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

Aug 14

Gluten Free Labeling Now Being Enforced by FDA

On August 5, 2014, the U.S. Food and Drug Administration (“FDA”) regulations regarding “gluten free” labeling came into effect. Last year, on August 5, 2013, the FDA issued a final rule that effectively determined what characteristics a food must have in order to be considered gluten free and bear “gluten free” labeling. We reported about the final rule on gluten free labeling when it was issued exactly one year ago. Our previous report on the gluten free labeling rules may be accessed here.

FDA has authority to issue the rule defining gluten free and restricting gluten free labeling under Section 206 of the Food Allergen and Consumer Protection Act (FALCPA) of 2004. Under this provision, Congress directed the FDA to develop regulations pertaining to gluten free and “gluten free” labeling that will help protect consumers who suffer from celiac disease and related illnesses requiring a gluten free diet. The FDA Final Rule, which recently came into effect, defined “gluten free” as having less than 20 ppm (parts per million) of gluten. You can read the rule here. This definition includes foods that do not contain any of the following:

 1. An ingredient that is any type of wheat, rye, barley, or crossbreeds of these grains;

 2. An ingredient derived from these grains and that has not been processed to remove gluten, and

 3. An ingredient derived from these grains and that has been processed to remove gluten, if it results in the food containing 20 or more ppm of gluten.

21 C.F.R. § 101.91 (2014).

The full text of the Final Rule on gluten free labeling may be accessed here. Foods labeled “gluten free” “free of gluten” “without gluten” and “no gluten” have to comply with this requirement as well. However, the use of the “gluten free” labeling is voluntary. Foods that are gluten free in-fact are not required to bear “gluten free” labeling.

Any food with a manufacture date after August 5, 2014 will have to comply with this labeling requirement. However, the coast is not completely clear for consumers. Some food items that hit the marketplace prior to August 5 may still not be in compliance with this final rule. If foods are misbranded, meaning that they bear “gluten free” labeling and they are not in fact gluten free, then the manufactures and/or distributors of these foods are subject to regulatory action by the FDA pursuant to the Food, Drug, and Cosmetic Act (FDCA). These actions may include warning letters, detention upon importation, and other types of enforcement measures. More information about gluten-free labeling of foods is provided on the FDA’s website, accessible here.

If you are concerned that your product labeling may not be in compliance with the new requirements, it is important to take steps to ensure your compliance in order to avoid regulatory action. Federal regulatory enforcement actions can be time consuming and costly for a business, as they can result in time-consuming delays and even product recalls. If you have any questions about the final rule on gluten free labeling or compliance with FDA regulations, please contact us at: contact@giannamore-law.com.

FDA Attorney 150x150 Gluten Free Labeling Now Being Enforced by FDA

Jul 12

FDA Seeks Injunction against Company for Misbranding Drug Products

On June 25, 2014, the U.S. Department of Justice (“DOJ”), in response to a request made by the U.S. Food and Drug Administration (“FDA”), filed a complaint seeking a permanent injunction against Laclede, Inc. of Rancho Domingo California and the Company’s president, Michael A. Pellico. The injunctive relief, which was sought in the U.S. District Court for the Central District of California, related to Laclede’s illegal distribution of over-the-counter (OTC) vaginal drug products that did not have the required FDA approval. News pertaining to this action can be found here.

The unapproved products that were subject to the complaint against Laclede include: Luvena Prebiotic Vaginal Moisturizer and Lubricant; Luvena Prebiotic Enhanced Personal Lubricant; Luvena Prebiotic Feminine Wipes; and Luvena Prebiotic Daily Therapeutic Wash. Two separate inspections conducted at the company’s Rancho Domingo facility, dated June 19 and June 27, 2012, found that the products listed did not have proper identification and strength listings for the active ingredients of those products, in violation of Title 21, Code of Federal Regulations, Parts 211 [21 CFR §211.165(a)] of the Act. Subsequent to the inspections the FDA sent a warning letter, dated February 14, 2013, which informed the Company that they both failed to take corrective actions regarding their testing procedures, and that based on the current labeling and marketing of the products, the FDA found the products to be classified as “unapproved and misbranded” drugs.

Based on the claims made by the Company on its product labels, inserts and website, the products were found to be in violation of the Federal Food, Drug and Cosmetic Act. Discovered during facility inspections and later the subject of a warning letter, these deficiencies were not corrected, despite several notifications from the FDA. Accordingly, the present action was taken against Laclede, as the Company failed to take corrective actions in response to numerous warnings by the FDA. Had the company heeded the repeated warnings posed to them by the FDA and made appropriate changes to the branding of their products, they may have been able to avoid further action. Any company that has received notice regarding the misbranding of products should take appropriate action as soon as possible to reduce the risk of further penalties.

