According to FDA’s announcement, Laclede had a long history of violations with the FDA. In 2012, FDA inspectors found numerous violations of the Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals and other issues surrounding the marketing and sale of unapproved new drugs. As explained by FDA, the company undertook steps to correct the violations, but the Agency deemed the response ineffective. In February 2013, the FDA issued a warning letter to the company for violations of the CGMP and the Federal Food, Drug, and Cosmetic Act (FFDCA) by manufacturing and marketing both over-the-counter (OTC) and prescription drug products without an approved application (unapproved new drugs). According to the FDA Warning Letter, the Agency deemed the products to be drugs due to certain disease claims made in the Company’s marketing materials and since no approved applications were held by the Company, the products were deemed unapproved new drugs. For example, some of the claims at issue included: “Methods and composition for the treatment of vaginal diseases employing peroxide-producing enzymes and peroxidases,” “Helps Prevent The Causes Of Vaginosis, Yeast Infection and Bad Odor,” and “Probiotics: Potential to Prevent HIV and Sexually Transmitted Infections in Women.” Accordingly, the Company’s labeling was one of the major issues that led to FDA’s finding of unapproved new drugs, prompting FDA enforcement action.

On June 25, 2014, the FDA filed for a permanent injunction , as the Agency argued that the Company’s operations remained non-compliant with FDA regulations. That injunction was granted on January 30, 2015. One of the main issues here was Laclede’s failure to properly label their products. The consent decree for permanent injunction specifies that Laclede may not market any products with the words “prebiotic” or “actibiotic” on its labels or packages without first obtaining the FDA’s approval. In addition, Laclede may not market any products referencing “lubrication” without appropriate FDA approval.

In sum, properly labeling products is one of the most critical steps in the product development process. Compliance with the regulations is a must to ensure that your products stay on the shelf and that your company is not the subject of FDA enforcement action. Our firm offers comprehensive label reviews and packaging requirement assistance to help our clients ensure that their products are fully compliant with all applicable rules and regulations. If you would like assistance with your products, please contact us at contact@sglawfl.com.

The consent decree and permanent injunction stemmed from a FDA warning letter issued to Health One in March of 2012, which laid out serious violations of FDA regulations rules. The FDA Warning Letter can be read in its entirety here. The FDA inspected Health One’s manufacturing facility in September 2011 and found serious violations of the FDA’s Current Good Manufacturing Practice (“CGMP”) for dietary supplements. Some of the violations that Health One received included failure to perform tests to verify the identity of dietary ingredients used to manufacture the supplements, failure to establish appropriate manufacturing controls, and failure to maintain, clean and sanitize equipment. Further follow-up inspections revealed that Health One failed to correct many of the manufacturing violations initially cited in the FDA warning letter. Since Health One was in violation of the CGMP, its products were considered “adulterated” by the FDA under the Federal Food, Drug, and Cosmetic Act.

There are CGMPs for various industries, including foods, dietary supplements, drugs and medical devices. To help businesses comply with FDA regulations and manufacturing requirements and explain the rules for industry, the FDA has issued guidance documents for many industries, which can be found here.

Compliance with the FDA regulations is an increasingly difficult task for businesses and failure to comply can spell disaster for companies. In order to avoid recalls and permanent injunctions, it is very important to comply with the CGMP’s and respond appropriately to FDA warning letters. If you have any questions regarding compliance with the various CGMP’s or the Federal Food, Drug, and Cosmetic Act, please do not hesitate to contact us at contact@sglawfl.com.

As we previously reported, on May 16, 2014, representatives from the U.S. Marshals Service had seized more than $11 million worth of unapproved drugs held by Masters Pharmaceuticals of Ohio and marketed by Ascend Laboratories of New Jersey. The U.S. Marshals seized urea cream 39%, hydrocortisone acetate suppositories 25 mg, urea cream 40%, pramoxine-HC otic drops, and urea lotion 40%. The FDA and U.S. Attorney for the Southern District of Ohio requested the seizure because the drugs were not marketed in accordance with FDA regulations, in that they were marketed for conditions that caused them to be deemed drugs but the Company had not secured the necessary FDA approval for the products.

The pramoxine-HC drops were intended to control itching and treat external ear infections caused by bacteria. Ascend Laboratories allegedly marketed the hydrocortisone acetate suppositories for the relief of symptoms caused by ulcerative colitis, inflamed hemorrhoids, and other inflammatory conditions. All three urea-containing products were intended to treat dermatitis, eczema, and other conditions that cause thickening of the skin.

Because none of these products have been proven safe or effective for their intended uses, i.e., obtained FDA approval for the treatment of these diseases and/or conditions, the FDA filed a Complaint alleging that the drugs were misbranded under the Federal Food, Drug, and Cosmetic Act. The complaint came approximately six months after an inspection revealed Ascend Laboratories was allegedly marketing certain products for the treatment of diseases and/or conditions without obtaining FDA approval.

The FDA’s announcement of this seizure explains that these drugs were seized under the Marketed Unapproved Drugs Compliance Policy Guide, which states that any unapproved new drug first marketed after September 19, 2011 is subject to immediate enforcement action even if the marketer never received a prior warning from the FDA. The FDA Compliance Policy Guide for unapproved marketed drugs lists several enforcement priorities. The first two priorities are drugs with potential safety risks and drugs that lack evidence of effectiveness. The FDA is also taking enforcement action against the marketers of so-called health fraud drugs. These products are represented as effective for diagnosing, preventing, curing, or treating diseases, but they have not been scientifically proven safe or effective for their intended purposes.

Drug manufacturers and marketers are subject to close scrutiny under the FDA’s guidelines. The agency has the right to seize drugs and other medical products without any prior warning, putting businesses in this industry at risk for serious losses. If you have any questions about FDA approval or you need help responding to a complaint filed by the FDA, 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.