• 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.

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

Importers introducing cosmetic products into the United States must be mindful of FDA regulations, which can present a barrier to market entry if the appropriate steps are not taken to ensure compliance. The U.S. Food & Drug Administration (“FDA”) works in conjunction with the U.S. Customs and Border Protection (CBP) to monitor cosmetic products at the time of entry. Noncompliance with FDA regulations can result in a shipment being refused entry into the United States or a product being recalled from the market after entry.

However, one may mistakenly assume that cosmetic products are subjected to the same FDA scrutiny as foods or medical device products. In fact, this is not the case; instead, the FDA’s focus on the cosmetics industry differs from the regulation of other FDA-regulated products. Unlike the FDA’s regulation of many other FDA-regulated, cosmetic products and their ingredients (with the exception of color additives) do not require FDA premarket approval and registration or approval requirements are largely inapplicable.

Cosmetic Products and Import Alerts

Due to the high volume of cosmetics imported into the domestic market, as a practical matter, not all cosmetics are inspected or sampled upon entry into the country. Rather than implement blanket inspections, the FDA focuses its inspection efforts on potentially risk-laden products in addition to conducting inspections of randomly-sampled products. As part of these targeted efforts, the FDA issues Import Alerts, which provide a risk monitoring system for the FDA and a signal to importers on the agencies regulatory focus. According to the FDA, Import Alerts for cosmetic products focus on cosmetic products marketed with therapeutic claims, those that are adulterated with microbial contamination, and products which fail to meet FDA requirements for color additives. As explained below, issues surrounding color additives present one of the more complex and important regulatory issues in the cosmetics industry.

Cosmetic Products and Color Additives

Under the authority of the Federal Food, Drug and Cosmetic Act (“FFDCA”), cosmetic products containing color additives are subject to a strict system of approval prior to entering the market. Certain color additives must be batch certified by FDA if they are to be used in cosmetics. Although some colors are exempt from batch certification, these colors are considered artificial colors, and when used in cosmetics or other FDA-regulated products, they must comply with the identity, specifications, uses, restrictions, and labeling requirements stated in the regulations.

Further, all color additives must meet the requirements for identity and specifications. Color additives may be used only for the intended uses stated in the regulations that pertain to them. The regulations also specify other restrictions for certain colors, such as the maximum permissible concentration in the finished product. With the exception of coal-tar hair dyes, failure to meet U.S. color additive requirements causes a cosmetic to be adulterated which may subject the product to removal from the market or detention. Accordingly, even when marketing cosmetics, there are important considerations from a FDA regulatory perspective, and compliance with these regulations will ensure smooth importation and marketing of cosmetics.

Navigating the web of regulations governing cosmetic products can be a daunting task. If you have any questions about FDA regulations or how these regulations relate to the marketing of a cosmetics products, 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

FDA Imports: Food Imports

All food that is imported into the United States has to meet the same requirements as food that is domestically produced, or manufactured within the United States. This means that imported food has to comply with The Federal Food, Drug, and Cosmetic Act (FD&C Act), The Fair Packaging and Labeling Act, and The Nutrition Labeling and Education Act (NLEA), which amended the FD&C Act. These requirements include ensuring all ingredients are permitted for use in foods and that the product labels comply with federal regulations. All imported foods are inspected when offered for import or entry into the United States.

Recently, food security has become a larger national priority, which has resulted in increase regulation in the area of FDA imports. In particular, Congress enacted The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act), which requires food manufacturers and importers to: (1) register with FDA every two years and (2) submit prior notice of the imported food, which means that the importer must alert the FDA to what they are planning on importing before the shipment is offered for import. The prior notice requirement is waived a few distinct circumstances:

1. The food is brought into the United States by an individual for personal consumption;

2. Food that is imported and then exported without leaving the port of arrival;

3. Personal gifts sent from an individual in a foreign country to an individual in the United States;

4. Diplomatic gifts to an embassy in the United States, and

5. Food products that are the subject of exclusive jurisdiction of the U.S Department of Agriculture, such as meat, poultry, and eggs.

