Jun 03

FDA Issues Final Rule on Prior Notice for Imported Food

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FDA

On May 29, 2013, the U.S. Food and Drug Administration (FDA) issued a final rule that adopts, without change, the Interim Final Rule (IFR), entitled “Information Required in Prior Notice of Imported Food,” that was published in the Federal Register (76 FR 25542) on May 5, 2011. In particular, the final rule adopts the IFR’s requirement that a prior notice of imported food for humans or animals include the name of any country to which the article has been previously refused entry. You can read the final rule here.

Pursuant to section 801(m) of the Federal Food, Drug, and Cosmetic Act (FDCA), as amended by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, an article of food imported or offered for export may be refused admission into the United States if adequate prior notice has not been provided. 21 CFR §1.281 explains the information that must be submitted in a prior notice. The 2011 IFR and final rule now require a party submitting a prior notice to report the name of any country to which an article of food has been refused entry. While, the FDA currently requires that only the identity of the country and not the reasons for the refusal be submitted, other information could be required on a case-by-case basis. As noted in the preamble to the final rule, the FDA, after reviewing the prior notice, may request that the submitter provide additional information.

According to the FDA, only refusals of entry or admission that are based on food safety reasons must be reported in a prior notice. The agency is primarily concerned with identifying foods that present a health risk to consumers. However, as we have seen with most regulatory authority and interpretations thereunder, “public health” has been interpreted very broadly. In sum, when there is a violation of the prior notice regulations, the FDA will take the totality of the circumstances into account in deciding whether to enforce the violation. For example, it will look at the severity of the violation and any previous violations, particularly if they were similar.

You can read more about the FDA’s guidelines for the prior notice of imported foods here. If you have any questions about prior notice requirements or how a FDA regulatory attorney can help you comply with the FDCA and accompanying FDA regulations, please contact us at: contact@giannamore-law.com.

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May 29

FDA Issues Letter for Failure to Obtain 510(k) Clearance for Medical Mobile App

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FDA

On March 21, 2013 the U.S. Food & Drug Administration (FDA) issued an “It Has Come to Our Attention Letter” to Biosense Technologies Private Limited for failure to obtain 510(k) clearance for its medical mobile app, uChek Urine Analyzer. The uChek Urine Analyzer is an iPhone mobile app, intended for use with Siemens and Bayer reagent strips, which allows a mobile phone to analyze the strips and determine urine analytes. You can read the letter here.

In the letter, the FDA explains that urinanalysis dipsticks are cleared only when they are interpreted by a direct visual reading. Any company intending to market a device for automated reading of the dipsticks must obtain clearance for the reader and the test strips as used together. In this case, Biosense is required to either identify an FDA clearance for the medical mobile app or provide an explanation as to why it does not believe that additional 501(k) clearance is necessary. According to the terms of the Letter, the company must submit the requested information to the FDA within 30 business days.

The FDA currently regulates medical mobile apps on a case-by-case basis. In the agency’s Draft Guidance–Medical Mobile Applications, a medical mobile app is defined as a software application that meets the definition of a device pursuant to section 201(h) of the Federal Food, Drug, and Cosmetic Act (FDCA) and is either used as an accessory to a regulated medical device or transforms a mobile platform into a regulated medical device. Specifically, a mobile app is a medical device when it is intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease or other condition or is intended to affect the structure or any function of the body.

In sum, the FDA requires medical device manufacturers and/or marketers, including those manufacturing and marketing mobile medical apps, to submit a premarket notification, also known as a 510(k), 90 days in prior to marketing unless the device is otherwise exempt from these requirements. More information about the pre-market notification process can be found here or at our previous post here. If you have any questions about obtaining a 510(k) clearance or the regulation of medical mobile applications, please contact us at contact@giannamore-law.com.

