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.

BioAnue received a warning letter from the FDA on February 9, 2012, alerting the Company to what the FDA argued were numerous violations of FDA regulations. The Warning Letter can be found here. According to the FDA’s recent action, BioAnue not only failed to respond directly to the warning letter, the Company also failed to correct the violations highlighted in the Warning Letter. After having received the Warning Letter, the FDA conducted a follow-up inspection in August 2012, which, according to the FDA, revealed that BioAnue was still in violation of the FDA’s current good manufacturing practice requirements for dietary supplements and other regulatory requirements. More information about good manufacturing practices and the applicability of these practices to the dietary supplement industry can be accessed here.

In addition to FDA’s Good Manufacturing Practices, the FDA initially targeted BioAnue with a Warning Letter because they sold products that were marketed for use in the cure, mitigation, treatment, or prevention of disease. Marketing a dietary supplement for these uses causes dietary supplement products to be deem “drugs”, as defined in section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act found at 21 U.S.C. § 321(g)(1)(B). However, dietary supplements can be sold without being classified as “drugs” as long as they are not marketed with disease claims and instead are marketed with at most, structure-function claims or other permitted health claims. More information about structure-function claims may be accessed on the FDA’s website. However, it must be noted that sometimes the difference between a structure-function claim and a disease claim is not a bright line and even slight changes in wording can cause an otherwise permissible claim to be deemed a disease claim by the FDA.

We always stress the importance of responding to FDA warning letters with timely and adequate remedial measures, including resolving the issues cited in the letters, as well as promptly communicating with the FDA. You can read more about FDA warning letters and the importance of responding appropriately thereto here. FDA warning letters may be a serious threat to business, as seen in this case, where lack of response ultimately may be seen as prompting increased enforcement. Accordingly, it is possible that responding to a FDA warning letter can be the difference between maintaining business operations and being prevented from selling or marketing FDA-regulated products, as with the issuance of a permanent injunction. For more information about cases involving warning letters, please read some of our previous blog posts here.

If you have any questions about FDA labeling rules, warning letters, or compliance with FDA regulations pertaining to dietary supplements, please contact us at contact@sglawfl.com.

After the inspection, on June 6, 2013, the FDA issued a warning letter to the Serra Cheese Company, which can be found here. The FDA Warning Letter laid out the findings of the FDA visit to the plant along with the numerous violations. It also asked the company and its owners to respond within 15 working days to describe in detail the steps that the company is taking to correct its violations. S. Serra Cheese never responded to the FDA Warning Letter. Rather, the FDA’s requests went unanswered. Ignoring FDA warning letters often prompts the FDA to take action, which is often extremely costly and can cause delays, even halting business altogether. As Melinda K. Plaisier, the FDA’s Associate Commissioner for Regulatory Affairs explains, “[w]hen a company ignores warnings or refuses to address food safety issues that put consumers at risk, the FDA must take action.”

You can read more about FDA warning letters and the importance of responding appropriately thereto, here. In order to resolve issues stemming from FDA warning letters, a company must provide the FDA with a detailed plan of action, describing specific things the company is doing to correct the violations. A company should include relevant documentation or other useful information that would assist the FDA in evaluating the thoroughness of the corrections. After submitting a plan to the FDA explaining these remedial steps, a company will sometimes receive another letter from the FDA with a determination of whether the FDA thinks the proposed steps will adequately resolve the problems at hand.

It is extremely important to respond to FDA warning letters both promptly and thoroughly. A FDA warning letter could result in penalties for your business, and in the case of S. Serra Cheese Company, the potential for personal liability. If you have any questions about FDA warning letters or compliance with FDA regulations, please contact us at contact@sglawfl.com.

The FDA is targeting James G. Cole for unlawfully marketing its dietary supplements as unapproved drugs in violation of the Federal Food, Drug, and Cosmetic Act (“FDCA”). More specifically, the FDA is alleging that the company makes “drug claims” on its website and product labeling by promoting its dietary supplements as treatments for serious medical conditions such as cancer, heart disease, and arthritis. Under the FDCA, any product sold as a dietary supplement and promoted as a treatment, diagnosis, cure, or prevention of a disease or condition loses its status as a dietary supplement and is considered a new drug. Unlike drugs, the labeling of dietary supplements are only allowed to contain health claims, structure/function claims, and nutrient content claims, as permitted by FDA regulations.

