FDA and industry work together to further supplement legislation
three major regulatory initiatives by the FDA to further DSHEA ten
years after the legislation was first implemented.
The three initiatives, including a regulatory strategy, an open public meeting and a draft guidance document for the industry, will refine the direction the agency is taking to regulate dietary supplements, according to FDA acting commissioner Lester Crawford.
"We now have a clear roadmap to share with the dietary supplement industry, while at the same time giving consumers a higher level of assurance about the safety of dietary supplement products and the reliability of their labeling," said Crawford.
Ever since the ephedra affair last year, the FDA has said it intends to improve the way dietary supplements are regulated to protect consumers against unsafe products and prevent manufacturers making false or misleading claims.
The regulatory strategy, said the FDA, will lead to greater collaboration between it and other bodies - such as the National Institutes of Health Office of Dietary Supplements and National Center for Complementary and Alternative Medicine, the National Toxicology Program in the Department of Health and Human Services and the University of Mississippi's National Center for Natural Products Research - in the making of decisions concerning supplements.
The body also announced that it will put into place an improved process to monitor safety concerns about dietary ingredients and supplements. This process will begin with what the FDA is calling a "signal detection", or, in other words, the identification of a concern.
When the quality or quantity of these signals indicates that there may be a public health problem - for example a rush of reports in the media about the potential dangers of a certain supplement - the FDA may then seek input from an independent third party review before reacting.
The body noted that any action it takes will be based on the scientific evidence available.
The FDA had already announced last month that it will hold a public meeting on 15 November to give industry and consumers the chance to discuss the government body's premarket notification program for new dietary ingredients (NDIs).
The third initiative is the FDA's request for comments on a draft guidance document on the amount, type and quality of evidence a manufacturer should have to substantiate a structure claim.
"Providing a standard for substantiation may help to preserve consumer confidence in these products," said the FDA in a statement.
The body is keen to highlight the action it has taken, noting that on 22 October, for example, it sent eight warning letters to dietary supplement distributors for making unsubstantiated claims for products promoted for weight loss over the Internet.
"The FDA will continue to protect consumers by pursuing products that violate the law," said Crawford.
The supplement industry is generally in agreement that companies producing unsafe products or indulging in false advertising need to be brought to task to secure the future of the industry.
Kiran Krishnan from Amano Enzyme USA - that manufacturers the enzyme Nattokinase - last week voiced his concerns to NutraIngredientsUSA that other natto products on the market are not up to standard and could ruin the reputation of the supplement, particularly in the post-ephedra climate where the FDA is acting much quicker to remove products if there is any doubt about their safety and efficacy.
California based supplements manufacturer Natrol welcomed the FDA's stance. "Natrol has stressed quality and safety above commercialization," said Elliott Balbert, the company CEO. "I'm hopeful that the FDA's new strategies will be the catalyst for all companies in the industry to produce safe, effective and accurately labeled products that deserve the trust of consumers that many of us have worked tirelessly to earn."
Michael McGuffin, president of the American Herbal Products Association, took a similar view, adding that he urged everyone in the supplement business to read the newly published documents.
The documents are available on the FDA's website, where anybody wishing to ake their voice heard can comment on either the regulatory strategy and/or the topics to be discussed at the public meeting on 15 November.