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May 07

FDA Investigates the Safety of Caffeine in Food

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FDA

On May 3, 2013, the U.S. Food and Drug Administration (FDA) announced that it is currently investigating the safety of added caffeine in foods, particularly in response to a recent trend of caffeinated products. The FDA is primarily concerned with the consumption of caffeine by children and adolescents, and in turn, caffeine in food products marketed to these age groups. You can read the FDA’s article here.

According to the article, the FDA will address the health effects of caffeine, especially for those at risk from excess consumption. It will also look at the appropriate products for added caffeine and might eventually decide to limit the amount of caffeine in foods, particularly those that are marketed to children and adolescents. One concern with caffeine in foods is that caffeine is being added in excess of its traditional use levels, which raises the question of whether these higher levels are safe. The FDA currently lists 400 milligrams of caffeine, or 4 or 5 cups of coffee a day, as a safe level for healthy adults.

Caffeine is explicitly approved as an additive by the FDA only in cola-type beverages. This does not preclude the use of caffeine in other foods at safe levels, however. Pursuant to section 409 of the Federal Food, Drug, and Cosmetic Act (FDCA), a substance that is intentionally added to a conventional food, which is consumed for taste, aroma, or nutritive value, is considered unsafe unless its use has been pre-approved by the FDA or it is generally recognized as safe (GRAS) by qualified experts. This means that manufacturers can add an ingredient, such as caffeine, to a conventional food if they make the determination that it is GRAS for its intended use.

Additionally, many manufacturers market caffeinated products as dietary supplements rather than conventional foods. Under the Dietary Supplement Health and Education Act (DSHEA), a dietary supplement is a product taken by mouth that contains a dietary ingredient and is intended to supplement the diet. The regulations for added ingredients in dietary supplements are different than those for conventional foods. Dietary ingredients marketed prior to 1994, such as caffeine, intended for use in a dietary supplement are presumed safe, for example. This means that they do not require premarket approval or a GRAS determination.

In all, the FDA is authorized to take enforcement actions against any products that it considers to be unsafe. In 2010, for example, the Agency withdrew certain caffeinated alcoholic beverages from the market due to health-related risks. If you have any questions about the FDA regulation of caffeine in foods or need the assistance of a FDA regulatory attorney, please contact us at: contact@giannamore-law.com.

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Apr 29

FDA Issues Warning Letters to Online Cigarette Companies

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FDA

In April 2013, the U.S. Food and Drug Administration (FDA) issued warning letters to certain online cigarette retailers, finding many of their products adulterated and misbranded in violation of the Federal Food, Drug, and Cosmetic Act (FDCA). One of the companies is located in Indonesia but offers its cigarettes for sale to customers in the United States. It is unclear where the other company is based, as it is an internet retailer with no available address information. You can read the warning letters by clicking here and here. The FDA sent similar warning letters to other online retailers of cigarettes earlier this year.

In the warning letters, the FDA explains that the companies are required to immediately correct the violations. Also, they have 15 working days from the date that they received the warning letters to submit a written response to the agency. The response must describe all corrective actions that the company has taken to bring their cigarette products and advertisements into compliance with the FDCA and accompanying FDA regulations, especially the Family Smoking Prevention and Tobacco Control Act (FSPTCA), which gives the FDA jurisdiction over the manufacturing, distribution, and marketing of tobacco products.

In particular, after reviewing the companies’ websites, the FDA found that several cigarette products were adulterated under section 902(8) of the FDCA because they are were marketed as modified risk tobacco products without FDA approval. According to section 911(b)(2)(A), a product is considered a modified risk tobacco product if its labeling or advertising represents that the product contains a reduced level of a substance or uses the descriptors light, mild, or low. For example, certain cigarettes were labeled as containing reduced levels of tar and nicotine. A modified risk tobacco product cannot be marketed without an FDA order pursuant to section 911(g). Otherwise, it is adulterated in violation of the FDCA.

