Nov 13

USDA Organic Labeling

The United States Department of Agriculture (USDA) oversees the National Organic Program and organic labeling in the United States. The National Organic Program is a regulatory program housed within USDA Agricultural Marketing Service, which sets standards for organically produced agricultural products. These standards do not address food safety or nutrition, as these issues are within the regulatory oversight of FDA or other USDA programs. The statutes under which the National Organic Program operates are found here.

When a company wants to use organic labeling or label a product in a way that promotes the use of to organic ingredients, they may use the phrase, “made with organic ____” in labeling if the product meets the requirements set out in the statutes. First, the USDA must certify operations that grow, handle, or process organic products as organic. In other words, the producer of the organic material must be certified as “organic” by the USDA. Subpart E of the National Organic Program governs organic certification.

Foods that are labeled with the “Made with organic” language must comply with strict requirements. First, they contain at least 70% organic ingredients, 7 CFR § 205.301(c). As opposed to organic labeled foods, this means that a “Made with organic ____” product may contain a maximum of 30% nonorganic ingredients, as set forth in the National List of Allowed and Prohibited Products, codified at 7 CFR § 205.605.  Further, these types of products must not contain any ingredient made using any of the prohibited methods as listed in 7 CFR § 205.105.

Products are only allowed to list three (3) ingredients, food groups, or combination of ingredients and food groups after the “Made with organic ____” statement. A generic “Made with organic ingredients” statement is prohibited. There are also many other restrictions on the types of labeling allowed with organic ingredients. For example, when a product uses organic and inorganic versions of the same ingredient, the ingredients must be listed separately on the ingredients list. Further, specific ingredients cannot have their own “percent organic” label. A label that includes “100% organic sugar” is in violation of the National Organic Program. For more examples of prohibited labels and how to fix labeling problems, the USDA has produced a guidance document, or explanatory document setting forth the Agency’s current policy on the topic.

If a company wants to include a food group-specific label claim on their “Made with organic” statement, the only food groups that can be listed are beans, fish, fruits, grains, herbs, meats, nuts, oils, poultry, seeds, spices, sweeteners, vegetables, or processed milk. All other food groups are prohibited to be listed as “Made with organic” as described in 7 CFR § 205.304. In addition, these label claims must be truthful. As with other ingredients, if it is going to be included as a “Made with organic” ingredient, all raw and processed forms of that ingredient must be certified organic.

The world of organic labeling is ever-changing and has very specific requirements. Labeling your product is a very complex task and doing so incorrectly can result in penalties ranging from suspension to rejection of the company’s organic status. Knowingly selling a product labeled as organic or with some form of organic labeling that does not comply with the organic labeling regulations can result in fines of up to $11,000 per violation. For questions regarding organic labeling and for inquiries about label reviews of your product labels, please contact us at contact@giannamore-law.com.

FDA Attorney 150x150 USDA Organic Labeling

Oct 31

FDA Food Allergen Labeling

When consumers with food allergies are purchasing food products, they normally examine the food labels to make sure a product does not contain any ingredients that would cause them to have an adverse reaction. Milk, eggs, fish, shellfish, nuts, wheat, peanuts, and soybeans are all common ingredients considered “major food allergens” that can potentially cause life-threatening consequences for consumers with allergies. The U.S. Food and Drug Administration notes that each year in the United States, food allergies cause 30,000 visits to the emergency room, 2,000 hospitalizations, and 150 deaths. Because of these health concerns, food allergen labeling has emerged as an important area in federal regulation.

Every year, countless food product recalls are caused by “undeclared allergens”, which are major allergens not listed on product labels. A list of all current recalls, including those that were recalled due to food allergen labeling issues, can be found here. For example, The U.S. Food and Drug Administration (FDA) published notification of a recent recall of vegan gingersnap cookies, which were removed them from shelves when it was found that they contained tree nuts, milk, soy, and egg, none of which were listed on the product labels and therefore the products were not compliant with food allergen labeling regulations.

