Mar 19

FTC Prevails Against Marketers of Medical Foods

On March 7, 2014, the Federal Trade Commission (“FTC”) reported that the Agency had prevailed in federal court in its action against the Wellness Support Network. In particular, the U.S. District Court for the Northern District of California entered a final judgment, finding that Wellness Support Network had violated Section 5 of the Federal Trade Commission Act (“FTCA”) by making claims about its products that were considered false and/or unsupported by scientific evidence at the time the claims were made. As part of its judgment, the Court ordered the Company to pay nearly $2.2 million dollars in restitution, which will in turn be used by the FTC to reimburse consumers who relied on these marketing claims and purchased the products. The full report from the FTC may be accessed here.

Marketers of the diabetes products Insulin Resistance and Diabetic Pack, Wellness Support Network (“the Company”), attempted to market their products as medical foods. However, both the FTC and FDA took issue with the Company’s statements in advertising and targeted the Company in connection with the marketing of these products. In particular, in September 2005 and October 2006, the FDA issued two separate warning letters to the co-owners of Wellness Support Network, Robert and Robyn Held, warning the Company that their products, as advertised, were deemed unapproved drugs by the FDA. When the Helds did not stop marketing their products, the FTC then stepped in and ultimately filed a complaint for permanent injunction in federal court, arguing that the Company’s advertising claims pertaining to diabetes were deceptive, in that the representations made about the products were false and/or were not supported by the requisite level of substantiation when made.

In sum, 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. Where, the FDA has primary responsibility for regulating the labeling of food, drugs, devices, and cosmetics, the FTC has primary responsibility for regulating the advertising for these types of products. Accordingly, compliance with both regulatory authorities is essential. For more information about compliance with both FDA and FTC regulations, please contact us at: contact@giannamore-law.com.

FDA Attorney  150x150 FTC Prevails Against Marketers of Medical Foods

Mar 18

FDA Moves to Update Nutrition Facts Label for Foods

On February 27, 2014, the U.S. Food and Drug Administration’s (“FDA”) moved to update nutrition facts labels (“Nutrition Facts Panels”) on packaged foods and dietary supplements. The proposal was prompted by recent scientific findings that suggest there is a direct correlation between excessive food intake and recurring diseases, like heart disease and obesity. In addition, the proposed labeling will replace outdated serving sizes to help deliver a better perception of actual food intake by consumers today. The proposed Nutrition Facts Panels will provide a new, unique approach that highlights certain parts of the label like serving sizes, ingredients and caloric intake. A complete The FDA press release, explaining this proposal can be accessed here.

Recommending the change, the FDA’s proposal will impact the labels of foods and dietary supplements throughout the United States. First established 20 years ago, nutrition facts labels assist consumers with making knowledgeable food choices and provide a uniform means of displaying information to consumers. If implemented, the new nutrition facts label would include amended serving size specifications, differing label requirements for some package sizes, and an updated design. Additional information about current nutrition facts labels and the proposed changes to nutrition facts labels can be accessed here.

Without question, ensuring compliant labeling of foods is important for manufacturers and sellers of foods and dietary supplements doing business in the United States. For example, FDA often detains shipments of foods and dietary supplements upon being offered for importation solely  for failure to comply with labeling requirements. Accordingly, keeping abreast of all changes to the regulations pertaining to nutrition facts labels is critical in order to ensure implementation of any new regulatory requirements. If you have any questions pertaining to labeling of foods and/or dietary supplements and are in need of an FDA lawyer, please contact us at contact@giannamore-law.com.

FDA Attorney 150x150 FDA Moves to Update Nutrition Facts Label for Foods

Jan 21

FDA Issues Statement on IOM Report on Safety of Caffeine in Foods

On January 21, 2014, the U.S. Food & Drug Administration (“FDA”) issued a Statement on the Institute of Medicine’s Report (“IOM Report”) on Caffeine in Foods. Released on January 17, 2014, the IOM Report is a culmination of the recent public workshop, which took place in August 2013 and was focused on the investigation of the continued safety of caffeine in foods and dietary supplements. The IOM Report highlights the issues surrounding the safety of caffeine in foods and concludes that continued research is necessary to determine whether caffeinated foods and dietary supplements are safe, particularly for children and adolescents. The full text of the IOM Report on Caffeine in Foods and Supplements may be accessed here.