Additionally, the FDA notes that many of the cigarettes are either adulterated or misbranded because they are marketed as flavored cigarettes in violation of the FDCA as amended by the FSPTCA. Under section 907(a)(1)(A), a cigarette or any of its components shall not contain a natural or artificial flavor, other than tobacco or menthol, as a constituent or additive that is a characterizing flavor. Cigarettes marketed and sold in violation of this provision are considered adulterated.  Otherwise, if the cigarettes do not actually contain a characterizing flavor, they are misbranded as their labeling or advertising is false or misleading.

More information about the requirements for selling a modified risk tobacco product can be found here. If you have any questions about FDA regulations regarding the marketing of tobacco products or need a FDA attorney to help you respond properly to warning letters, please contact us at contact@giannamore-law.com.FDA Attorney 150x150 FDA Issues Warning Letters to Online Cigarette Companies

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Apr 09

FDA Publishes CPG on Food Facility Registration

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On April 4, 2013, the U.S. Food and Drug Administration (FDA) published its Draft Compliance Policy Guide Sec. 100.250 Food Facility Registration—Human and Animal Food. This compliance policy guide, when finalized, will provide a resource to FDA staff on the requirements of food facility registration under Section 415 of the Federal Food, Drug, and Cosmetic Act (FDCA) and aid the Agency in determining whether parties subject to food facility registration are compliant with all applicable laws and regulations. The draft is available here.

Section 415 was added as an amendment to the FDCA by Section 305 of the Public Health, Security, and Bioterrorism Preparedness and Response Act of 2002. It primarily establishes the requirement that the owner, operator, or agent of a domestic or foreign food facility, as defined by 21 CFR 1.227, where food is manufactured, packed, or held for human or animal consumption, complete food facility registration with the FDA. Failure to maintain such food facility registration, regardless of whether the food actually enters interstate commerce, is prohibited under Section 301(dd) of the FDCA. Applicable exceptions to this requirement are listed in 21 CFR 1.226.

The Food Safety and Modernization Act (FSMA), enacted on January 4, 2011, added additional requirements to Section 415 and the requirements pertaining to food facility registration. Registration applications, for example, must include the email address of the contact person for a domestic facility, the email address of a US agent for a foreign facility, and a guarantee that the FDA will be permitted to inspect the facility as authorized by the FDCA.

Additionally, Section 415 (a)(3), as amended by the FSMA, requires that a food facility registration be renewed by the FDA biennially. More specifically, any food facility that previously registered with the FDA must submit a renewal from October 1 to December 31 of each even numbered year. An abbreviated process is available when no changes have been made to the previously submitted application. The FDA will consider the facility to have failed to comply with the mandatory food facility registration if its registration is not renewed.

Finally, Section 415(b) authorizes the FDA to suspend a facility’s food facility registration under certain circumstances. Particularly, if the FDA finds that food manufactured, processed, packed, received, or held at a registered facility has a reasonable probability of causing serious adverse health consequences to humans or animals, the FDA will suspend the registration of the facility. If a facility with a suspended registration, moreover, introduces food from the facility into interstate or intrastate commerce in the United States, it will be subject to an appropriate enforcement action by the FDA.

In sum, the comment period for the draft ends on May 6, 2013. You can read more detailed information about food facility registration here. If you have any questions about compliance with the food facility registration requirements or how a FDA regulatory attorney may help you, please contact us at: contact@giannamore-law.com. FDA Attorney 150x150 FDA Publishes CPG on Food Facility Registration

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Mar 14

Company’s Operations Halted for Violating FDA Food Labeling Rules

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FDA

On March 13, 2013, the U.S. Food and Drug Administration (“FDA”) announced that a federal judge has signed a consent decree of permanent injunction, enjoining a New Jersey-based food company’s operations. In particular, Butterfly Bakery Inc. (“the Company”) is prohibited from processing and distributing food until it brings its operations into compliance with the Federal Food, Drug and Cosmetic Act (“FFDCA”). According to the consent decree, the Company’s products were deemed misbranded due to various labeling deficiencies, whereby the Company allegedly failed to comply with federal law and accompanying FDA food labeling rules.

