On December 12, during a speech at the Food and Drug Law Institute (FDLI) Enforcement, Litigation, and Compliance Conference, FDA Commissioner Scott Gottlieb M.D. announced the formation of the FDA Dietary Supplement Working Group. Dr. Gottlieb indicated the Working Group was created “to take a hard look at what more the FDA can be doing within our existing authorities, including re-examining our own internal operating structure and procedures – and what new authorities might make sense. We have some specific, new policy measures that we plan to pursue when it comes to modernizing our overall approach to dietary supplements.”
Dr. Gottlieb stated, “(s)ome products marketed as dietary supplements contain dangerous and illegal ingredients, often without identifying them to consumers. Some contain lawful ingredients, but their manufacturing processes fall far short of GMPs that are needed to assure a quality product. And others make illegal and unproven claims about their ability to treat serious diseases. We take seriously our obligation to protect consumers from all of these dangerous products.”
Several industry groups issued statements reacting to the speech. Some agreed with the request for increased scrutiny, while others asserted the regulations are already in place and what is required is to execute proper and diligent enforcement.
The FDA has made several efforts in the past 25 years to develop a consistent and coherent framework for regulating the dietary supplement industry and protecting consumers from unsafe products.
The first foray into dedicated dietary supplement regulation in the US came in 1994 when Congress passed the Dietary Supplement Health and Education Act (DSHEA). This law provided for the first time a working definition of a dietary supplement. Defined as, a food intended to supplement the diet that contains one or more of the following dietary ingredients: “a vitamin, a mineral, an herb or botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract, or combination of any of these ingredients.”
DSHEA required that to be classified a dietary supplement, a product must be intended for ingestion, not be labeled as a conventional food or as a sole item of a meal or diet and be clearly labeled as a dietary supplement.
The statute called for the Secretary of Health and Human Services to prescribe Good Manufacturing Practices (GMPs) for dietary supplements, modeled after cGMPs for foods.
In June 2007, the FDA released the final rule for dietary supplement cGMPs to, “require that proper controls are in place for dietary supplements so that they are processed in a consistent manner and meet quality standards.”
The GMPs included provisions for:
- the design and construction of physical plants that facilitate maintenance
- proper manufacturing operations
- quality control procedures
- testing final product or incoming and in-process materials
- handling consumer complaints
- maintaining records
Opinions vary on whether implementation of dietary supplement GMPs has increased enforcement and oversight, and if so, has it been enough.
Dietary supplement GMPs provide a framework specific to supplement quality, recognizing that often these product types are hybrids between food products and pharmaceuticals, and therefore require regulations acknowledging this distinction.
The Dietary Supplement Working Group promises to add another chapter to the story of supplement regulation in the United States. Industry stakeholders, and support companies should stay tuned and work together to assure compliance with new statutes and directives dedicated to providing safe products for consumers.
Dr. Gottlieb’s announcement here