or “TEA”, for short, allows manufacturers to request that the FDA inspect certain active ingredients in over-the-counter (“OTC”) products. This process is mostly used when a manufacturer is able to sell an OTC product in foreign countries, but not the United States.

The first step of the TEA is for a manufacturer to prove to the FDA that it has been selling their product, with the requested active ingredient, as an OTC in one or more countries for a certain amount of time and in a manner consistent with the way it would be used in the United States. Next, the FDA will evaluate the available data on the active ingredient to determine whether it is safe for OTC use. The FDA evaluates the data submitted to determine whether an active ingredient is generally recognized as safe and effective (GRASE) for its intended use. If an ingredient is found to be GRASE, then it can be sold OTC in the United States.

Before the Act went into effect, there were 8 TEAs submitted to the FDA for review. On January 7, 2015, six (6) of the eight (8) ingredients were classified as not GRASE for use in sunscreens because more data was needed from the manufacturers to help establish the safety and effectiveness of these ingredients. On February 24, 2015, the final two (2) ingredients were also classified as not GRASE by the FDA for the same reasons as the others, in that more data was needed to demonstrate safety and effectiveness for OTC use.

As the Sunscreen Innovation Act and FDA regulation of sunscreen illustrates, even though some products may be legally sold in other countries, they may still be banned or heavily regulated in the United States. The United States has very stringent controls in place to ensure the highest quality and safety of products sold to consumers. If you are selling a product that is to be ingested or applied to the skin, it can be a difficult process to figure out which rules apply to your product and what procedures must be undertaken in order to safely get your product to market.

We offer assistance with premarket review, label reviews, and ensuring that your product complies with FDA regulations. If you would like assistance with your products, please contact us at contact@giannamore-law.com.


Feb 12

FDA Stops Company from Marketing Unapproved New Drugs

On January 30, 2015, and at the request of the U.S. Food and Drug Administration (FDA), a federal judge granted a consent decree of permanent injunction against Laclede, a U.S.-based manufacturer in connection with the marketing of unapproved new drugs. The permanent injunction prohibits Laclede from selling and distributing unapproved new drugs or misbranded drugs and devices.

According to FDA’s announcement, Laclede had a long history of violations with the FDA. In 2012, FDA inspectors found numerous violations of the Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals and other issues surrounding the marketing and sale of unapproved new drugs. As explained by FDA, the company undertook steps to correct the violations, but the Agency deemed the response ineffective. In February 2013, the FDA issued a warning letter to the company for violations of the CGMP and the Federal Food, Drug, and Cosmetic Act (FFDCA) by manufacturing and marketing both over-the-counter (OTC) and prescription drug products without an approved application (unapproved new drugs). According to the FDA Warning Letter, the Agency deemed the products to be drugs due to certain disease claims made in the Company’s marketing materials and since no approved applications were held by the Company, the products were deemed unapproved new drugs. For example, some of the claims at issue included: “Methods and composition for the treatment of vaginal diseases employing peroxide-producing enzymes and peroxidases,” “Helps Prevent The Causes Of Vaginosis, Yeast Infection and Bad Odor,” and “Probiotics: Potential to Prevent HIV and Sexually Transmitted Infections in Women.” Accordingly, the Company’s labeling was one of the major issues that led to FDA’s finding of unapproved new drugs, prompting FDA enforcement action.

On June 25, 2014, the FDA filed for a permanent injunction , as the Agency argued that the Company’s operations remained non-compliant with FDA regulations. That injunction was granted on January 30, 2015. One of the main issues here was Laclede’s failure to properly label their products. The consent decree for permanent injunction specifies that Laclede may not market any products with the words “prebiotic” or “actibiotic” on its labels or packages without first obtaining the FDA’s approval. In addition, Laclede may not market any products referencing “lubrication” without appropriate FDA approval.

In sum, properly labeling products is one of the most critical steps in the product development process. Compliance with the regulations is a must to ensure that your products stay on the shelf and that your company is not the subject of FDA enforcement action. Our firm offers comprehensive label reviews and packaging requirement assistance to help our clients ensure that their products are fully compliant with all applicable rules and regulations. If you would like assistance with your products, please contact us at contact@giannamore-law.com.

Feb 04

FDA Guides on General Wellness and Low Risk Devices

On January 20, 2015, the U.S. Food and Drug Administration (FDA) published a proposed guidance document regarding the FDA’s current position on low risk devices and general wellness products. This guidance document directs the Center for Devices and Radiological Health (CDRH) to deal with inquires from manufacturers asking whether or not their products qualify as “devices” under the Federal Food, Drug, and Cosmetic Act (FDCA). Devices are defined in section 201(h) of the FDCA as an “instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is …intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man … or intended to affect the structure or any function of the body of man….”

