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 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.

FDA has authority to issue the rule defining gluten free and restricting gluten free labeling under Section 206 of the Food Allergen and Consumer Protection Act (FALCPA) of 2004. Under this provision, Congress directed the FDA to develop regulations pertaining to gluten free and “gluten free” labeling that will help protect consumers who suffer from celiac disease and related illnesses requiring a gluten free diet. The FDA Final Rule, which recently came into effect, defined “gluten free” as having less than 20 ppm (parts per million) of gluten. You can read the rule here. This definition includes foods that do not contain any of the following:

 1. An ingredient that is any type of wheat, rye, barley, or crossbreeds of these grains;

 2. An ingredient derived from these grains and that has not been processed to remove gluten, and

 3. An ingredient derived from these grains and that has been processed to remove gluten, if it results in the food containing 20 or more ppm of gluten.

21 C.F.R. § 101.91 (2014).

The full text of the Final Rule on gluten free labeling may be accessed here. Foods labeled “gluten free” “free of gluten” “without gluten” and “no gluten” have to comply with this requirement as well. However, the use of the “gluten free” labeling is voluntary. Foods that are gluten free in-fact are not required to bear “gluten free” labeling.

Any food with a manufacture date after August 5, 2014 will have to comply with this labeling requirement. However, the coast is not completely clear for consumers. Some food items that hit the marketplace prior to August 5 may still not be in compliance with this final rule. If foods are misbranded, meaning that they bear “gluten free” labeling and they are not in fact gluten free, then the manufactures and/or distributors of these foods are subject to regulatory action by the FDA pursuant to the Food, Drug, and Cosmetic Act (FDCA). These actions may include warning letters, detention upon importation, and other types of enforcement measures. More information about gluten-free labeling of foods is provided on the FDA’s website, accessible here.

If you are concerned that your product labeling may not be in compliance with the new requirements, it is important to take steps to ensure your compliance in order to avoid regulatory action. Federal regulatory enforcement actions can be time consuming and costly for a business, as they can result in time-consuming delays and even product recalls. If you have any questions about the final rule on gluten free labeling or compliance with FDA regulations, please contact us at: contact@sglawfl.com.

The FDA approved Botox Cosmetic for treating crow’s feet after the drug’s safety and effectiveness for that intended use were established by two clinical studies. Under the Federal Food, Drug, and Cosmetic Act (FDCA), the FDA approves drugs for certain indications, or conditions, commonly known as intended uses. To be approved by the agency for a particular use, the drug sponsor must submit an application to the FDA demonstrating that the drug is safe and effective for the particular intended use.

Doctors commonly prescribe legally marketed drug products for indications not in the approved labeling, however. Botox Cosmetic, for example, was frequently used by doctors to treat crow’s feet prior to being approved for this intended use. This “off-label” use does not require approval by the FDA as long as the intent is the practice of medicine and the use is based on the doctor’s sound medical judgment. In comparison, the FDA typically prohibits the direct marketing of FDA-approved drugs for indications other than those included on the drug’s labeling. Accordingly, while such a limitation is not placed on physicians, the FDA prohibits drug sponsors and marketers of drug products from promoting products for intended uses other than those that are approved by the agency.

In sum, Botox Cosmetic is currently the only FDA-approved treatment for lateral canthal lines. In addition to treating canthal lines, Botox is also approved for several intended uses, including temporary improvement of glabellar lines (frown lines), treatment of chronic migraines, severe underarm sweating, blepharospasm (eyelid spasm) and strabismus (misalignment of the eyes).

More information about the FDA drug approval process can be found on the agency’s website. If you have any questions about the drug approval process or compliance with FDA regulations, please contact us at: contact@sglawfl.com.

Section 415 was added as an amendment to the FDCA by Section 305 of the Public Health, Security, and Bioterrorism Preparedness and Response Act of 2002. It primarily establishes the requirement that the owner, operator, or agent of a domestic or foreign food facility, as defined by 21 CFR 1.227, where food is manufactured, packed, or held for human or animal consumption, complete food facility registration with the FDA. Failure to maintain such food facility registration, regardless of whether the food actually enters interstate commerce, is prohibited under Section 301(dd) of the FDCA. Applicable exceptions to this requirement are listed in 21 CFR 1.226.

The Food Safety and Modernization Act (FSMA), enacted on January 4, 2011, added additional requirements to Section 415 and the requirements pertaining to food facility registration. Registration applications, for example, must include the email address of the contact person for a domestic facility, the email address of a US agent for a foreign facility, and a guarantee that the FDA will be permitted to inspect the facility as authorized by the FDCA.

Additionally, Section 415 (a)(3), as amended by the FSMA, requires that a food facility registration be renewed by the FDA biennially. More specifically, any food facility that previously registered with the FDA must submit a renewal from October 1 to December 31 of each even numbered year. An abbreviated process is available when no changes have been made to the previously submitted application. The FDA will consider the facility to have failed to comply with the mandatory food facility registration if its registration is not renewed.

Finally, Section 415(b) authorizes the FDA to suspend a facility’s food facility registration under certain circumstances. Particularly, if the FDA finds that food manufactured, processed, packed, received, or held at a registered facility has a reasonable probability of causing serious adverse health consequences to humans or animals, the FDA will suspend the registration of the facility. If a facility with a suspended registration, moreover, introduces food from the facility into interstate or intrastate commerce in the United States, it will be subject to an appropriate enforcement action by the FDA.

In sum, the comment period for the draft ends on May 6, 2013. You can read more detailed information about food facility registration here. If you have any questions about compliance with the food facility registration requirements or how a FDA regulatory attorney may help you, please contact us at: contact@sglawfl.com.