Federal law requires that food producers and distributors include allergy information on their labels. The Food Allergen Labeling And Consumer Protection Act of 2004 (FALCPA) governs the disclosure of certain allergens on food labels. The FALCPA only requires disclosure of 8 major food groups on labels, although there are over 160 foods that produce allergies in humans. However, the FDA has found that over 90% of food allergies are caused by the following 8 major food groups: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans. In addition, on August 5, 2013, the FDA issued a final rule regarding the labeling of “gluten free” foods, which as also authorized by FALCPA as part of the laws on food allergen labeling. As of August 2014, the FDA has started to enforce this rule, just as they do with the other 8 major food allergens.

The Food Allergen Labeling and Consumer Protection Act requires that food products be labeled in very specific ways. There are two ways to label foods containing allergens. First, the common name of the allergen can be placed in the ingredient statement. Second, the food producer can include a “contains” statement, which includes the food source from which the major food allergen is derived. For example, the food label should look like this.

The FALCPA does not apply to “cross-contact” situations that may arise during manufacturing, such as shared equipment or processing lines. Food producers are encouraged to use food allergen advisory statements, such as “may contain [allergen]” or “produced in a facility that also produces [allergen].”

When a company violates the food allergen labeling requirements of the FALCPA, they may be subject to civil sanctions, criminal penalties, or both under the Federal Food, Drug, and Cosmetic Act. FDA may also request seizure of food products where the label of the product does not conform to FALCPA’s requirements. To avoid these heightened enforcement measures, many companies will opt to recall their products, as shown above.

Labeling your product requires intricate knowledge of many different statutes and regulations, such as FALCPA, the Federal Food, Drug, and Cosmetic Act, and the Food Safety Modernization Act (FSMA). We have previously blogged about the FSMA, food labeling, and the penalties for not complying with FDA regulations. For questions regarding food labeling and for inquiries about label reviews of your  product labels, please contact us at contact@giannamore-law.com.

Oct 27

FDA Imports: Foods and Cosmetics

Do you ever wonder how your favorite exotic cheese, foreign cookies, or champagne make it to the United States? As it turns out, importing food and cosmetics into the United States is not as simple as putting it in boxes and shipping it to the supermarket or local drug store. The U.S. Food and Drug Administration (FDA) is guided by a comprehensive statutory scheme that governs food and cosmetics produced in foreign countries and imported into the United States. Understanding the issues surrounding FDA imports, including how the importation of foods and cosmetics are affected by federal regulations, is important for timely, cost effective importation.

FDA Imports: Food Imports

All food that is imported into the United States has to meet the same requirements as food that is domestically produced, or manufactured within the United States. This means that imported food has to comply with The Federal Food, Drug, and Cosmetic Act (FD&C Act), The Fair Packaging and Labeling Act, and The Nutrition Labeling and Education Act (NLEA), which amended the FD&C Act. These requirements include ensuring all ingredients are permitted for use in foods and that the product labels comply with federal regulations. All imported foods are inspected when offered for import or entry into the United States.

Recently, food security has become a larger national priority, which has resulted in increase regulation in the area of FDA imports. In particular, Congress enacted The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act), which requires food manufacturers and importers to: (1) register with FDA every two years and (2) submit prior notice of the imported food, which means that the importer must alert the FDA to what they are planning on importing before the shipment is offered for import. The prior notice requirement is waived a few distinct circumstances:

1. The food is brought into the United States by an individual for personal consumption;

2. Food that is imported and then exported without leaving the port of arrival;

3. Personal gifts sent from an individual in a foreign country to an individual in the United States;

4. Diplomatic gifts to an embassy in the United States, and

5. Food products that are the subject of exclusive jurisdiction of the U.S Department of Agriculture, such as meat, poultry, and eggs.

Additionally, Under the Food Safety and Modernization Act (FSMA) of 2010, if the imported food was refused entry in another country, the prior notice must also identify the other countries where the food was refused entry.

FDA Imports: Cosmetic Imports

Cosmetics imported into the United States must also comply with the same laws and regulations as those produced in the United States. Cosmetic products cannot have any prohibited ingredients and must be safe for their intended uses. Similar to foods, ingredients and labeling must be compliant with FDA regulations. Companies importing cosmetics are not required to register with the FDA but are encouraged to do so through the Voluntary Cosmetic Registration Program.

In addition to the above concerns, importers of cosmetics must be aware of other laws that could possibly govern their products. Many times, other countries have different definitions of drugs and cosmetics than the United States uses. For example, in the United States, sunscreen is regulated as a drug, while in other countries; it is regulated as a cosmetic product. Also, a product can be both a cosmetic and a drug. Importers should be aware of the different classifications and requirements for their products.