As noted by the FDA, the present action demonstrates the agency’s willingness to take enforcement action against companies that “. . . mislead consumers on the products they purchase.” Interestingly, the alleged misleading conduct was in no way related to efficacy or therapeutic claims, frequently seen as prompting enforcement actions. Rather, the deficiencies cited in the present case were limited to allegations of improper nutrient content claims. For example, and among other allegations, the FDA alleged the Company’s products bore “sugar free” claims when in fact these products contained sugar.

Under the FFDCA and accompanying FDA food labeling rules, foods must be labeled accurately or they run the risk of being deemed misbranded by the FDA. As demonstrated in the present case, failure to label food in accordance with federal law and regulations may lead to enforcement action, including costly and time-consuming halts to manufacturing and distribution processes. Accordingly, it is important to ensure that the labels of all food products that are marketed and sold in the United States are in compliance with FDA regulations.

For more information about FDA food labeling rules or how you can ensure compliance with the laws and regulations enforced by the FDA contact us at contact@giannamore-law.com.

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Mar 08

Supreme Court to Review Design Defect Case against Generic Drug Company

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FDA

On March 19, 2013, the U.S. Supreme Court will hear arguments in Mutual Pharmaceutical Company, Inc. v. Karen L. Bartlett. The defendant-appellant in the case, Mutual Pharmaceutical Company (“Mutual”) appealed from a decision of the U.S. Court of Appeals for the First Circuit, in Karen L. Bartlett v. Mutual Pharmaceutical Company, Inc., 678 F.3d 30 (1st Cir. 2012), where the Court found that the Federal, Food, Drug, and Cosmetic Act (“FDCA”) does not preclude a state law design defect claim against a generic drug manufacturer. You can find the documents in the case here.

Mutual is a Pennsylvania company that markets sulindac tablets, an anti-inflammatory drug. Sulindac tablets are the generic version of the brand-name drug Clinoril. Ms. Bartlett suffered permanent injuries after taking the sulindac tablets, and brought a design-defect lawsuit against Mutual pursuant to New Hampshire state law. The district court awarded compensatory damages to Ms. Bartlett. Mutual appealed, and the U.S. Court of Appeals for the First Circuit affirmed the district court’s decision. The Supreme Court granted certiorari on November 30, 2012.

Mutual markets the sulindac tablets under an Abbreviated New Drug Application (“ANDA”) that was approved by the U.S. Food and Drug Administration (“FDA”) in 1991. Unlike a New Drug Application (“NDA”), an ANDA does not require that a drug sponsor submit any preclinical or clinical testing data. All generic drugs under an ANDA, however, must be bioequivalent, or chemically identical, to an innovator drug already approved by an NDA.

Of primary focus in this case is whether states are allowed to impose liability on a generic drug manufacturer for a defective design. In a similar case, PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), the Supreme Court held that federal law precludes a state failure-to-warn claim against generic drug products because FDCA regulations require that a generic drug has the same label as the brand name drug. Since a generic drug manufacturer is not allowed to alter a drug’s label, the court found that a company would be unable to comply with the state duty to warn without violating federal law.

Mutual argues that Mensing is applicable to design-defect claims as well. According to Mutual, the FDCA requirement that a generic drug product be the bioequivalent of the brand name drug, with identical active ingredients, precludes any design-defect lawsuits targeting generic drugs.

Ms. Bartlett argues, and the First Circuit agreed, however, that Mensing is not applicable to design-defect claims. Previously, in Wyeth v. Levine, 555 U.S. 555 (2009), the Supreme Court held that the FDCA does not preempt a state law failure-to-warn claim against a brand name drug. The First Circuit’s opinion explains that the later holding in Mensing only requires an exception for a failure-to-warn allegation against a generic drug. Additionally, according to the court, a generic drug manufacturer can avoid liability by not making the product if the risk outweighs the benefits to consumers.