Additionally, Under the Food Safety and Modernization Act (FSMA) of 2010, if the imported food was refused entry in another country, the prior notice must also identify the other countries where the food was refused entry.

FDA Imports: Cosmetic Imports

Cosmetics imported into the United States must also comply with the same laws and regulations as those produced in the United States. Cosmetic products cannot have any prohibited ingredients and must be safe for their intended uses. Similar to foods, ingredients and labeling must be compliant with FDA regulations. Companies importing cosmetics are not required to register with the FDA but are encouraged to do so through the Voluntary Cosmetic Registration Program.

In addition to the above concerns, importers of cosmetics must be aware of other laws that could possibly govern their products. Many times, other countries have different definitions of drugs and cosmetics than the United States uses. For example, in the United States, sunscreen is regulated as a drug, while in other countries; it is regulated as a cosmetic product. Also, a product can be both a cosmetic and a drug. Importers should be aware of the different classifications and requirements for their products.

Navigating the maze of requirements for importing food products and cosmetics can be a complex task and there are several points to consider when dealing with FDA imports. If you are importing food products or cosmetics into the United States, compliance with the FDA regulations applicable to FDA imports is important. If you have any questions about compliance with the FDA import regulations and programs, please contact us at contact@sglawfl.com.

The undeclared substances, Sibutramine Hydrochloride (sibutramine), an active ingredient in the obesity drug Meridia (pulled from the United States market in December 2010 based on increased risk for stroke and heart attack in users), and Phenolphthalein, an inactive ingredient linked to cancer risk, were found in multiple test samples from various distributors. The FDA warning letter was issued to manufacturers of Zi Xiu Tang Bee Pollen, threatening that seizure of product and criminal prosecution measures would be taken should they refuse to comply with proper labeling under FDA guidelines. Despite this warning, manufacturers and distributors of Zi Xiu Tang Bee Pollen continued its marketing and labeling practices, resulting in the FDA issuing an Import Alert to ban the product’s entry into the US market. Further action, if warranted by the FDA, may include the issuance of additional warning letters to the company and heightened enforcement action, including product seizures, injunctions and possible criminal charges.

The problem of undeclared ingredients in weight loss supplements and other products, drug ingredients or otherwise, is taken very seriously by the FDA. As evidenced by the February 14, 2013 raid of Globe All Wellness, LLC by U.S. Marshals acting on behalf of the FDA, the measures taken to uphold the requirements of the Federal Food, Drug and Cosmetic Act (FFDCA) can be severe. FDA warning letters, product recalls and seizures, and ultimately criminal prosecution can occur where noncompliance with these requirements is found. Companies, including manufacturers, or distributors of products that have received a warning letters from the FDA should take these issues seriously and take steps towards achieving compliance in order to avoid heightened scrutiny and enforcement by the FDA.

If you have any questions about the FDA warning letters and how you can maintain compliance with regulations pertaining to the labeling and marketing of these products, please contact us at contact@sglawfl.com.

Similar to tobacco products previously regulated by the FDA, the new regulations would require product manufacturers and marketers, including marketers of e-cigarettes, to follow certain guidelines, such as the following:

• FDA registration and reporting of product information
• Certain new tobacco products can only be marketed after a full FDA review
• Free samples cannot be distributed
• Only scientifically proven, direct claims of a decreased health risk, i.e., “smoking e-cigarettes is safer than traditional cigarettes”,  can be made where the FDA is able to verify that the evidence meets a certain level of scientific support

Additionally, the new proposed rules will include certain restrictions on newly-regulated tobacco related products, including e-cigarettes, that apply to marketing and sale of previously-regulated tobacco products, such as the following:

• Product packaging must list health warnings
• Identification and minimum age requirements in order to prevent underage purchases
• Products cannot be sold in vending machines unless the machine is located in a facility does not allow underage youths

The full text of the proposed regulations may be accessed here.

