Continue reading »]]> 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.

Continue reading »]]> 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.

Continue reading »]]> 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. 

Continue reading »]]> 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.

Continue reading »]]> 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.

Continue reading »]]> 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.

Continue reading »]]> 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.

Continue reading »]]> 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.

Continue reading »]]> On January 24, 2013, the U.S. Food and Drug Administration (“FDA”) and the U.S. Federal Trade Commission (“FTC”) issued a joint warning letter to Flu & Cold Defense, LLC (“the Company”), a Florida company, for unlawfully marketing its “GermBullet” inhaler as a cold and flu remedy. The “GermBullet” is sold online as well as in small pharmacies and health food stores. You can read the warning letter here.

According to the text of the Warning Letter, the FDA targeted the Company, Flu & Cold Defense, along with its managing member Todd Whidden, for marketing the “Germ Bullet” as an unapproved new drug in violation of the Federal Food, Drug, and Cosmetic Act (“FDCA”). Flu & Cold Defense makes claims on its website, as well as in a recent press release, promoting its nasal inhaler as a remedy for the cold and flu viruses. Pursuant to the FDCA, products that are intended to be used in the diagnosis, cure, treatment or prevention of a disease or condition are considered drugs. 21 U.S.C. § 321(g). Unless the drug is generally recognized as safe and effective for its intended use, however, an application must be submitted to the FDA for approval before it can be marketed to consumers. The “GermBullet” has not yet been presented to the FDA for approval.

Additionally, the FDA notes in the Warning Letter that the “GermBullet” is misbranded pursuant to the FDCA because its labeling both fails to include adequate directions for its intended use and makes false and misleading claims. In particular, the Company’s website falsely states that an FDA recognized virology lab independently confirmed that the product has the potential capability to kill cold and flu viruses.

Finally, under the Federal Trade Commission Act, enforced by the FTC, it is unlawful to advertise that a product can prevent, treat, or cure human disease unless the advertisement is substantiated by competent and reliable scientific evidence indicating that the claims are true at the time they are made.

In all, both the FDA and FTC were involved in the issuance of this Warning Letter, highlighting the overlapping jurisdiction of the FDA and FTC with respect to product claims, and the importance of considering the requirements of both agencies in this context. The responsibilities of each agency are outlined in a Memorandum of Understanding, found here. The FDA has primary responsibility for regulating the labeling of food, drugs, devices, and cosmetics while the FTC has primary responsibility for regulating the advertising of food, over-the-counter drugs, non-restricted devices, and cosmetics.

The FDA and FTC frequently work together in situations where the same or similar claims are made in both labeling and advertising or when printed material, most often claims made on the internet, can be considered both labeling and advertising. Joint warning letters are rare, however, with the first only being issued in 2009.

For more information about compliance with both FDA and FTC regulations, please contact us at: contact@giannamore-law.com.

Continue reading »]]>
On January 25, 2013, the U.S. Food and Drug Administration (“FDA”) announced the approval of the first women’s bladder control product available without a doctor’s prescription. In the past, all bladder control drugs were only available by prescription. This product, called Oxytol for Women, will be made available without a prescription for women aged 18 years and up only. Oxytol will remain available through a prescription only for men. The full story may be accessed here.

Overactive bladder, a condition where the bladder squeezes too often or without warning, affects up to 33 million Americans annually, and the majority of the afflicted are women.  The active ingredient in the Oxytol is called Oxybutynin, which belongs to a class of drugs known as anticholinergics.  It has the distinction of being the first drug from this class made available for over the counter treatment (“OTC”) for overactive bladder. 

When the original Federal Food, Drug and Cosmetic Act was enacted in 1938, there was no clear distinction between OTC drugs and prescription drugs. It was not until 1951, with the passage of the Durham-Humphrey amendments, that this issue was addressed and specific standards for classification of OTC drugs were created. The Durham-Humphrey amendments required that drugs that are not likely to be used safely without supervision from a doctor be dispensed by prescription only.  These prescription-only drugs were essentially deemed unsafe as they were believed to be habit-forming, toxic, have the pote

ntial for harmful side effects, or are for the treatment of maladies that cannot be diagnosed by a layman. The Durham-Humphrey amendments also provided that all other drugs that do not meet the criteria for unsafe drugs can be sold OTC.

The process of taking a drug from prescription to OTC status is called an “Rx to OTC switch.” This switch can happen in two ways, either by a manufacturer’s submission of additional information about the drug or by an “OTC drug review.” In 1972, OTC drug review began in order to review on an ongoing basis the safety and effectiveness of all drugs that are permitted for non-prescription use.  Through the OTC drug review process, experts in the field then will review the active ingredients to determine if they are indeed safe and effective. The second way a drug is approved for OTC use is through the new drug application process. Under this process, the manufacturer must submit information to the FDA that clearly shows the drug is appropriate for self-administration. Often, the information will include the submittal of studies showing that the product label can be easily read and understood by the consumer without the aid of a healthcare professional. More information about the Rx to OTC switch process may be accessed here.

If you have additional questions with Rx to OTC switch process or the FDA’s regulation of drugs, please contact us at contact@giannamore-law.com.

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