In the recently published FDA guidance, the FDA is instructing its staff not to consider “general wellness products” as “devices” for purposes of the FDCA, meaning that these low risk devices will not have the considerable oversight that other “devices” receive from the FDA. The proposed guidance document defines a “general wellness product” as meeting a two-factor test. First, that the products are intended for only general wellness use, as defined in this guidance. Second, that the products present a very low risk to users’ safety. However, the decision by the FDA not to regulate these products does not mean that those classes of products are safe, effective, and not misbranded for its intended use.

General Wellness Products

For a product to be classified as a general wellness product, it must meet one of two criteria:

1. It must have, “an intended use that relates to a maintaining or encouraging a general state of health or a healthy activity;” or

2. It must have an, “intended use claim that associates the role of healthy lifestyle with helping to reduce the risk or impact of                  certain chronic diseases or conditions…”

General wellness products are allowed to make claims about improving a general state of health, but they must not make any references to diseases or conditions. General wellness products are only allowed to make references to diseases or conditions when it is well understood that healthy lifestyle choices may reduce the risk or impact of a chronic disease or medical condition. This means that generally accepted science has proven that healthy lifestyle choices may play an important role in health outcomes.

Low Risk Devices

If a product presents an inherent risk to the safety of the user, then it is not exempted by this guidance document. If a product does any of the following four things, then it is not a low risk product for purposes of this guidance document and is not considered a general wellness product if:

1. the product is invasive;

2. the low risk device involves an intervention or technology that may pose a risk to a user’s safety if device controls are not                    applied, such as risks from lasers, radiation exposure, or implants;

3. it raises novel questions of usability, or

4. if the low risk device raises questions of biocompatibility.

This guidance document is an interesting stance from the FDA insomuch as the FDA is taking a self-limiting position by essentially saying that the Agency should not be regulating these devices. Rarely does the FDA take such a self-limiting stance on issues of product regulation. However, just because the FDA is not regulating these General Wellness products, it does not mean that they are completely unregulated. The Consumer Product Safety Commission (CPSC) may also have the authority to decide whether a general wellness product is a consumer product under CPSC’s authority vested in it by the Consumer Product Safety Act. Accordingly, how this guidance document and federal law will be applied in practice remains to be seen.

A guidance document serves as the Agency’s official stance on a subject. Further, it does not create any legally enforceable duties upon the Agency. It solely guides the decision makers within an agency to uniformly apply the specified laws and regulations. This proposed guidance document is open to public comment before it becomes final. Currently, electronic comments can be sent to the FDA at this website. The public comment period is open for 90 days, and then the Agency will review all of the comments that are received and will finalize the guidance document.

Navigating the web of regulations and regulatory bodies can be a daunting task. When selling or distributing a product, a company must be absolutely certain that they are meeting all regulatory requirements or risk enforcement action. If you think your product may be affected by the new guidance document and want to be sure your claims and labeling are in compliance or see how you may be regulated by FDA, our office offers reviews of product labels and health claims. If you have any questions about the new guidance document or whether your product is considered a “device” please contact us at contact@giannamore-law.com.

Jan 28

Court Issues Injunction after FDA Warning Letter Issues Persist

On January 16th 2015, a California dietary supplement manufacturer, Health One Pharmaceuticals, Inc., was ordered to stop sales of its products until the company meets certain U.S. Food & Drug Administration (“FDA”) regulations and mandated standards (Current Good Manufacturing Practices or “CGMPs”). According to the FDA, the steps taken by the manufacturer in response to an FDA warning letter and FDA inspections did not bring the facility back into compliance with the CGMPs, prompting FDA to move forward with the action for injunction. In the case against the company, the judge signed a consent decree of permanent injunction, which requires Health One to recall and destroy all dietary supplements that the company manufactured, prepared, packed, labeled, held, or distributed between September 1, 2011 and January 15, 2015. Health One is a private label and contract manufacturer of tablets, pills, and powders. Their products include herbal formulations, vitamins, minerals, prebiotics, probiotics, effervescent and meal replacement products.

The consent decree and permanent injunction stemmed from a FDA warning letter issued to Health One in March of 2012, which laid out serious violations of FDA regulations rules. The FDA Warning Letter can be read in its entirety here. The FDA inspected Health One’s manufacturing facility in September 2011 and found serious violations of the FDA’s Current Good Manufacturing Practice (“CGMP”) for dietary supplements. Some of the violations that Health One received included failure to perform tests to verify the identity of dietary ingredients used to manufacture the supplements, failure to establish appropriate manufacturing controls, and failure to maintain, clean and sanitize equipment. Further follow-up inspections revealed that Health One failed to correct many of the manufacturing violations initially cited in the FDA warning letter. Since Health One was in violation of the CGMP, its products were considered “adulterated” by the FDA under the Federal Food, Drug, and Cosmetic Act.

There are CGMPs for various industries, including foods, dietary supplements, drugs and medical devices. To help businesses comply with FDA regulations and manufacturing requirements and explain the rules for industry, the FDA has issued guidance documents for many industries, which can be found here.