We first reported on FDA’s interest in examining the safety of caffeine in foods and dietary supplements in May 2013, when the FDA formally announced its intentions to investigate caffeine added in foods. As previously reported, FDA decided to investigate the safety of caffeine in foods as a response to the influx of these products on the market in recent years and due what the FDA has characterized as numerous health-related complaints made in conjunction with the use of caffeine-containing beverages and dietary supplement products.

Whether caffeine in foods and dietary supplements is determined to be safe can impact the viability of numerous products on the market. In particular, the FDA may take enforcement actions against any products that it considers to be unsafe to the public. For example, in 2010, the Agency took action against several caffeinated alcoholic beverages on the market due to health-related risks. Accordingly, whether caffeine is found to be unsafe in foods has a bearing on the FDA’s course of action and whether it may step up enforcement moving forward. If you have any questions about the FDA regulation of caffeine in foods or dietary supplements or need the assistance of a FDA regulatory attorney, please contact us at: contact@giannamore-law.com.FDA Attorney  150x150 FDA Issues Statement on IOM Report on Safety of Caffeine in Foods

Jan 16

FDA Issues Guidance on Distinguishing Liquid Dietary Supplements from Beverages

On January 16, 2014, the U.S. Food & Drug Administration (“FDA”) published a guidance document entitled “Distinguishing Liquid Dietary Supplements from Beverages” (“Guidance”). Found here, the Guidance is aimed at explaining to industry how dietary supplements and beverages differ.

Beverages are considered a type of conventional food, which differ from dietary supplements in both labeling and the ingredients that are permitted. For example, beverages differ from dietary supplements in that the labels of these products bear nutrition facts panels, as opposed to supplement facts panels, and the products are also distinguished by claims made in labeling. For example, the Guidance document notes that beverages are intended primarily to “to quench thirst or otherwise provide a source of fluids (e.g., water, soda), provide nutritive value (e.g., milk, orange juice), or provide taste and aroma (e.g., hot cocoa).” Guidance at 6. By contrast, dietary supplements are products that are intended to supplement the diet and promote health in various ways. Accordingly, the claims that may be made in the labeling of beverage products are somewhat more limited than those made for dietary supplements.

In addition to differences in labeling, including claims, beverages differ from dietary supplements by the ingredients that are permitted. Under federal law, dietary supplements must contain one or more dietary ingredients, which include vitamins, minerals, herbs and amino acids. 21 USC § 321(ff)(1). As explained in the Guidance, “to be lawful for use in a conventional food, [an] ingredient must be used in conformity with a food or color additive regulation prescribing the conditions of its use in food, be GRAS for its intended use in food, or qualify for one of the other exceptions to the food additive definition.” Guidance at 7. Accordingly, the ingredients permitted in foods are more limited than those that may be used in dietary supplements.

In sum, whether a product is properly marketed as a beverage or a dietary supplement will depend on a number of factors, including labeling, intended use, and ingredients, among other things. Thus, when developing a product to bring to market or importing a product into the United States, it is important to ensure that these factors are considered to ensure that the product is properly regulated. If you have any questions about the differences between beverages and dietary supplements or how you can successfully market products in compliance with the laws and regulations enforced by the FDA, please contact us at contact@giannamore-law.com.

FDA Attorney 150x150 FDA Issues Guidance on Distinguishing Liquid Dietary Supplements from Beverages

Jan 08

FDA Warns Consumers About Dietary Supplement Containing Synthetic Steroids

On December 23, 2013, the U.S. Food and Drug Administration (“FDA”) issued an announcement warning consumers about the serious health risks associated with using “Mass Destruction,” a product marketed as a dietary supplement for muscle growth. This product is manufactured for Blunt Force Nutrition in North Carolina and is sold in retail stores, gyms, and on the internet. The FDA alleges that despite being labeled as a dietary supplement, Mass Destruction contains synthetic anabolic steroids, which makes it an unapproved new drug in violation of the Federal Food, Drug, and Cosmetic Act (“FDCA”). The FDA’s announcement may be found here.

