With the passage of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), congress has directed the FDA to develop a program for the submission of both cosmetic facility registrations and product listings. Until the FDA has readied its submission process, we can only assume that the procedure will be similar to that currently applicable to OTC drug products, where manufacturers are required to register their facilities and list their products, as well as comply with good manufacturing practices—which, in the case of cosmetics, are to be determined by the FDA through the rulemaking process. In addition, MoCRA has mandated additions to the labeling regulations (particularly for allergens) and testing requirements. Needless to say, a lot of changes are on the way in the cosmetics industry, and it is important for companies to stay abreast of new regulatory requirements as they are announced.

For more information on how you or your company can achieve compliance with FDA regulations, reach us anytime at contact@sglawfl.com.

Under Section 603 of what is now Public Law 116-94 (“Law”), Congress set forth sweeping changes to federal tobacco laws, which will serve to bring quick change to daily sales practices. To fully understand the breadth of the changes, it helps to look at the previous state of the law and the amendments that were enacted.

Unlike the original Family Smoking Prevention and Tobacco Control Act (“Act”), the changes to the law are self-executing, meaning that further FDA action is not required in order to implement the change. Namely, the original law permitted FDA to enact minimum age restrictions while limiting the Agency to enacting a minimum age no higher than 18.[1] FDA then promulgating regulations establishing 18 as the minimum age for tobacco sales. 21 CFR part 1140. With the most recent law, Congress has effectively taken FDA’s ability to set the minimum age requirements for tobacco sales and has inserted minimum age restrictions into the law. Language was added to establish a minimum age for the sale of tobacco products within the law itself, reading:  

It shall be unlawful for any retailer to sell tobacco to any person younger than 21 years of age.

Public Law 116-94, Section 603(a)(2).

In addition to inserting a federally mandated minimum age restriction into the law, Congress also made key changes that extend existing penalties for violations of the newly established minimum age requirement. Public Law 116-94, Section 603(d). Accordingly, any violation of the new minimum age restriction may result in civil money penalties, tobacco-no-sale orders, and misbranding charges.

As explained above, no further changes must be made by FDA in order to bring the congressionally mandated minimum age into effect. However, FDA will need to change its regulations in order to conform with the federal law. In addition to changing references from 18 to 21, Congress is also requiring FDA to update its regulations to require age verification for all individuals under the age of 30.[2] Currently, 21 CFR 11.40.14 provides that no verification is required for persons over 26.

Although the law does not require further action from FDA in order to implement minimum age requirements or associated penalties, it is unclear when FDA will begin enforcement of these new restrictions, if they have not already. As of December 31, 2019, FDA’s website notes that the Agency “will provide additional details on this issue as they become available.” For now, we will have to wait to see what the New Year brings with respect to FDA tobacco enforcement.

[1] Act at Section 906 (2009).

[2] Public Law 116-94, Section 603(b).

Under federal law, a “modified risk tobacco product” is a product whose label or advertising represents that the product presents lower risk of tobacco-related disease or is less harmful than other commercially-available products. 21 USC 387k. In order to legally market a product as a modified risk tobacco product (MRTP), an order must first be issued by the FDA permitting the marketing as a MRTP. To date, FDA has not issued a single MRTP order.

According to the FDA’s Warning Letter, found here, JUUL representatives allegedly made statements suggesting its products were safe and were safer than cigarettes. If made, these statements would cause JUUL’s products to be marketed as MRTPs, in violation of federal laws and FDA requirements. As with all warning letters issued by the FDA, the Company has 15 business days to respond to the allegations.

The FDA regulates tobacco products under the Family Smoking Prevention and Tobacco Control Act (Act), which was signed into law by President Obama in 2009. The Act grants FDA the authority to regulate various tobacco products, including electronic delivery nicotine systems or “ENDS”, like JUUL products. ENDS and all covered tobacco products must meet FDA requirements, including labeling and marketing requirements and in many cases premarket notification or authorization requirements. If you have questions about marketing tobacco products, please contact us at contact@sglawfl.com.

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.