Compliance with the FDA regulations is an increasingly difficult task for businesses and failure to comply can spell disaster for companies. In order to avoid recalls and permanent injunctions, it is very important to comply with the CGMP’s and respond appropriately to FDA warning letters. If you have any questions regarding compliance with the various CGMP’s or the Federal Food, Drug, and Cosmetic Act, please do not hesitate to contact us at contact@giannamore-law.com.KG Logo Final 150x150 Court Issues Injunction after FDA Warning Letter Issues Persist

Jan 05

Overview of FDA’s Final Menu and Vending Labeling Rules

Menu and Vending Labeling Rules

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@giannamore-law.com.

Dec 01

FDA HACCP Enforcement Sandwiches Food Company between a Rock and a Hard Place

On November 21, 2014, the U.S. Food & Drug Administration (“FDA”) filed for a permanent injunction in the Eastern District of Michigan against Scotty’s Incorporated, a manufacturer of ready-to-eat sandwiches. The FDA alleges that Scotty’s violated the Hazard Analysis and Critical Control Points (HACCP) food safety management system, which according to FDA must be followed under federal law.

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@giannamore-law.com.FDA Attorney 150x150 FDA HACCP Enforcement Sandwiches Food Company between a Rock and a Hard Place

Nov 13

USDA Organic Labeling

The United States Department of Agriculture (USDA) oversees the National Organic Program and organic labeling in the United States. The National Organic Program is a regulatory program housed within USDA Agricultural Marketing Service, which sets standards for organically produced agricultural products. These standards do not address food safety or nutrition, as these issues are within the regulatory oversight of FDA or other USDA programs. The statutes under which the National Organic Program operates are found here.

When a company wants to use organic labeling or label a product in a way that promotes the use of to organic ingredients, they may use the phrase, “made with organic ____” in labeling if the product meets the requirements set out in the statutes. First, the USDA must certify operations that grow, handle, or process organic products as organic. In other words, the producer of the organic material must be certified as “organic” by the USDA. Subpart E of the National Organic Program governs organic certification.

Foods that are labeled with the “Made with organic” language must comply with strict requirements. First, they contain at least 70% organic ingredients, 7 CFR § 205.301(c). As opposed to organic labeled foods, this means that a “Made with organic ____” product may contain a maximum of 30% nonorganic ingredients, as set forth in the National List of Allowed and Prohibited Products, codified at 7 CFR § 205.605.  Further, these types of products must not contain any ingredient made using any of the prohibited methods as listed in 7 CFR § 205.105.

Products are only allowed to list three (3) ingredients, food groups, or combination of ingredients and food groups after the “Made with organic ____” statement. A generic “Made with organic ingredients” statement is prohibited. There are also many other restrictions on the types of labeling allowed with organic ingredients. For example, when a product uses organic and inorganic versions of the same ingredient, the ingredients must be listed separately on the ingredients list. Further, specific ingredients cannot have their own “percent organic” label. A label that includes “100% organic sugar” is in violation of the National Organic Program. For more examples of prohibited labels and how to fix labeling problems, the USDA has produced a guidance document, or explanatory document setting forth the Agency’s current policy on the topic.

If a company wants to include a food group-specific label claim on their “Made with organic” statement, the only food groups that can be listed are beans, fish, fruits, grains, herbs, meats, nuts, oils, poultry, seeds, spices, sweeteners, vegetables, or processed milk. All other food groups are prohibited to be listed as “Made with organic” as described in 7 CFR § 205.304. In addition, these label claims must be truthful. As with other ingredients, if it is going to be included as a “Made with organic” ingredient, all raw and processed forms of that ingredient must be certified organic.

The world of organic labeling is ever-changing and has very specific requirements. Labeling your product is a very complex task and doing so incorrectly can result in penalties ranging from suspension to rejection of the company’s organic status. Knowingly selling a product labeled as organic or with some form of organic labeling that does not comply with the organic labeling regulations can result in fines of up to $11,000 per violation. For questions regarding organic labeling and for inquiries about label reviews of your product labels, please contact us at contact@giannamore-law.com.

FDA Attorney 150x150 USDA Organic Labeling

Oct 31

FDA Food Allergen Labeling

When consumers with food allergies are purchasing food products, they normally examine the food labels to make sure a product does not contain any ingredients that would cause them to have an adverse reaction. Milk, eggs, fish, shellfish, nuts, wheat, peanuts, and soybeans are all common ingredients considered “major food allergens” that can potentially cause life-threatening consequences for consumers with allergies. The U.S. Food and Drug Administration notes that each year in the United States, food allergies cause 30,000 visits to the emergency room, 2,000 hospitalizations, and 150 deaths. Because of these health concerns, food allergen labeling has emerged as an important area in federal regulation.

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@giannamore-law.com.

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