Although new tobacco products like e-cigarettes are not subject to current, final regulations pertaining to other tobacco products, the agency is working hard to gain control over these items, as illustrated through the proposed rule. If and when the regulations pertaining to e-cigarettes and other new tobacco products are finalized, importers and marketers of these products will be required to comply with the various requirements in order to ensure that their products may be marketed in a manner consistent with federal law. Accordingly, product registration and changes in marketing, including revisions to current labeling for e-cigarettes and the like, may be necessary in order to continue doing business in the United States.

If you have any questions about the FDA’s proposed tobacco product regulations or how you can maintain compliance with FDA regulations, please contact us at contact@sglawfl.com.

The Guidance sets forth the Agency’s current thinking pertaining to honey labeling. In particular, the FDA notes the proper uses of the term “honey” in labeling and notes that labelers may state the name of the source of honey, such as plant or blossom, depending on whether this source is the chief floral source of the honey. More information about the labeling of honey can be found here.

In addition to honey labeling issues, the FDA monitors the importation of honey and honey products to check for adulteration caused by the addition of corn sugars and sugar cane. Under sections 402(b)(1) through 402(b)(4) of the FFDCA, a food is considered to be adulterated if an important component has been withheld from a food, any element has been fully or partially replaced or a component has been added to the food in order to inflate the weight or size, decrease quality or to make it seem superior in quality. Accordingly, products labeled as honey that contain added corn sugars, sugar cane or other substances would not be released into American distribution until the FDA finds that the honey has not been adulterated.

In sum, in order to import honey products without issue, industry is responsible for ensuring honey labeling is compliant with regulations and that honey products, as formulated, are not otherwise found to be adulterated under federal law. If you need assistance with honey labeling, importing or maintaining compliance with the laws and regulations enforced by the FDA, contact us at contact@sglawfl.com.

Pursuant to section 801(m) of the Federal Food, Drug, and Cosmetic Act (FDCA), as amended by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, an article of food imported or offered for export may be refused admission into the United States if adequate prior notice has not been provided. 21 CFR §1.281 explains the information that must be submitted in a prior notice. The 2011 IFR and final rule now require a party submitting a prior notice to report the name of any country to which an article of food has been refused entry. While, the FDA currently requires that only the identity of the country and not the reasons for the refusal be submitted, other information could be required on a case-by-case basis. As noted in the preamble to the final rule, the FDA, after reviewing the prior notice, may request that the submitter provide additional information.

According to the FDA, only refusals of entry or admission that are based on food safety reasons must be reported in a prior notice. The agency is primarily concerned with identifying foods that present a health risk to consumers. However, as we have seen with most regulatory authority and interpretations thereunder, “public health” has been interpreted very broadly. In sum, when there is a violation of the prior notice regulations, the FDA will take the totality of the circumstances into account in deciding whether to enforce the violation. For example, it will look at the severity of the violation and any previous violations, particularly if they were similar.

You can read more about the FDA’s guidelines for the prior notice of imported foods here. If you have any questions about prior notice requirements or how a FDA regulatory attorney can help you comply with the FDCA and accompanying FDA regulations, please contact us at: contact@sglawfl.com.

The FDA warned of several deficiencies it found with the product. In particular, the FDA noted that the label, which appears solely in Spanish, identifies the product for use in the treatment of various diseases and conditions, including arthritis, muscle pain, osteoporosis, and bone cancer, among others. Under FDA regulations, while dietary supplements may contain structure-function claims, statements that a product may be used to treat a disease or condition may cause a product to be regulated as a drug.

In the case of Reumofan Plus, the deficiencies the FDA allegedly discovered go far beyond simple marketing issues. Rather, the FDA’s alert also discusses how the product was discovered to contain diclofenac sodium and methocarbamol. Diclofenac sodium is used as a prescription non-steroidal anti-inflammatory drug (“NSAID”), particularly the drug Voltaren. Methocarbamol is a prescription muscle relaxant, i.e., the drugs Robaxin and Rabdolax. To make matters worse, the FDA notes that the product has also been the subject of several adverse events. Judging from the Alert, it appears that Reumofan Plus and the manufacturer thereof, Riger Naturals, have run the gamut with the types of regulatory violations alleged by the FDA.