Under the FDCA, as amended by the Dietary Supplement Health and Education Act (DSHEA) of 1994, dietary supplements–defined as products taken by mouth that contain one or more “dietary ingredients” intended to supplement the diet–are regulated as a type of food and must comply with the particular requirements for the safety and labeling of dietary supplements. With the exception of new dietary ingredients, dietary supplements are unlike drugs in that they do not require FDA- approval prior to marketing. Instead, the manufacturer is responsible for ensuring that the product is safe and that any adverse events connected to the supplements are reported to the FDA. The FDA has authority to act once it receives reports of serious health problems associated with products for sale.

As highlighted by this case, the FDA has frequently targeted companies that market dietary supplements containing synthetic steroids or steroid-like ingredients because these compounds typically do not qualify as dietary ingredients as defined by Section 201(ff)(1) of the FDCA and have not been reviewed by the FDA for safety and effectiveness, causing them to be unapproved new drugs. Accordingly, it is illegal for dietary supplements to contain these steroids, which are linked to serious health problems such as liver failure.

In sum, if you have any questions about the FDA’s requirements for dietary supplements or about compliance with food and drug law generally, please contact us at: contact@giannamore-law.com.

 

FDA Attorney 150x150 FDA Warns Consumers About Dietary Supplement Containing Synthetic Steroids

Dec 19

FDA Seeks to Review Safety and Effectiveness of Antibacterial Soaps

On December 16, 2013, the U.S. Food & Drug Administration (FDA) issued a proposed rule, “Safety and Effectiveness of Consumer Antiseptics,” that would require manufacturers of over-the-counter (OTC) antibacterial soaps and body washes to provide the FDA with data demonstrating that the products are safe for long-term use and effective in preventing illness and infection. You can read the FDA’s announcement here.

The proposed rule is part of the FDA’s ongoing review of the safety and effectiveness of the active ingredients in antibacterial soaps and related products, which are not found in non-antibacterial, or plain, soap. Further, as noted above, these products are regulated as OTC drugs, etc., as opposed to soaps generally, which are typically regulated as cosmetics by the FDA. As far as the ingredients found in these antibacterial products, the FDA notes that new data suggests that long-term exposure to certain active ingredients—primarily triclosan and triclocarban–in antibacterial products poses health risks such as hormonal effects and resistance to antibiotics. Also, according to the FDA, there is no evidence that antibacterial soaps and hand washes are more effective at preventing illness and reducing infection than plain soap and water.

If finalized, the rule would require manufacturers to submit additional evidence that the active ingredients in antibacterial soap and other products are safe for repeated daily use and provide a clinical benefit as compared to non-antibacterial soap and water. Specifically, the risk must be balanced by the clinical benefit to establish that the OTC antibacterial active ingredients are generally recognized as safe and effective (GRASE) for their intended use. Otherwise, to continue marketing the products, manufacturers would need to remove the antibacterial active ingredients from the product and the antibacterial claims from the product’s labeling. Accordingly, if finalized, the rule would require both formulation and labeling changes for those companies marketing these products.

In sum, the proposed rule will be available for comment for 180 days, until June 16, 2014, with a concurrent one-year period for companies to submit new data and information. If you have any questions about this announcement, GRASE status, or compliance with any FDA regulations pertaining to cosmetics or OTC drugs and need a food and drug (FDA) lawyer, please contact us at:  contact@giannamore-law.com.FDA Attorney 150x150 FDA Seeks to Review Safety and Effectiveness of Antibacterial Soaps

Nov 20

U.S. Marshals Seize Dietary Supplements Containing DMAA from Georgia Company

On November 12, 2013, the U.S. Marshals, at the request of the U.S. Food and Drug Administration (FDA), seized dietary supplements manufactured and held by Hi-Tech Pharmaceutical, Inc., located in Georgia. According to the FDA, the dietary supplements are adulterated because they contain Dimethylamylamine (DMAA), a new dietary ingredient, in violation of the Federal Food, Drug, and Cosmetic Act (FDCA). DMAA is an amphetamine derivative that is considered unsafe under federal law because it is associated with serious health risks. You can read the FDA’s announcement here.

