Service(s) related to this article:  Dietary Supplements

Dietary supplement use is a growing sector with unique regulatory requirements. dicentra’s dietary supplement consulting can help get you on the road to success.

Dietary supplements are a products that are designed to supplement the diet of man and encompass a wide variety of products from multivitamins, herbal products, amino acids, protein powders to prenatal supplements. Moreover supplement use is a growing industry with the National Institute of Health (NIH) reporting that approximately 2/3 of Americans are purchasing these products supporting a $40 billion industry. While, multi-vitamin mineral (MVM) supplements are the most commonly purchased supplements, there continues to be growth in the market for specialty supplements as American consumers look for new and unique ways to support their health.

While it is a common misconception that dietary supplements are an unregulated industry, they are in fact under the Food and Drug Administrations (FDAs) purview and are specifically regulated under the Dietary Supplement Health and Education Act of 1994 (DSHEA). Moreover, FDA regulates dietary supplement ingredients and finished products as well as the manufacturers that produce them. Additionally the claims made on product labels are jointly regulated by the FDA and the Federal Trade Commission (FTC) that requires that claims made in labelling and advertising are supported by competent and reliable evidence and are neither false or misleading. In order to bring a new supplement to market there are many considerations that a company must review to determine if there product is compliant, this is where dietary supplement consulting can be an asset.

While the list below is by no means exhaustive, it is a good starting point for companies to refer for dietary supplement compliance.

• Are you in compliance with the cGMPs for dietary supplements?
• Has the manufacturing facility been registered with the FDA
• Does the product contain any New Dietary Ingredients (NDIs), which require notification to the FDA?
• Are ingredients Generally Recognized As Safe (GRAS), where applicable?
• Does the product contain food additives within the limits or commodity categories (where applicable)?
• Is the supplement label compliant?
• Are there any claims made on the product labelling or advertising? If yes, do you possess adequate and appropriate substantiation?
• Has the FDA been notified in writing of the structure function claims made on the supplement?

dicentra offers dietary supplement consulting services and can help you navigate the regulatory pathway to provide guidance on matters related to compliance for the supplement industry. Whether you require assistance with safety reviews and dossiers for supplement ingredients in the form of NDI Notifications or GRAS (FDA or self-affirmed) to Labelling services or GMP audits and training, dicentra is invested in your company’s success and can be your ideal strategic partner to help get you on the road to compliance.