New alliance will crack down on adulterated products touting dietary supplement claims
WASHINGTON — The dietary supplement industry’s leading trade associations on Wednesday joined forces with the Food and Drug Administration to support heightened efforts to address 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.
The FDA’s concerns focus on three categories of products particularly susceptible to spiking with undisclosed ingredients: weight loss, sexual enhancement and body building, all 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 committed to remain vigilant in their monitoring of the full supply chain and selection of ingredient suppliers; review manufacturing and quality assurance activities to ensure the legality, quality and safety of products, particularly those most vulnerable to potential adulteration; and make use of the new tools the FDA has made available to the industry to report any suspected tainted supplement ingredients or finished products.
The industry coalition included representatives from the American Herbal Products Association, the Consumer Healthcare Products Association, the Council for Responsible Nutrition, the Natural Products Association and the United Natural Products Alliance. The industry trade associations pledged their support to help the 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 the 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.
Furthermore, this industry coalition supported the agency’s efforts to alert consumers to areas of potential concern and to provide tips for selection of supplements, such as buying from legitimate companies and sources with strong reputations — and not to 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. “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,” the coalition stated.
The efforts were praised by the National Alliance for Hispanic Health, the nation’s leading Hispanic health advocacy group, said, "[the] action by the FDA will help clean up the industry, return consumer confidence about the safety of the products available and save lives."
J&J’s Alex Gorsky, Sheri McCoy named vice chairmen
NEW BRUNSWICK, N.J. — Johnson & Johnson on Wednesday announced that Alex Gorsky, currently worldwide chairman of medical devices and diagnostics, and Sheri McCoy, currently worldwide chairman of pharmaceuticals, have been appointed vice chairmen of the executive committee, joining William Weldon, J&J chairman and CEO, in an expanded Office of the Chairman.
Both appointments are effective Jan. 3.
“The changes are an appropriate step in furthering our long-term succession plans, and assuring talented, experienced leaders at all levels of the organization,” Weldon stated.
Gorsky, 50, will assume expanded responsibilities that include the medical device and diagnostics group, global supply chain, government affairs and policy, and the Johnson & Johnson Development Corp. McCoy, 52, will assume expanded responsibilities that include the pharmaceuticals group, consumer group, the corporate office of science and technology, and corporate affairs.
Other executive announcements include Jesse Wu, currently company group chairman of global markets organization in the consumer group, was named worldwide chairman of consumer and will report to McCoy. Joaquin Duato, formerly pharmaceuticals company group chairman of the Americas group, was named worldwide chairman of pharmaceuticals with responsibility for commercial businesses and operations. And Paul Stoffels, currently global head of pharmaceuticals research and development, was named worldwide chairman of pharmaceuticals with responsibility for research and development, business development and strategic development. Both Duato and Stoffels will report to McCoy.
Peter Fasolo, worldwide VP human resources, will join the executive committee and continue to focus on talent development and succession planning at all levels of the corporation.
Little Colds Honey Elixir hits market
IRVINGTON, N.Y. — Prestige Brands last month announced the introduction of Little Colds Honey Elixir, a nonmedicated treatment for cough and sore throat, as the newest addition to the Little Remedies line.
“The incidence of cough is already higher this year than last [year] among children [under 5 years of age], according to the Fan Flu data reports in November,” stated Jean Boyko, SVP science and technology at Prestige.
The Little Remedies line now offers four products for the treatment of cough and cold symptoms in children ages 4 years and younger. In addition to the new honey elixir, these include Little Colds Safety Pops for sore throat irritation, Little Noses Saline for nasal congestion and Little Fevers for fever and pain relief.
Little Colds Honey Elixir provides the benefits of natural honey to children between the ages of 1 year and 4 years, the company stated.
A teaspoon is recommended every two to four hours using the measuring cup provided with the product. Little Colds Honey Elixir also may be used by children older than 4 years in a dosage of 2 tsp.