December 21, 2010 — The dietary supplement industry’s leading trade associations recently joined forces with FDA to support heightened efforts to address significant public health problems posed by products that are illegally marketed as dietary supplements but contain the same active ingredients as FDA-approved drugs or other ingredients that do not qualify as dietary ingredients.
Representatives from the American Herbal Products Association (AHPA), the Consumer Healthcare Products Association (CHPA), the Council for Responsible Nutrition (CRN), the Natural Products Association (NPA), and the United Natural Products Alliance (UNPA) joined FDA’s Principal Deputy Commissioner Joshua M. Sharfstein, MD, at a press teleconference where he announced steps the agency is taking to address this serious issue.
The industry trade associations pledged their support to help FDA rid the market of illegal products that both pose a danger to consumers and tarnish the reputation of the legitimate supplement industry.
The industry coalition also endorsed FDA’s actions to use its regulatory muscle to hold accountable those who violate the law and jeopardize the public health, using tough criminal sanctions when appropriate. In addition, by being transparent and engaging in ongoing dialogue with the supplement industry, the agency is acknowledging its understanding of the vital role that the associations can play in helping to ensure that consumers have access to safe, high quality products.
FDA’s concerns focus on three categories of products particularly susceptible to spiking with undisclosed ingredients: weight loss, sexual enhancement and body building, categories in which consumers may be looking for immediate or dramatic results. In a letter to the industry asking for support to address this problem, the agency signaled its acknowledgment that there are legitimate dietary supplement products in these three categories, noting that adulterated products “… undermine confidence in legitimately marketed dietary supplements in these and other categories.”
Agreeing that this issue is a high concern, the industry trade associations each are reminding their own member companies — and the entire supplement industry — of the responsibility to remain vigilant in their monitoring of the full supply chain and selection of ingredient suppliers; to review manufacturing and quality assurance activities to ensure the legality, quality, and safety of products, particularly those most vulnerable to potential adulteration; and to make use of the new tools FDA has made available to industry to report any suspected tainted supplement ingredients or finished products.
Further, this industry coalition supports the agency’s efforts to alert consumers to areas of potential concern and provide tips for selection of supplements. Regardless of what laws are in place, criminals will try to find ways to break those laws; consequently, consumers also play an important role in protecting their health and should remember to buy from legitimate companies and sources with strong reputations; and to not purchase products with claims that sound too good to be true or suggest drug-like effects when they are marketed as supplements.
Consumers also should be wary of products that boast they are of limited availability, only available for a short time, or are “barely legal,” as these claims may indicate there already may be legitimate concerns about their safety.
This initiative should serve as a strong warning to criminals that the government is serious about enforcing the law — and FDA’s actions today will go a long way toward reminding individuals and companies looking to make money without regard for consumer safety that it means business.
Those who purposefully spike products are not legitimate dietary supplement companies, and the supplement industry is actively committed to being a part of this problem’s solution.
Source: American Herbal Products Association, www.ahpa.org