Additionally, the FDA alleges that at the James G. Cole facility, the agency found serious violations of the cGMP requirements for dietary supplements, which are published in Title 21 of the Code of Federal Regulations, Part 111. These requirements mandate that any person who manufactures, packages, labels, or holds a dietary supplement establish and follow current good manufacturing practice to ensure the quality of the dietary supplement and to ensure that the dietary supplement is packaged and labeled in compliance with the master manufacturing record. FDA argues that in violation of these regulations, James G. Cole did not establish an “identity specification” for each component in its dietary supplements and did not conduct at least one appropriate test to verify the identity of a dietary ingredient.

In sum, failure to comply with the laws and regulations pertaining to dietary supplement labeling and manufacturing operations can have serious consequences, including the halting of distribution altogether. Accordingly, it is important to establish compliance with the laws and regulations enforced by the FDA in order to avoid costly delays and stoppages. If you have any questions about compliance with dietary supplement regulations or other laws enforced by the FDA, 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.

There have been no illnesses or serious side effects associated Globe All products to date. Rather, the seizure was prompted due to the presence of undisclosed active drug ingredients, improper marketing claims and a continued failure to comply with current Good Manufacturing Practices (cGMPs).

In particular, the FDA’s Press Release also noted that products that have been marketed in the past by Globe All claim to lower cholesterol and blood pressure, among other claims. Under the Federal Food, Drug, and Cosmetic Act (FFDCA), products that are offered for the treatment of diseases or conditions in man are considered to be drugs and regulated accordingly.

In addition, during prior inspections of Globe All in October 2012 and February 2013, the FDA found the Company was distributing dietary supplements that were not being manufactured in accordance with the FDA’s current good manufacturing requirements that are in place for dietary supplements. These rules became effective in June 2008 and apply to all supplement manufacturers, requiring these parties to ensure that their products are properly labeled and free from contamination, among other things. These regulations also mandate that dietary supplement manufacturers keep certain records in relation to the manufacturing process and conditions thereof. More information about cGMPs for dietary supplements may be accessed here.

In sum, there were a number of issues with the manufacturing and labeling of the products prior to the seizure in the present case. Because various enforcement measures are often taken prior to conducting a seizure, it is important to understand how compliance with the laws and regulations enforced by the FDA can help a company avoid being further targeted by the government.

If you have questions about FDA regulations regarding the manufacturing, distribution and marketing of dietary supplements, 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.

Like most regulations pertaining to medical devices, the FDA intends to implement the new UDI system using a risk-based approach, meaning that the focus is on devices with the highest risk, i.e., Class III medical devices, and the Agency will exempt low risk, or Class I, devices from some or all of the new regulatory requirements. Similarly, the FDA currently does not require notification prior to the initial distribution of many low risk devices and exempts these devices from various other regulatory requirements. For more information about the UDI system or medical device regulation generally, please contact us at contact@sglawfl.com.

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The FDA’s regulation of medical devices follows a three-tier approach. Class I devices, or the least-risky devices, typically do not require notification to the FDA prior to marketing. At the other end of spectrum, Class III devices are largely required to undergo the premarket approval (“PMA”) process. While Class II devices typically do not require a PMA, most of these devices must be cleared for marketing by the FDA through the premarket notification (“510(k)”) process. Through this process, device sponsors must notify the FDA of their intent to market a device, while demonstrating that the candidate device is substantially equivalent to a device that has been marketed prior to May 28, 1976 (the date of the Medical Device Amendments) or to devices that have otherwise been reclassified under the Federal Food, Drug and Cosmetic Act (“FFDCA”) and do not require a PMA. More information about the FDA’s classification of medical devices may be found here.

Once a device has received FDA clearance through the 510(k) process, it is then subject to continuing monitoring by the FDA whether through reporting requirements or through adherence to Quality System Regulations (“QSRs”). Additionally, if a device that has been cleared undergoes a modification that bears upon its safety and effectiveness, the device sponsor may need to submit another 510(k) in order to continue legally marketing the device. More information about modifications to cleared devices may be accessed here.

The regulation of bottled water may be broken into two main areas: CGMPs and labeling. Current Good Manufacturing Practices (“CGMPs”) are the particular guidelines that producers of most FDA-regulated products must adhere to in the manufacture of their products. Particularly applicable to bottled water products, these guidelines require that bottled water be processed under sanitary conditions, and among other things, that producers test the source water and final product to ensure the water is safe and free from contaminants.

In addition to CGMP requirements, bottled water producers and distributors must comply with the FDA’s various labeling regulations. Depending on the particular water being sold, bottled water labels must contain certain declarations to ensure that the public is made aware of what they are drinking. While one might think that water is water, the FDA recognizes several distinct types of waters, including mineral water, spring water, purified water and flavored water. Ultimately, while bottled water appears to be a straightforward product, the FDA’s regulatory oversight in this area is expansive.