Navigating the maze of requirements for importing food products and cosmetics can be a complex task and there are several points to consider when dealing with FDA imports. If you are importing food products or cosmetics into the United States, compliance with the FDA regulations applicable to FDA imports is important. If you have any questions about compliance with the FDA import regulations and programs, please contact us at contact@giannamore-law.com.FDA Attorney 150x150 FDA Imports: Foods and Cosmetics

 

Oct 22

FDA Approval Required for Company Enjoined from Marketing Products

On October 10, 2014, a federal judge from the U.S. District Court for the Southern District of Ohio sided with the U.S. Food & Drug Administration (“FDA”) and entered a consent decree for permanent injunction against Ascend Laboratories, LLC. As we previously reported, Ascend had been targeted in connection with the marketing and sale of certain products, deemed drugs by the FDA, without first obtaining formal FDA approval. As explained in FDA’s announcement of the injunction, the Company is now enjoined from marketing these products until they first secure FDA approval and post bond to recover the seized products.

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@giannamore-law.com.FDA Attorney 150x150 FDA Approval Required for Company Enjoined from Marketing Products

Oct 14

Court Finds FDA Exceeded Authority in Device Reclassification

On September 26, 2014, The United States Court of Appeals for the District of Columbia Circuit ruled that the FDA had “short circuited” its procedural requirements, pertaining to device reclassification and formal rulemaking, when it reevaluated a medical device being sold on the market in an effort to require the device to obtain further approval. The medical device that was the subject of the controversy was an absorbable surgical mesh, designed for use in knee replacement surgeries, called the Collagen Scaffold. In 2008, the device manufacturer obtained clearance from the FDA, through the 510(k) process, to market the Collagen Scaffold. After the device was cleared and being marketed in the United States, the FDA later attempted to rescind the clearance, amidst pressures arguing that the Agency improperly cleared the device. This rescission was given by notifying the Company that the clearance was “in error” and that the Company must seek approval under the Premarket Approval (“PMA”) process. The FDA then issued an order, which rescinded its original decision clearing the Collagen Scaffold through substantial equivalence and immediately took the product off the market.Ultimately, this resulted in what the Court considered to be an improper device reclassification.

The Court found that the FDA would have to utilize formal device reclassification procedures if the Agency wanted to make changes to the device’s status. Device reclassification, which is accomplished through the formal rulemaking process, removes a device from the market, requiring the device to go through the approval process before it can be marketed again. This process includes a notice and public comment period before the device reclassification is finalized and the device may be removed from the market. Accordingly, by finding that the FDA must actually reclassify a cleared device in order to have the authority to effectively change its previous determination, the Court found that the FDA had exceeded its authority in the present case. In addition, the Court struck down the FDA’s assertion that it had “inherent reconsideration authority” when reclassifying a device. The court’s holding reinforces the importance of the device reclassification procedures outlined in the Federal Food, Drug, and Cosmetic Act (“FFDCA”), which include notice and public comment through formal rulemaking.

The Federal Food, Drug, and Cosmetic Act mandates that the FDA classify medical devices into one (1) of three (3) categories, Class I, Class II, and Class III. Class I devices generally pose little to no risk and are subject to the least amount of regulatory controls. Class II devices are higher risk devices that require increased regulatory controls and typically must receive clearance prior to marketing. Class III devices are the highest risk devices and are subject to the strictest regulatory control; Class III devices must be approved by the FDA prior to being released to the market.

Generally, prior to marketing a Class II device, the device sponsor must utilize the Premarket Notification process, as prescribed in Section 510(k) of the FFDCA. For more information on Section 510(k) please visit our website. Failure to comply with Section 510(k) can result in serious consequences. For Class III devices, Premarket Approval, as distinguished from clearance, is required, unless it falls under the exemptions found in applicable FDA regulations.

With respect to device reclassification, the FDA must take very specific steps, as outlined in section 515 of the FFDCA, in order to properly reclassify a device. In particular, the FDA must do five (5) things before a device can be reclassified:

  1. Collect existing scientific information from scientific experts in the medical community and assess the risks and benefits of the medical device type subject to the device reclassification;
  2. Convene a meeting of the medical device advisory committee to request input on the device reclassification;
  3. Issue a proposed order reclassifying the device type into Class I, II or III;
  4. Review and consider comments submitted by the public, and
  5. Issue a final order reclassifying the device type into Class I, II or III.