If you have any questions about how you can maintain compliance with FDA regulations, please contact us at contact@giannamore-law.com.

FDA Attorney 150x150 FDA Seeks Injunction against Company for Misbranding Drug Products

Jul 02

FDA Warning Issued Regarding Weight Loss Products

On April 7, 2014, the U.S. Food and Drug Administration (“FDA”) released an advisory, warning consumers not to use bee pollen capsule marketed under the name Zi Xiu Tang Bee Pollen. The purpose for the advisory, previously reported here, was to alert the public that the product contained potentially harmful active pharmaceutical ingredients, which had not been listed on the label for the product and was the subject of a FDA warning letter.

The undeclared substances, Sibutramine Hydrochloride (sibutramine), an active ingredient in the obesity drug Meridia (pulled from the United States market in December 2010 based on increased risk for stroke and heart attack in users), and Phenolphthalein, an inactive ingredient linked to cancer risk, were found in multiple test samples from various distributors. The FDA warning letter was issued to manufacturers of Zi Xiu Tang Bee Pollen, threatening that seizure of product and criminal prosecution measures would be taken should they refuse to comply with proper labeling under FDA guidelines. Despite this warning, manufacturers and distributors of Zi Xiu Tang Bee Pollen continued its marketing and labeling practices, resulting in the FDA issuing an Import Alert to ban the product’s entry into the US market. Further action, if warranted by the FDA, may include the issuance of additional warning letters to the company and heightened enforcement action, including product seizures, injunctions and possible criminal charges.

The problem of undeclared ingredients in weight loss supplements and other products, drug ingredients or otherwise, is taken very seriously by the FDA. As evidenced by the February 14, 2013 raid of Globe All Wellness, LLC by U.S. Marshals acting on behalf of the FDA, the measures taken to uphold the requirements of the Federal Food, Drug and Cosmetic Act (FFDCA) can be severe. FDA warning letters, product recalls and seizures, and ultimately criminal prosecution can occur where noncompliance with these requirements is found. Companies, including manufacturers, or distributors of products that have received a warning letters from the FDA should take these issues seriously and take steps towards achieving compliance in order to avoid heightened scrutiny and enforcement by the FDA.

If you have any questions about the FDA warning letters and how you can maintain compliance with regulations pertaining to the labeling and marketing of these products, please contact us at contact@giannamore-law.com.

FDA Attorney 150x150 FDA Warning Issued Regarding Weight Loss Products

Jun 11

FDA Publishes Food Allergen Labeling Guidelines

On May 8, 2014, the U.S. Food and Drug Administration (FDA) published its “Draft Guidance for Industry: Food Allergen Labeling Exemption Petitions and Notifications.” The draft guidance represents current thinking on the topic as previously discussed through the release of the October 2006 “Guidance for Industry: Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 4); Final Guidance.” The guidance provides the FDA’s answers to commonly asked questions concerning the notification process for those seeking exemptions from the labeling of food allergens and updates the responses in the 2006 document. You can read the draft guidance on the FDA’s website, available here.

Major food allergens are defined in section 201(qq) of the Federal Food, Drug, and Cosmetic Act (FFDCA) as “[m]ilk, egg, fish (e.g., bass, flounder, or cod), Crustacean shellfish (e.g., crab, lobster, or shrimp), tree nuts (e.g., almonds, pecans, or walnuts), wheat, peanuts, and soybeans” and also as any food ingredients that contain protein derived from these foods. This definition currently excludes highly refined oil that has been derived from a major food allergen and any ingredient derived from such highly refined oil. The term “major food allergen” was first defined in the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) (Title II of Public Law 108-282), which was incorporated into and amended the FFDCA.

Exemptions from the food allergen labeling requirements as found in section 403(w)(1) of the FFDCA, as amended by FALCPA, must be done through a petition and notification process. Such process includes a declaration by the petitioner that the ingredient for which exempted relief is being sought does not cause an allergic reaction, pose a significant risk to human health, or contain an allergenic protein. However, as explained in the guidance document, manufacturers of such products that wish to claim the exemptions must submit detailed petitions to the FDA before omitting major allergen labeling.

Understanding how to properly label foods with the necessary food allergen labeling information is important. Products that are improperly labeled (i.e. contains an undeclared allergen) often result in recalls and enforcement actions by the FDA. More information the consequences of failure to declare allergens in labeling may be accessed here.