In sum, the Supreme Court is not expected to issue an opinion in the case until June. If you have any questions about the requirements for generic drugs or the drug approval process, please contact us at contact@giannamore-law.com.FDA Attorney 150x150 Supreme Court to Review Design Defect Case against Generic Drug Company

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Feb 26

FDA Approves Orphan Drug to Treat Aplastic Anemia

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FDA

On February 21, 2013, the U.S. Food and Drug Administration (“FDA”) granted orphan drug status to an aplastic anemia treatment. Aplastic anemia is a rare condition where bone marrow does not produce sufficient blood cells or platelets. The treatment, placental expanded (PLX) cells, is sponsored by Pluristem Therapeutics, Inc. You can read more about the requirements for obtaining orphan drug status here.

Pursuant to the Orphan Drug Designation program, the FDA provides incentives for the development of products that will diagnose or treat rare diseases. Orphan drug status qualifies a drug sponsor to receive tax credits for clinical testing of the product and other marketing benefits. Otherwise, because it is intended to treat a rare disease, the development of the drug might not be profitable and such rare diseases may never be treated.

To qualify for orphan drug status under FDA regulations, the drug or biologic product must be intended to treat or diagnose a rare disease or condition affecting fewer than 200,000 people per year in the United States. 21 C.F.R. part 316. Additionally, an application must be submitted by the sponsor, and thereafter approved by, the FDA Office of Orphan Products Development.

If you have any questions about the Orphan Drug Designation program or FDA’s regulations of drugs, please contact us at contact@giannamore-law.com.

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Feb 21

Food Seasonings Recalled Due to Undeclared Allergens

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FDA

On February 15, 2013, the DeCoty Coffee Company of San Angelo, Texas announced that it was recalling its 1.25 pound and 5.75 pound DeCoty Taco Seasoning products. Prompting this recall are labeling concerns, specifically that the products contain an undeclared ingredient, soy, and people who have allergies or sensitivity to soy may run the risk of a serious allergic or life threatening reaction if they consume this product. As of this date, no illnesses have been reported due to ingesting this product. More information about the recall may be accessed here.

In 2004, Congress passed the Food Allergen Labeling and Consumer Protection Act (FALCPA) to help Americans avoid health risks posed by allergens. This law applies to all foods whose labeling is FDA-regulated, and it includes all domestically-produced and imported foods, including dietary supplements. Under FALCPA, any food product that contains a major food allergen or a protein derived from a major food allergen must declare the presence of such ingredient on the product’s label. Further, the eight major food allergens are defined under FALCPA as: (1) milk; (2) egg; (3) fish; (4) crustacean shellfish; (5) tree nuts; (6) wheat; (7) peanuts, and (8) soybeans. More information about FALCPA and FDA’s regulation of major food allergens in labeling may be accessed here.

If you have additional questions about food allergen labeling requirements or how you can maintain compliance with FDA labeling regulations, please contact us at contact@giannamore-law.com.

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Feb 20

Marshals Seize Supplements with Undeclared Drug Ingredients

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FDA

On February 14, 2013, U.S. Marshals, acting on behalf of the U.S. Food and Drug Administration (FDA), raided the headquarters of Globe All Wellness, LLC, a dietary supplement manufacturer based in Hollywood, Florida. Marshals seized what are alleged to be tainted dietary supplements, believing the products to be unsafe, as they may contain an undisclosed active pharmaceutical ingredient. Marshals noted that several of the products that were seized contain sibutramine hydrochloride (sibutramine), which is the active ingredient in Meridia, an obesity drug. Meridia was pulled from the market in the United States in December of 2010, after clinical trials determined the drug increased the risk of stroke and heart attack in users. You can read the complete press release here. 

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

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

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

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

If you have questions about FDA regulations regarding the manufacturing, distribution and marketing of dietary supplements, please contact us at contact@giannamore-law.com.

FDA Attorney 150x150 Marshals Seize Supplements with Undeclared Drug Ingredients

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