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.

1. Enhanced produce safety
2. Preventative controls for human food
3. Best practices and guidelines for animal food
4. The foreign supplier verification program

The FDA is looking towards shifting its focus under the FSMA from after-the-fact responses, or a reactionary approach, to a more proactive, science-based prevention system. For example, the FDA is proposing to augment the water quality testing provisions in the produce safety rules, along with further testing of manure and compost used in crop production. The produce safety rule’s minimum applicable sales requirement, which will exempt very small farms from these new FDA regulations, is also open for public comment; right now it makes farms with less than $25,000 in annual produce sales exempt from its safety requirements.

The FSMA was signed into law in 2011 by President Obama and was the most significant food safety regulation in nearly 70 years. The FSMA seeks to promote better public health and to strengthen the nation’s food safety system. We have previously reported about the FSMA and FDA’s program priorities, including defining “gluten free,” regulating energy drinks, and establishing new rules for displaying nutritional facts.

The FSMA is a very important piece of legislation for companies to consider when developing and marketing their products. For the first time ever, under the FSMA, the FDA has the authority to recall food products. In the past, food distributors and manufacturers recalled food on a voluntary basis and through the urging by the FDA. The FSMA also calls for more frequent inspections of food and facilities. Facilities must also develop detailed preventative controls plans, which should spell out the risks to food safety, what is being done to minimize those risks, how the facility will monitor the risks, and what actions will be taken in the event of a problem.

If a company does not comply with the regulations promulgated under the FSMA, the FDA has a number of enforcement options. In addition to mandatory recalls, the FDA, under the FSMA, has expanded administrative detention of products that are potentially in violation of the law, can suspend the registration of facilities that pose a reasonable possibility of adverse health effects, and mandates increased recordkeeping for “high risk” foods. With this new authority, the FDA can suspend food facility registrations and prevent companies from producing and selling their products, like they did with a peanut butter factory in New Mexico.

The FSMA has the opportunity to change the landscape of food industry regulations. To read more about the FSMA, click here. It is important for any company in the food industry to ensure that they are complying will each new regulation. Failing to do so can mean having your company shut down. For that reason, it is important to have an understanding of your requirements under the law with respect to FDA regulations.

If you have any questions about the proposed rules, the FSMA, or compliance with other FDA regulations, please contact us at contact@sglawfl.com

More specifically, the plan lists six goals: (1) reduce foodborne illness rates and cosmetic injury rates each year; (2) establish regulations, policies, guidance, and inspection and compliance strategies based on best science, prevention, and public health risk; (3) increase compliance with newly created preventive control standards across the farm-to-table continuum; (4) improve public health indicators through better nutrition and dietary choices; (5) develop and swiftly deploy the fastest and most effective methods for identifying, containing, and eliminating food and cosmetic hazards.

Each of the six goals corresponds to specific objectives. For example, the Center intends to continue to implement the provisions of the Food Safety and Modernization Act (FSMA). Particularly, in 2014 and 2015, it plans to publish preventive controls—as required by FSMA—for produce, food processing facilities, and food transportation. CFSAN will also publish a final rule for intentional contamination, address an approach to determine high-risk foods and the most significant foodborne contaminants, and draft recordkeeping requirements for high-risk foods.

Additionally, the Center plans to improve the safety and labeling of dietary supplements. This includes developing regulations for “energy drinks” and publishing final guidance to help dietary supplement and beverage manufacturers determine whether a liquid food product, such as an energy drink, may be labeled and marketed as a dietary supplement. By the end of 2013, it will publish draft guidance for new dietary ingredients.

Next, CFSAN has been working to develop new food labeling regulations. Specifically, CFSAN will update the nutrition facts labeling and serving size information on food labels. The Center had also planned to publish a final rule defining gluten-free and on using the term on food labels in 2013, which the Center accomplished on August 5, 2013. In 2014, the Center plans to finalize rules required by the Affordable Care Act of 2010, specifically to require nutrition information on menus and vending machines.

