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.

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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

May 06

FDA to Regulate New Tobacco Products, E-Cigarettes

On April 24, 2014, the U.S Food and Drug Administration (FDA) announced its publication of newly proposed regulations pertaining to new tobacco products, as permitted by the Family Smoking Prevention and Tobacco Control Act of 2009. The products covered under the newly-proposed regulations are any tobacco related products that fall under the statutory definition of tobacco products, including presently uncontrolled, advertised products like pipe tobacco, electronic cigarettes (e-cigarettes), nicotine gels, water pipe tobacco, cigars and other related products. While some products, like electronic cigarettes, don’t directly consist of tobacco, these products fall under FDA’s tobacco authority, as promulgated by Congress, in that they are derived from tobacco and/or contain nicotine, i.e., e-cigarettes contain nicotine derived from tobacco and therefore meet the definition of tobacco product under federal law. Currently, the FDA’s final regulations only cover smokeless tobacco, cigarettes, rolling tobacco and cigarette tobacco. More information about the FDA’s announcement may be found here.

Similar to tobacco products previously regulated by the FDA, the new regulations would require product manufacturers and marketers, including marketers of e-cigarettes, to follow certain guidelines, such as the following:

  • FDA registration and reporting of product information
  • Certain new tobacco products can only be marketed after a full FDA review
  • Free samples cannot be distributed
  • Only scientifically proven, direct claims of a decreased health risk, i.e., “smoking e-cigarettes is safer than traditional cigarettes”,  can be made where the FDA is able to verify that the evidence meets a certain level of scientific support

Additionally, the new proposed rules will include certain restrictions on newly-regulated tobacco related products, including e-cigarettes, that apply to marketing and sale of previously-regulated tobacco products, such as the following:

  • Product packaging must list health warnings
  • Identification and minimum age requirements in order to prevent underage purchases
  • Products cannot be sold in vending machines unless the machine is located in a facility does not allow underage youths

The full text of the proposed regulations may be accessed here.

Although new tobacco products like e-cigarettes are not subject to current, final regulations pertaining to other tobacco products, the agency is working hard to gain control over these items, as illustrated through the proposed rule. If and when the regulations pertaining to e-cigarettes and other new tobacco products are finalized, importers and marketers of these products will be required to comply with the various requirements in order to ensure that their products may be marketed in a manner consistent with federal law. Accordingly, product registration and changes in marketing, including revisions to current labeling for e-cigarettes and the like, may be necessary in order to continue doing business in the United States.

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

FDA Attorney 150x150 FDA to Regulate New Tobacco Products, E Cigarettes

Apr 28

FDA Publishes Draft Guidance on Honey Labeling

On April 11, 2014, the U.S. Food and Drug Administration (“FDA”) published a draft guidance document, entitled “Draft Guidance for Industry: Proper Labeling of Honey and Honey Products” (“Guidance”). The Guidance provides industry with guidelines on how to properly label honey and related products in order to ensure that these products are not labeled in a misleading manner pursuant to the requirements of the Federal Food, Drug and Cosmetic Act (“FFDCA”) and accompanying FDA regulations.

The Guidance sets forth the Agency’s current thinking pertaining to honey labeling. In particular, the FDA notes the proper uses of the term “honey” in labeling and notes that labelers may state the name of the source of honey, such as plant or blossom, depending on whether this source is the chief floral source of the honey. More information about the labeling of honey can be found here.

In addition to honey labeling issues, the FDA monitors the importation of honey and honey products to check for adulteration caused by the addition of corn sugars and sugar cane. Under sections 402(b)(1) through 402(b)(4) of the FFDCA, a food is considered to be adulterated if an important component has been withheld from a food, any element has been fully or partially replaced or a component has been added to the food in order to inflate the weight or size, decrease quality or to make it seem superior in quality. Accordingly, products labeled as honey that contain added corn sugars, sugar cane or other substances would not be released into American distribution until the FDA finds that the honey has not been adulterated.

In sum, in order to import honey products without issue, industry is responsible for ensuring honey labeling is compliant with regulations and that honey products, as formulated, are not otherwise found to be adulterated under federal law. If you need assistance with honey labeling, importing or maintaining compliance with the laws and regulations enforced by the FDA, contact us at contact@giannamore-law.com.

FDA Attorney  150x150 FDA Publishes Draft Guidance on Honey Labeling

Apr 25

FDA Advises Consumers to Avoid Using Dietary Supplements with Undeclared Drug Ingredients

On April 7, 2014, the U.S. Food and Drug Administration (“FDA”) advised consumers to stop taking Zi Xiu Tang Bee Pollen products, which are promoted as body forming, weight loss dietary supplements. According to the FDA, the Company’s dietary supplements include at least one potentially dangerous pharmaceutical ingredient that is not declared on the product label. After testing a variety of different Zi Xiu Tang Bee Pollen dietary supplements, the FDA has discovered that each product contained at least one of the listed unnamed drug ingredients:

Phenolphthalein – A substance that is associated with cancer and is not a current ingredient in any accepted drug in the country.

Sibutramine – A controlled substance that has been deemed unsafe by the FDA and was removed from the market in October 2010. Sibutramine is a recognized substance that has been known to dramatically raise blood pressure levels in certain patients and has been known to introduce a powerful risk for people that have a history of congestive heart failure, stroke, coronary artery disease or arrhythmias.  More information can be found here.

In the past, the FDA has issued statements to consumers and industry concerning the presence of undeclared active ingredients in dietary supplements. The Agency has found that although these products are often being marketed as dietary supplements, the presence of undeclared active ingredients causes them to be classified as unapproved new drugs under the Federal Food, Drug and Cosmetic Act (“FFDCA”).

Further, in alleging that these ingredients may be dangerous, the Agency noted it has received several serious adverse event reports that include extreme cardiac and other serious health issues. Some of the various negative health reports include suicidal thoughts, diarrhea, heart palpitations, tachycardia, chest pains, insomnia, seizures, anxiety and higher blood pressure levels. Additional information can be found here. These serious adverse event reports were collected as part of the industry’s regulatory burden and represent a part of the many responsibilities that industry must undertake in maintaining compliance with the laws and regulations enforced by the FDA. Under the FFDCA, manufacturers, packers and distributors of all dietary supplements  are required to report serious adverse events to the FDA within fifteen (15) business days and to provide the FDA with updates as to any medical information for the entire year following the initial report.

For more information about the FDA’s regulation of dietary supplements and industry’s regulatory burden with respect to the marketing and sale of dietary supplements, including how you may satisfy your adverse event reporting requirements, please feel free to contact us at contact@giannamore-law.com.

FDA Attorney 150x150 FDA Advises Consumers to Avoid Using Dietary Supplements with Undeclared Drug Ingredients

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