If you are marketing a medical device, compliance with the FDA regulations is important. If you have any questions about compliance with FDA regulations, please contact us at contact@giannamore-law.com

FDA Attorney 150x150  Court Finds FDA Exceeded Authority in Device Reclassification

Oct 05

FTC-FDA Warning Letter Issued to Company Marketing Ebola Cure

On September 23, 2014, the U.S. Food & Drug Administration (“FDA”), in conjunction with the Federal Trade Commission (“FTC”), issued a Warning Letter to Natural Solutions Foundation in Newton, New Jersey. FDA representatives allege the FDA warning letter was prompted by the certain marketing. In particular, the Company violated the Federal Food, Drug, and Cosmetic Act by promoting the use of several products to cure, treat, mitigate, or prevent disease. According to the letter, Dr. Rima Laibow promoted Nano Silver as a “natural therapy” or “cure” for the Ebola virus. Additionally, Laibow’s website contained claims referring to the product as a “universal infection solution” and “powerful natural protection” against disease.

Because several products promoted on the website are not generally recognized as safe and effective for eradicating the Ebola virus, the FDA considers them new drugs under §505(a) of the Federal Food, Drug, and Cosmetic Act. Under this act, a drug may not be introduced or delivered for introduction into interstate commerce unless the FDA has determined it is safe for consumers.

The FDA also alleges the products promoted by Dr. Laibow are misbranded under §502(f)(1) of the Federal Food, Drug, and Cosmetic Act. These products are considered misbranded because they are offered for conditions that cannot be self-diagnosed or treated by someone who is not a medical professional. As a result, there is no way to provide adequate instructions for using the products safely and for their intended use.  The Warning Letter gives Dr. Laibow 15 working days to submit a list of steps taken to correct these violations.

The FTC alleges Dr. Laibow violated the FTC Act by making product claims without reliable scientific evidence. Under the FTC Act, it is unlawful to claim that a product can treat, prevent, or cure disease in humans unless there is competent and reliable scientific evidence to support those claims. The FTC advised Dr. Laibow to carefully review all claims and ensure there is scientific evidence to support them. Dr. Laibow has 15 working days to respond to the FTC’s concerns.

Although a FDA Warning Letter constitutes an informal action on the part of the FDA, it is a sign that a formal enforcement action may happen if a company does not address the alleged deficiencies. This is why it is so important to take these warnings seriously. The FDA often targets companies making claims related to highly publicized outbreaks. Since the Ebola outbreak made the news, the Agency has also sent FDA warning letters to Young Living Essential Oils and doTERRA Essential Oil because their independent consultants allegedly promoted essential oils as an effective treatment for the Ebola virus.

If you have any questions about complying with the Federal Food, Drug, and Cosmetic Act, or you have received a FDA warning letter, contact us at contact@giannamore-law.com to discuss your concerns with counsel.

FDA Attorney  150x150 FTC FDA Warning Letter Issued to Company Marketing Ebola Cure

 

Sep 29

FDA Releases Proposed Rules under FSMA

On September 19, 2014, the U.S. Food and Drug Administration (FDA) released revisions to four proposed rules, opening them up for public comment. When these four rules are finalized in 2015, they will implement portions of the FDA Food Safety Modernization Act (FSMA) of 2011. The four new rules open for public comment set guidelines for the following food safety issues:

  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@giannamore-law.com

Sep 08

FDA Inches Closer to New Nutrition Facts Panel Rules

On August 1, 2014, the U.S. Food and Drug Administration (FDA) closed its comment period for a proposed rule that would make significant changes to food labeling requirements, particularly nutrition facts panels. Per the Administrative Procedure Act, the FDA is currently reviewing the 264,723 comments that it received regarding the proposed rule and changes to nutrition facts panels that appear on all FDA-regulated food products. The proposed rule can be found here. As soon as the rule is finalized, it will be implemented in sixty (60) days’ time. For existing products, manufacturers will have two (2) years to comply with the new rules, meaning that while new labels for existing products will need to be printed, industry will have two (2) years to comply with the new rules, once implemented.