If you have any questions about food labeling, including compliance with FDA requirements pertaining to major food allergen labeling, please contact us at: contact@giannamore-law.com.FDA Attorney 150x150 FDA Publishes Food Allergen Labeling Guidelines

May 28

FDA Seizes Topical Creams Deemed Drugs

On May 16, 2014, the U.S. Food and Drug Administration (“FDA”), with assistance by the U.S. Attorney for the Southern District of Ohio, seized unapproved drugs valued at more than $11 million, which were marked by Ascend Laboratories of Montvale, N.J. and held by Masters Pharmaceuticals, Inc. of Cincinnati, OH. The products seized by the FDA included those marketed for the treatment of inflamed hemorrhoids, colitis and other inflammatory conditions (Hydrocortisone Acetate Suppositories, 25 mg) and skin thickening conditions such as dermatitis and eczema (Urea Cream 39%, Urea Cream 40% and Urea Lotion 40%). The FDA announcement can be found here.

The action taken against Ascend Laboratories and Masters Pharmaceuticals (“the Companies”) was taken as a follow up to a November 2013 inspection of Ascend, which found that these products had been marketed in the absence of an FDA-approved drug application. The inspection further found that these products were misbranded and were being sold contrary to the guidance provided by the FDA for the proper labeling and marketing of a drug or cosmetic.

The FDA took action by filing a complaint in the U.S. District Court for the Southern District of Ohio, citing that the Companies violated the provisions of the Federal Food, Drug and Cosmetic Act (“FFDCA”) found in Title 21, Code of Federal Regulations as promulgated under 21 U.S.C. 321 and 387. Under FFDCA and accompanying FDA regulations, products that intended to be used in the diagnosis, cure, treatment or prevention of a disease or condition are considered drugs. As noted in this case, the Companies marketed products for various diseases and/or conditions, including hemorrhoids, colitis and eczema. Further, while the FDA did not allege the products themselves contained active pharmaceutical ingredients, it was the statements made in marketing that caused the products to be deemed unapproved new drugs. Accordingly, it is important to ensure compliance with certain marketing limitations in order to avoid misbranding and other FDA violations.

In sum, this case illustrates the importance of ensuring that the marketing materials of FDA-regulated products, including websites, print media and product labels, are properly worded because statements made in marketing play a key role in determining how FDA-regulated products are regulated. Second, this case illustrates the importance of being responsive and remaining committed to taking all necessary corrective actions after deficiencies are alleged, as the Agency will pursue legal action for violations of the laws and regulations it enforces.

If you have any questions about the FDA’s food, drug and cosmetic regulations or how you can maintain compliance with these regulations, please contact us at contact@giannamore-law.com.

FDA Attorney 150x150 FDA Seizes Topical Creams Deemed Drugs

May 16

FDA Halts Production at New York Cheese Company

On April 28, 2014, the U.S. Food and Drug Administration (“FDA”) prevailed in federal court in its action against Nancy Taber Richards and the company she co-founded, Trumansburg, N.Y.-based Finger Lakes Farmstead Cheese Company, LLC. In particular, the Western District of New York’s U.S. District Court entered a consent decree of permanent injunction against the New York dairy manufacturer due to the detection of listeria contamination. News pertaining to the consent decree and prior warning letter can be found here.

According to the consent decree, the company Finger Lakes has been prohibited from the further manufacturing, preparation, processing, packaging, storage and distribution of food until evidence of a control program designed to eliminate the Listeria monocytogenes (“L. monocytogenes“) from both its production facilities and products. L. monocytogenes is a pathogen that can occur in various food products, causing sickness and fatalities.

The consent decree is the result of finger lakes failure to address deficiencies in its food processing operations, noted as recently as october 23, 2012 in a warning letter issued by the FDA. The warning letter issued by the FDA noted the company’s violation of the current good manufacturing practice regulation for food found in Title 21, Code of Federal Regulations, Part 110 [21 Cfr Part 110]. Additionally, the existence of the L. monocytogenes pathogen in ready-to-eat products produced by the company constitutes a violation of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. §342(a)(4)] with respect to the manufacture and sale of food products that contain a poisonous or deleterious substance that may be harmful to the public’s health.

Finger Lakes had been warned by the FDA on several occasions regarding the unsanitary conditions within the company’s facilities that led to the Listeria contamination. Laboratory testing in both 2012 and 2013 uncovered the existence of the L. monocytogenes pathogen and led the FDA to take action pursuant to its regulatory authority under federal law. Warning letters are typically FDA’s first course of action against parties deemed noncompliant with federal regulations and are a type of informal agency action that is used to signal the possibility of future enforcement should the alleged deficiencies not be remedied. Thus, it is important to take warning letters seriously and complete any necessary corrective actions in order to thwart the possibility of further agency action.

If you have any questions about the FDA’s food product safety regulations, warning letters, or how you can maintain compliance with FDA regulations, please contact us at contact@giannamore-law.com.

FDA Attorney 150x150 FDA Halts Production at New York Cheese Company

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