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@sglawfl.com.

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@sglawfl.com.

Under the Federal Food, Drug and Cosmetic Act (“FFDCA”), manufacturers, packers and distributors of all dietary supplement products 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. Unlike the requirements pertaining to serious adverse event reporting for dietary supplements, federal law does not require manufacturers and distributors of conventional foods to provide the FDA with reports of serious adverse events. The FDA notes this distinction in its Statement, discussing how certain energy products are marketed as conventional foods and therefore their makers have not reported these adverse events to the Agency. Accordingly, the FDA says that it will continue to monitor issues surrounding energy drinks and supplements.

For more information about the FDA’s regulation energy drinks and dietary supplements generally, including how you may satisfy your adverse event reporting requirements, please feel free to contact us at contact@sglawfl.com.

As noted in the FDA’s announcement, Aubagio contains a Boxed Warning intended to alert prescribers and patients of certain risks, including liver problems and birth defects. Accordingly, prescribers are warned to refrain from prescribing Aubagio to patients who have existing liver problems. In addition, prescribers are required to verify that women of childbearing age are not pregnant prior to starting treatment with the drug and are using an effective birth control method during the pendency of treatment.

Boxed warnings are particularly serious warnings, typically indicating the potential for death or serious bodily injury that FDA regulations require to be used in certain situations. In particular, boxed warnings are commonly used three distinct scenarios. First, boxed warnings are used where a drug is known to have an adverse reaction that is so serious when considered in proportion to the drug’s potential benefit that the adverse reaction must be considered when assessing the risks and benefits of prescribing the drug. Second, a boxed warning is appropriate where a serious adverse event may be prevented or otherwise reduced in frequency by appropriate use of the drug, i.e., only being prescribed to certain types of patients. Finally, boxed warnings are used where the FDA approved the drug with certain restrictions to ensure safe use. Although these warnings may be used in other circumstances, there are considered the most common. More information about boxed warnings and other FDA warnings sections of labeling for prescription drugs may be found here.