Finally, CFSAN plans to reduce risks related to cosmetics. For example, it will publish guidance on current good manufacturing requirements for cosmetics and finalize guidance regarding the effects of manufacturing process changes, such as nanotechnology, on the safety of cosmetics. In 2014, it intends to develop draft guidance on the use of lead in lipstick.

If you have any questions about this new plan or compliance with FDA regulations, please contact us at: contact@sglawfl.com.

As the FDA explains, the Public Health Security and Bioterrorism Preparedness and Response Act amended the FDCA to require 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 to complete food facility registration with the FDA before beginning these activities. In addition to registration, the Bioterrorism Act requires that certain food businesses maintain and make records available to the FDA that indicate the source of the food or ingredients and the destination for the products. These recordkeeping requirements vary depending on the specific type of business.

Additional food facility registration requirements, found in Section 415 of the FDCA, were enacted by the Food Safety and Modernization Act (FSMA). The FSMA also establishes certain preventive controls to ensure food safety. For example, unless exempted, the owner, operator, or agent in charge of a facility will be required to evaluate the hazards that could affect food manufactured, processed, packed, or held by the facility as well as identify and implement controls to significantly minimize or prevent the occurrence of any hazards. Food facilities will also need to provide assurances that food is not adulterated under section 402 or misbranded under section 403(w) of the FDCA.

Additionally, the article describes the Current Good Manufacturing Practices (cGMP). The cGMP are published in 21 CFR 110. They primarily describe the methods, equipment, facilities, and controls for producing processed food under safe and sanitary conditions. Food manufacturers are also responsible for developing labels that are truthful and not misleading pursuant to the FDCA and other labeling regulations.

Another important regulation is the reporting requirement. Registered facilities must report when there is a reasonable probability that the use of, or exposure to, an article of food will cause serious adverse health consequences or death to humans or animals. FDA allows conventional food companies to voluntarily forward reports of serious adverse events in connection with their products to FDA by submitting Form 3500. The agency requires reporting of serious adverse events involving dietary supplements.

In addition to the laws and regulations enforced by the FDA, food businesses are also subject to other federal, state, and local requirements. If you have any questions about complying with FDA regulations or how a FDA regulatory attorney may help you, please contact us at: contact@sglawfl.com.

After several successive recalls and months of investigation into the adequacy of Sunland’s facilities, the FDA ultimately suspended the Company’s Food Facility Registration, thereby prohibiting Sunland from producing and distributing any food products. A copy of the suspension order may be accessed here. Under the Federal Food, Drug and Cosmetic Act (“FFDCA”), any facility that manufactures, processes, packs or holds food for consumption in the United States must maintain an active registration with the FDA. The suspension of Sunland’s Registration came under the authority of § 102(b) of the recently-adopted Food Safety Modernization Act (“FSMA”). Under this provision, the FDA has authority to suspend the registration of a facility where:

the Secretary determines that food manufactured, processed, packed, received, or held by a facility registered under this section has a reasonable probability of causing serious adverse health consequences or death to humans or animals . . . .

Interestingly, under this provision the FDA may suspend the registration of a facility that: (1) created, caused, or is responsible for the public health issue, or (2) the packer or holder of such food, where this party either knows or has reason to know of such issue. In the present circumstances, because Sunland is the party responsible for processing these peanut butter products, the FDA’s suspension order alleged that the Company was responsible created the probability of adverse health consequences.

This suspension marks the first use of this new enforcement mechanism, which was granted to the Agency under the FSMA. Signed into law on January 4, 2011, the FSMA is frequently cited for expanding the FDA’s powers to proactively handle potential food-related outbreaks. However, with the Agency struggling to develop its regulations under the FSMA, industry has yet to observe much of this new authority in action. Thus, the suspension marks the beginning in what we may see as several “firsts” with respect to the Agency’s new enforcement capabilities.

For more information about maintaining compliance with the FSMA or FDA regulations pertaining to foods generally, feel free to contact us at contact@sglawfl.com.