Sabinsa Corporation today filed substantive comments with the FDA objecting to the Citizen Petition filed by Glaxo Smith Klein (GSK) requesting that weight loss claims be treated as disease claims.
GSK’s petition says that being overweight is a significant risk factor for certain diseases and therefore products purported to aid weight loss should be treated as drugs. The petition further claims that there is no credible scientific evidence to back up claims on any dietary supplement products.
“GSK appears to be using this petition in an attempt gain a monopoly in the OTC weight loss category,” stated industry regulatory attorney Marc Ullman, who drafted Sabinsa’s comments. “Consumers have spoken with their rejection of Alli and its side effects. It is unacceptable for GSK to use the FDA to try to knock any competition out of the market and deny consumers a choice of products.”
The industry’s trade associations have filed comments as have many health food store owners and consumers. Sabinsa’s petition, written by noted Ullman of Ullman Shapiro Ullman, is particularly relevant because it contains information based upon clinical studies on the company’s ForsLean® product indicating that the product does indeed aid in weight loss.
Sabinsa’s comments argue that GSK’s petition is simply an attempt by that company to gain a monopoly in the OTC weight loss category. GSK’s OTC product, Alli®, has met with disappointing sales, likely because the approved labeling warns of unsavory side effects including gas with oily spotting, hard to control and frequent stools, and further advises consumers that “it is probably as smart idea to wear dark pants, and bring a change of clothing with you to work” while using Alli, and to move rapidly to a bathroom in the event of a gas attack.
Sabinsa’s comments also reference the clinical studies of ForsLean as “an example of a well-researched botanical compound with demonstrated safety and efficacy in increasing lean body mass and managing weight.”
“Sabinsa has invested heavily in science to back its products, including ForsLean, since the company was founded 20 years ago,” said company CEO Jeff Lind. “Just as we adamantly defend our intellectual property, we strongly object to the assertion that there is no science behind any dietary supplements in the weight loss category.”
Sabinsa Corporation, founded in 1988, is a manufacturer and supplier of herbal extracts, cosmeceuticals, minerals and specialty fine chemicals.
Sabinsa's mission is to provide alternative and complementary natural products for human nutrition and well-being. Over the past 20 years, Sabinsa has brought to market more than 100 standardized botanical extracts and privately funded several clinical studies in conjunction with prestigious institutions in support of these products. With more than 80 scientists working full time conducting ongoing research both in India and the United States, Sabinsa continues to develop and patent phytonutrients for the world market. Most of our products intended for human consumption are certified Kosher, with some certified Halal.
For more information stop by the Sabinsa booth # 21051 at SupplySide West or visit www.forslean.com.