The major changes from the old rule to the new rule are outlined here. The new rule changes the iconic “nutrition facts” panel design to emphasize parts of the label that reflect current public health concerns like obesity, diabetes, and cardiovascular disease. The new “nutrition facts” panel on labels would look like this, with the text displaying the calorie count enlarged, the percentage of daily value moved to the left side, and changing the footnote to better explain the percent daily value of certain essential nutrients.

The new rule also makes changes that reflect a better understanding of food and nutrition science. When the nutrition facts panels on labels were first introduced more then 20 years ago, the amount and quality of information regarding diet and foods were not as expansive as they are today. For example, the FDA’s new food labeling rule and updated nutrition facts panel would eliminate the “calories from fat” from the label since research has resoundingly shown that the type of fat is more important than the amount alone.

In addition, according to the FDA, the FDA’s new food labeling rule would better reflect the eating habits of the American public. The Agency notes that the rule, if implemented, will require packaged foods that are typically consumed in one sitting to have their serving size labeled as one serving, instead of more than one serving. According to the FDA, the change in serving size will help more accurately reflect consumer behavior. For an example of this new serving size rule, the FDA has published an info-graphic that illustrates this shift in consumers’ eating habits, addressing the need for changes in serving sizes.

The new rules apply to packaged foods. However, like other FDA labeling rules, the new nutrition labeling regulations will do not extend to foods served at restaurants. Food manufacturers will have two (2) years after the rule’s effective date to come into compliance with all of the new regulations. According to the FDA, the rule has a one time initial cost to the industry of $2.3 billion, but the rule is expected to bring $21 to $31 billion in cumulative benefits to consumers over the next 20 years.

As with all FDA regulations, it is important to maintain compliance with these rules to avoid adverse Agency action or other delays in the manufacturing and distribution chain. Failure to comply with FDA regulations can result in warning letters, delays in importation, injunctions, or other adverse action, which ultimately can prevent your company from doing business in the United States. Accordingly, remaining knowledgeable about new regulations and implementing measures to ensure compliance are important when dealing with FDA-regulated products.

If you have any questions about the changes to the nutrition facts panels, FDA labeling regulations or compliance with other FDA regulations, please contact us at contact@giannamore-law.com

FDA Attorney  150x150 FDA Inches Closer to New Nutrition Facts Panel Rules

Sep 02

Dietary Supplement Company Prohibited from Operations After Ignoring FDA Warning Letter

On August 8, 2014, the U.S. Food and Drug Administration (“FDA”) obtained a court order from the United States District Court for the Middle District of Georgia against a dietary supplement manufacturer. The Order prohibits the manufacturer from selling dietary supplements until they comply with FDA good manufacturing regulations and other applicable, federal requirements. In addition to purported manufacturing deficiencies, the Company, BioAnue, sold dietary supplements that were marketed as treatments for common diseases, causing the FDA to deem these products to be unapproved new drugs. The FDA’s announcement can be found here.

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@giannamore-law.com.FDA Attorney 150x150 Dietary Supplement Company Prohibited from Operations After Ignoring FDA Warning Letter

Aug 18

Permanent Injunction Sought after Cheese Manufacturer Fails to Respond to FDA Warning Letter

On August 8, 2014, the U.S. Food and Drug Administration (“FDA”) filed a Complaint for Permanent Injunction against a Michigan Cheese Manufacturer and its owners under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 332. The FDA seeks to prevent S. Serra Cheese Company, based in Clinton Township, Michigan from receiving, preparing, processing, packing, holding, or distributing food until they meet FDA requirements. The Complaint for Permanent Injunction comes as a result of inspectional observations and the Company’s failure to take prompt action when notified of these observations. In particular, FDA inspected the manufacturing facility in 2013 and found bacteria in its finished products and manufacturing facility that could cause potentially devastating harm to humans. They also found violations of monitoring and sanitations controls found in the “Good Manufacturing Practice” requirements for foods (21 CFR Sec. 110). The FDA’s announcement may be accessed here.

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@giannamore-law.com.

FDA Attorney 150x150 Permanent Injunction Sought after Cheese Manufacturer Fails to Respond to FDA Warning Letter

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