FDA publishes report on cost of DSHEA implementation

The US Food and Drug Administration (FDA) has responded to a request from the US Congress and drawn up a detailed analysis of the likely cost of implementing the Dietary Supplement Strategy 10-Year Plan, drawn up in January 2000 to ensure the rapid implementation of the DSHEA.

The Dietary Supplement Health and Education Act (DSHEA) of 1994 was designed to regulate the dietary supplement industry and ensure the safety of products in terms of composition and labelling.

The DSHEA covers the composition, production, labeling and marketing of dietary supplements containing at least one of the following ingredients: a vitamin or a mineral; a herb or other botanical; an amino acid; a dietary substance for use by humans to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent extract or a combination of the preceding ingredients.

The DSHEA does not cover dietary ingredients which were already on the market, as these were considered to be generally safe, and supplements containing these ingredients are permitted to be marketed without advance notification.

The FDA is responsible for taking action against any dietary supplement product after it reaches the market if it is found to presents an unreasonable or significant risk of illness or injury or has labelling that is false or misleading. The Federal Trade Commission regulates dietary supplement advertising.

The FDA said the challenge was to strike the right balance between preserving consumers' access to both products and information and ensuring the safety and proper labelling of all of these products, and began a year-long project to draw up a framework of how best to implement the regulations.

The result of this was the action plan which the FDA said was based on the "twin pillars" of law and science. It is divided into six sections: safety, labelling, boundaries (i.e. the definition of what is covered by the DSHEA), enforcement, science base and outreach.

The FDA said the plan was designed to be implemented in stages, reaching full operating level within five years. The FDA estimated that the initial investment to implement the plan would be between $20 million and $40 million by year three, followed by an additional investment from $30 million to $55 million for year four and a final investment from $40 million to $65 million for year five.

A full version of the FDA's costing analysis for the action plan can be found on the Center for Food Safety and Applied Nutrition website​.