Scotty’s had previously received a Warning Letter in 2009 for failing to have adequate processes and controls in place to minimize the risk of contamination and for failing to have a written HACCP plan for the tuna salad sandwiches prepared at the business. Then, in 2010 and 2014, FDA inspectors documented what the Agency alleged to be the company’s failure to manufacture, package and store food under conditions and controls necessary to minimize the potential for growth of microorganisms and contamination. According to the FDA, the Company failed to heed the Agency’s prior warning and was still not in compliance with HACCP regulations.

There have been no reported complaints from the public or reports of illnesses from the sandwiches from Scotty’s Incorporated, which does business as Bruce Enterprises and Bruce’s Fresh Products.

FDA HACCP Regulations

HACCP is a food safety system which encompasses all facets of food production, from manufacturing, to distribution, to consumption of the finished product. HACCP plans analyze food safety issues resulting from biological, chemical, and physical hazards. The HACCP management system relies on the following seven principles:

1) Conducting a hazard analysis;

2) Determining the critical control points (CCPs);

3) Establishing critical limits;

4) Establishing monitoring procedures;

5) Establishing corrective actions;

6) Establishing verification procedures, and

7) Establishing record-keeping and documentation procedures.

Appendix C describes the questions that a typical HACCP team will need to consider when creating a plan. A typical plan includes hazard analysis, decision-making trees, and verification processes as well as procedures for record keeping.

Currently, there are generic HACCPs for the dairy, juice, seafood, and retail and foodservice industries. However, the FDA encourages each food producer to assemble an HACCP team to devise a strategy to make an HACCP plan. Each HACCP plan will vary, depending on the industry, product, and specific process utilized by each individual company.

In addition, it is important to note that there are various exemptions to the HACCP requirements. For example, under the juice HACCP regulations, a person who makes and sells apple cider or other fresh juices directly to consumers may not be required to have a HACCP plan or otherwise comply with HACCP requirements. However, a person who sells their juices to a store which will then sell to customers is required to have an HACCP plan.

Determining whether an exemption to HACCP requirements exists is a complex task. Due to the number of different requirements, such as the retail juice exception, voluntary HACCP rules for food service industries, and requirements for pasteurized milk, it is important to ensure that you are complying with all applicable regulations prior to beginning operations. For questions regarding HACCP plans and compliance with FDA regulations, please contact us at contact@sglawfl.com.

Previously, on March 23, 2011, the FDA issued a warning letter to Jonlly, noting that its products were adulterated under the FDCA due to the company’s failure to develop the required HACCP plan for its orange juice concentrate. According to Section 402 (a)(4), a food is adulterated if it has been prepared, packaged, or held under insanitary conditions whereby it may have been rendered injurious to health. Under 21 C.F.R. § 120.7(a), the FDA requires the processor of juice products to conduct a written analysis of the hazards that are likely to occur during each type of juice processing. In addition, processors must develop a system to control the hazards, including a written plan that outlines the necessary controls. If juice processors or manufacturers fail to comply with these HACCP requirements, their products will be deemed adulterated. You can read more about the HACCP requirements for juice here.

Also, at the Jonlly facility the FDA found serious violations of the Current Good Manufacturing Practices (“cGMPs”). The Current Good Manufacturing Practices are published in Title 21 of the Code of Federal Regulations, Part 110. They describe the methods, equipment, facilities, and controls for producing processed food. Allegedly in violation of these regulations, Jonlly failed to maintain minimum sanitary and processing requirements, including preventing the contamination of its juice products and maintaining a proper temperature.

Finally, many of Jonlly’s products were deemed misbranded under the FDCA, as the labels displayed a nutrient claim but did not meet the FDA requirements to make the particular claim. Characterizing the level of a nutrient in food labeling of a product without complying with the specific agency requirements pertaining to nutrient content claims for that nutrient causes a product to be deemed misbranded within the meaning of Section 403(r)(1)(A). For example, many of Jonlly’s product labels declared the claim “light” but did not provide a reference food as specified under 21 CFR 101.13(j) and 101.56(b). Also, certain Jonlly labels declared “100 % Vitamin C” which is an incomplete nutrient content claim. In particular, the labels failed to describe the percentage of Vitamin C in relation to the Reference Daily Intake (RDI) for the vitamin in a serving of the products.

In addition to the present action, the FDA’s announcement notes that Jonlly Fruits has a long history of noncompliance with the laws and regulations enforced by the agency. In addition to warning letters, in 2012, a recall was issued due to undeclared allergens in several of the company’s products. Overall, Jonlly Fruits has a history of violations which, according to the FDA, have gone largely uncorrected. For more information about the importance of correcting violations cited in warning letters and how such responsiveness may be beneficial in the long-run, see our previous reports here.

For more information about compliance with food processing and labeling requirements, please contact us at contact@sglawfl.com.