In October 2013, during an inspection at the Hi-Tech facility, FDA investigators found DMAA ingredients and eleven products containing DMAA or its chemical equivalent. Subsequently, on November 1, 2013, the FDA issued an administrative detention to temporarily hold the products until they were seized. Under section 304(h) of the FDCA, as amended by the Bioterrorism Act of 2002, the FDA is authorized to detain a food or dietary supplement if the agency believes that the product presents a threat of serious health consequences. Under federal law, the FDA is allowed to detain the products for a maximum of thirty (30) days until the agency decides whether to take further enforcement action, such as seizure.

Overall, the FDA’s action against Hi-Tech is part of the agency’s effort to remove DMAA from the market. In April, the FDA sent warning letters to several companies advising them that DMAA-containing products are illegal because DMAA has not been proven safe for consumers. In addition to DMAA issues, this situation highlights the importance of responding adequately to warning letters because failure to do so can subject a company to FDA enforcement actions such as the seizure of products, criminal prosecution, and/or an injunction. More detailed information about responding to warning letters can be found here.

If you have any questions about FDA regulation of dietary supplements, DMAA or FDA warning letters or if you need assistance from a food and drug (FDA) lawyer, please contact us at: contact@giannamore-law.com.

FDA Attorney 150x150 U.S. Marshals Seize Dietary Supplements Containing DMAA from Georgia Company

Nov 15

FDA Acts to Ban Trans Fat in Foods

On November 7, 2013, the U.S. Food and Drug Administration (“FDA”) published an announcement, entitled “Tentative Determination Regarding Partially Hydrogenated Oils,” announcing its preliminary determination that Partially Hydrogenated Oils (“PHOs”), which are the primary source of trans fatty acids (trans fat) in processed foods, are not generally recognized as safe (GRAS) for any use in food. The FDA’s determination is based on evidence that the consumption of PHOs, which are commonly added to food to increase shelf life and flavor, are associated with serious health risks. Accordingly, the FDA’s action signals the first steps in a move to ban trans fat in foods. You can read the Federal Register notice here.

If the determination is finalized, PHOs, and in turn trans fat, would be considered a food additive subject to pre-market approval by the FDA. Specifically, pursuant to Sections 201(s) and 409 of the U.S. Food, Drug, and Cosmetic Act (“FDCA”) any substance that is intentionally added to food is a food additive that must be reviewed and approved by the FDA prior to its being added as an ingredient, unless the substance is GRAS. To be GRAS, there must be either a consensus among qualified experts, based on scientific evidence, that the substance is safe under conditions of its intended use or a common use of the substance in food prior to 1958. Pursuant to FDA regulations, the agency may determine that a substance is not GRAS and is thereby a food additive when it believes there is no longer a consensus about its safety.

Although PHOs have been commonly used as an ingredient in processed food since the 1950s and are considered GRAS by the food industry, the FDA has tentatively determined that PHOs should not have GRAS status because trans fat, an integral component of PHOs, is associated with serious health risks such as heart disease. According to the FDA, the common use of a food prior to 1958 is insufficient to support continued GRAS status if there is no longer a scientific consensus that the substance is safe for its intended use in food. Thus, common use of a substance in food prior to 1958, alone, is not enough for a substance to maintain GRAS status.

In conclusion, the notice is available for public comment for 60 days. The FDA has especially requested comments regarding the impact of the removal of PHOs on small businesses and the time it would take businesses to phase out the use of PHOs. For example, the removal of PHOs, and accompanying trans fat, may impact businesses by requiring companies to undertake product reformulations and relabel affected products in order to comply with the FDA’s determination, if finalized. If the FDA does make a final determination, the next step will be a notice in the Federal Register.

If you have any questions about this notice or compliance with food additive regulations or regulatory compliance generally, please contact us at contact@giannamore-law.com.

