Under the Federal Food, Drug and Cosmetic Act (“the Act”), products that are promoted for the prevention, treatment and/or cure of diseases are deemed drug products. 21 USC 321(g). This means that products that may otherwise be marketed as dietary supplements, including those that have “Supplement Facts” labeling and those containing only botanicals and vitamins, would be classified as drugs if they are marketed for disease treatment. Accordingly, it is important to ensure that dietary supplements are properly marketed in order to avoid classification as drug products and avoid FDA action.

When developing a product it is important to ensure that all claims made in labeling comply with federal law and regulations enforced by the FDA. If you have any questions about how you can market products in compliance with the laws and regulations enforced by the FDA, please contact us at contact@sglawfl.com.

• 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.

Cockroach Killer or Food Ingredient?

Linalool is considered Generally Recognized as Safe (GRAS) for use in human foods as a synthetic flavoring substance by the FDA under 21 C.F.R. § 182.60. This means that linalool can be used in foods and is considered safe by the Agency. In fact, linalool has widespread application from foods to cosmetics and other FDA-regulated products.

The ingredient’s alleged use in insecticide does not in itself make the ingredient dangerous or inappropriate for use in food. If it did, then even water, which has numerous applications outside of food uses, including insecticides, would be considered dangerous. In short, it’s a good headline and it would probably make any company wish they had already entered into a settlement, but that does not mean the ingredient is unsafe.

But is it “Natural”?

Although there is no current FDA regulation defining “natural”, the Agency has stated that it considers the term to mean nothing artificial – which isn’t saying much. The Plaintiffs best argument is probably that the GRAS regulation specifically notes that linalool is synthetic, which may well disqualify it from use with “all natural” claims. However, with no actual regulation to violate, the case may be somewhat more complex. For more information on “Natural” claims and FDA regulations, visit our previous article here.

In sum, La Croix is faced with a difficult situation, as the intricacies of food and drug law are not well understood leaving emotional headlines like “La Croix Sued Over Use of Ingredient Found in Cockroach Insecticide” to dominate the conversation. If you have any questions about labeling or ingredient regulations, please feel free to contact us at contact@sglawfl.com.

FDA Standard of Identity and Dairy Labeling

Under 21 CFR 131.110, the FDA defines “milk” 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 for product labeling, a product labeled as “milk” must have animal origin, i.e., be actual dairy. According to dairy industry groups, who support the current standards of identity, labeling almond milk or soy milk as milk is misleading because the product is plant-based and was not derived from a dairy animal. In addition to milk, the regulations pertaining to naming of dairy affects other dairy-based products, like those labeled as cheese and yogurt.

Only time will tell whether the standards of identity for dairy products will be modernized by FDA. 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. 

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 noted that there are no legally marketed over-the-counter (OTC) drugs that prevent nor cure the flu. However, there are legal OTC products that can reduce fever, relieve muscle aches, congestion, and other symptoms associated with the flu. FDA warns that dietary supplements labeled with flu treatments claims would be regulated as drugs by the Agency as products that are intended to treat, prevent, or cure diseases/conditions are deemed drugs under federal law. Accordingly, marketers of products with these claims should be very careful as they may be in violation of FDA laws and regulations.

In sum, when developing a product, it is important to ensure that all claims made in labeling comply with federal law and regulations enforced by the FDA. If you have any questions about how you can market products in 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

FDA Untitled Letters: Why It Matters?

Many businesses may be well versed when it comes to handling FDA Warning Letters, but when it comes to FDA Untitled Letters recipients of Untitled Letters may not fully understand how to respond. Accordingly, there are a few things to keep in mind once a FDA Untitled Letter is received. First, an Untitled Letter should not go unanswered, as the terms of the Letter require response, and a comprehensive response thereto could potentially save a business from being issued a Warning Letter or other enforcement action.

Differences between FDA Warning Letters and FDA Untitled Letters

1. Warning Letters describe alleged violations with both online marketing materials and print marketing materials, as well as product labels. Conversely, Untitled Letters appear to be focused solely on online marketing materials.

2. Untitled Letters are typically not published on the FDA’s website, unlike FDA Warning Letters, which are routinely published on the FDA website. However, it is important to note that although the Agency does not automatically post FDA Untitled Letters, non-response may trigger publication, reinforcing the importance of a response to FDA Untitled Letters adequately and promptly.

Assistance with FDA Untitled Letters

If you have received an Untitled Letter from the FDA it is vital that you do not disregard the letter. In particular, the receipt of a FDA Untitled Letter may signal an additional chance to resolve the issues cited by the FDA before risking receipt and publication of a FDA Warning Letter. If you are unsure what a FDA Untitled Letter means and what action must be taken, our Firm is available to help you with this process. Whether it be FDA Warning Letters or FDA Untitled Letter we can help you develop and implement necessary, corrective measures before your products or business face consequences. If you are in need of assistance 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.