FDA Attorney 150x150 FDA Acts to Ban Trans Fat in Foods

Nov 12

J&J Company Pleads Guilty to Misbranding for Off-Label Marketing

On November 4, 2013, the U.S. Food and Drug Administration (FDA) and the U.S. Department of Justice announced that Janssen Pharmaceuticals, Inc. (JPI), a Johnson & Johnson company, pled guilty to misbranding the drug Risperdal (risperidone) in violation of the Federal Food, Drug, and Cosmetic Act (FDCA), arising from its off-label marketing of the drug. Under the plea agreement, the Company is required to pay a $400 million criminal fine. It will also be required to pay civil penalties under a separate settlement concerning Risperdal. The cases resulting in these settlements originated from qui tam, or “whitstleblower,” lawsuits filed under the federal False Claims Act. You can read the announcement on the FDA’s website.

Risperdal is an atypical anti-psychotic drug that was approved by the FDA for the treatment of schizophrenia in 2002 and the treatment of acute mania and mixed episodes associated with Bipolar I disorder in 2003. Pursuant to the FDCA, physicians are allowed to prescribe drugs to patients for unapproved uses within the practice of medicine but the marketing or promoting a FDA-approved drug for indications other than those that are contained on the drug’s label, commonly known as off-label marketing, renders the drug misbranded in violation of federal law. In this case, the FDA alleged that, beginning in March 2002, JPI promoted Risperdal to health care providers for the treatment of agitation in elderly dementia patients and certain behavioral challenges in children, two uses for which Risperdal had not been proven safe and effective, and thereby misbranded the drug. Risperdal was not approved for any use in children until 2006 and has never been approved to treat dementia in the elderly.

In sum, in addition to its settlement agreements, JPI is subject to a corporate integrity agreement entered into with the Department of Health and Human Services as a way to prevent future fraud and abuse. If you have any questions about compliance with the FDA provisions involved in these recent settlements or other FDA laws and regulations pertaining to off-label marketing, please contact us at: contact@giannamore-law.com.FDA Attorney 150x150 J&J Company Pleads Guilty to Misbranding for Off Label Marketing

Oct 28

FDA Seeks Permanent Injunction against Oregon Dietary Supplement Company

On October 21, 2013, the U.S. Food and Drug Administration (“FDA”) announced that it is seeking a permanent injunction against James G. Cole, a dietary supplement manufacturer based in Oregon, along with the company’s president, James G. Cole, and general manager, Julie D. Graves. The complaint was filed on the FDA’s behalf by the U.S Department of Justice. If granted, the permanent injunction would prohibit James G. Cole from marketing and distributing its products until it complies with Current Good Manufacturing Practice (“cGMP”) requirements for dietary supplements and removes all unapproved drug claims from its product labels and websites. You can read the announcement here.

The FDA is targeting James G. Cole for unlawfully marketing its dietary supplements as unapproved drugs in violation of the Federal Food, Drug, and Cosmetic Act (“FDCA”). More specifically, the FDA is alleging that the company makes “drug claims” on its website and product labeling by promoting its dietary supplements as treatments for serious medical conditions such as cancer, heart disease, and arthritis. Under the FDCA, any product sold as a dietary supplement and promoted as a treatment, diagnosis, cure, or prevention of a disease or condition loses its status as a dietary supplement and is considered a new drug. Unlike drugs, the labeling of dietary supplements are only allowed to contain health claims, structure/function claims, and nutrient content claims, as permitted by FDA regulations.

Additionally, the FDA alleges that at the James G. Cole facility, the agency found serious violations of the cGMP requirements for dietary supplements, which are published in Title 21 of the Code of Federal Regulations, Part 111. These requirements mandate that any person who manufactures, packages, labels, or holds a dietary supplement establish and follow current good manufacturing practice to ensure the quality of the dietary supplement and to ensure that the dietary supplement is packaged and labeled in compliance with the master manufacturing record. FDA argues that in violation of these regulations, James G. Cole did not establish an “identity specification” for each component in its dietary supplements and did not conduct at least one appropriate test to verify the identity of a dietary ingredient.

In sum, failure to comply with the laws and regulations pertaining to dietary supplement labeling and manufacturing operations can have serious consequences, including the halting of distribution altogether. Accordingly, it is important to establish compliance with the laws and regulations enforced by the FDA in order to avoid costly delays and stoppages. If you have any questions about compliance with dietary supplement regulations or other laws enforced by the FDA, please contact us at: contact@giannamore-law.com.

FDA Attorney 150x150 FDA Seeks Permanent Injunction against Oregon Dietary Supplement Company

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