Chemins

The Chemins Company is a dietary supplement manufacturer based in Colorado Springs, Colorado. The company, founded in 1974 by James Cameron, became embroiled in a series of criminal investigations in 1994 after a woman died and more than 100 other people became ill after taking one of the company’s products marketed under the brand name Nature's Nutrition Formula One.^[1] The adverse events were later linked to the product having been tainted with ephedrine. A three-year federal investigation, which revealed that the company had doctored records, misled FDA investigators, and purposely hindered inspections, led to Cameron being sentenced to 21 months in prison and him and the company being fined $4.7 million . The company also paid out $750,000 to settle a class action lawsuit alleging that the company's protein powder supplements contained approximately half the protein content and twice the carbohydrate content listed on the label.^[2][3]

Chemins was the manufacturer of dietary supplements for the multi-level marketing companies Metabolife (i.e., Metabolife 356, an ephedra-based supplement that was withdrawn following numerous adverse event reports)^[4][5] and LifeVantage (i.e., Protandim, an herbal-based supplement).^[6]

Chemins' assets were acquired by Nexgen Pharma in 2007.^[7]

Nature's Nutrition Formula One

Chemins initially came under regulatory scrutiny following a series of serious adverse event reports by consumers of Chemins' Nature's Nutrition Formula One. These reports led to an investigation of Chemins by the U.S. Food and Drug Administration (FDA) Office of Criminal Investigation, U.S. Department of Justice Office of Consumer Litigation, and the U.S. Attorney's Office in Denver, Colorado.

The investigation of Chemins was expanded subsequent to an incident on New Year’s Eve 1994, when police officers intercepted a 1,200-pound shipment of ephedrine (a methamphetamine precursor) aboard a truck that had crashed on an icy road near Colorado Springs while en route to an underground methamphetamine manufacturing lab.^{[8][9][10][11]} Container labels indicated to police that the chemicals originated from Chemins; however, when informed about the incident, Chemins president James Cameron denied that the company ever possessed or used ephedrine in its products.

Criminal proceedings were launched against Chemins and Cameron, and on July 7, 2000, following a three-year investigation, a Federal judge in Denver sentenced Cameron to 21 months in jail and fined him and Chemins 4.7 million dollars. In his plea agreement, Cameron admitted that he and his company had labeled Formula One as "all natural" but secretly spiked the product with synthetic pharmaceutical grade drugs, including ephedrine and caffeine and had done so with numerous other products, including one called Supercharge, without notifying consumers. He admitted that the product's labeling failed to disclose the use of the chemicals on the list of ingredients, and that he and his employees had misled FDA investigators and purposely hindered inspections of the company’s premises. Chemins actively conspired to hide from the FDA the fact that it possessed the undisclosed ingredients by, among other things, making a late night transfer of the ingredients to an employee's home during an FDA inspection and creating false manufacturing and inventory records that were shown to FDA inspectors. The company had denied using those ingredients after being confronted about it by the FDA.^{[1][8][9][12]}

Metabolife 356

Chemins produced Metabolife 356, an epehdra-based weight-loss product sold by the multilevel marketing company Metabolife.^[4][5] Chemins was responsible for the design, manufacture, labeling, packaging, advertising, marketing, and promotion of the product. Metabolife 356 and other ephedra-containing supplements were linked to thousands of serious adverse events, including deaths. These deaths caused the U.S. Food and Drug Administration (FDA) to ban the sale of ephedra-containing dietary supplements in 2004. After the withdrawal of Metabolife 356, a congressional investigation found that Metabolife had received thousands of reports of serious adverse events, many occurring in young and otherwise healthy people, and that the company had concealed the reports and acted with "indifference to the health of consumers."^[13]

Protein supplements

A class action lawsuit was launched against Chemins in the United States District Court of the District of Colorado on behalf of 10,000 claimants who had purchased the company's protein powder supplements marketed under various brand names. The suit alleged that the products contained approximately half the protein content and twice the carbohydrate content as listed on the label. The case was concluded when Chemins agreed to pay out a $750,000 settlement to reimburse consumers for the full cost of purchases of the products made between January 1, 1993 and January 31, 2002.^[2][3]

Protandim

In 2004, Chemins entered into a contract agreement to formulate and manufacture Protandim, an herbal-based antioxidant supplement sold by the Utah-based multi-level marketing company LifeVantage.^[6] In July 2008, LifeVantage announced that it was entering into an agreement with a different manufacturer (Cornerstone Research & Development) to produce Protandim.^[14]

Nexgen Pharma acquisition

Chemins' assets were acquired in 2007 by Irvine, California-based Nexgen Pharma, parent company of Vitamer Labs.^[7][15]

References

1. ↑ 1.0 1.1 Gugliotta, Guy (July 23, 2000). "Ephedra Lawsuits Show Big Increase". The Washington Post. Retrieved 2012-08-22. 
2. ↑ 2.0 2.1 "Protein Powder Consumers Allege Product Mislabeling in Class Action Settlement". PRNewswire. July 17. Retrieved 2014-09-28.  Check date values in: |date= (help)
3. ↑ 3.0 3.1 "Campbell v. Chemins". Class Action Administration. Retrieved 2012-08-23. 
4. ↑ 4.0 4.1 Gonzalez, Steve (November 30, 2004). "Metabolife and Walgreen's hit up for $450k". The Madison / St. Clair Record. Retrieved 2012-08-22. 
5. ↑ 5.0 5.1 Bortnick, Barry (April 22, 2000). "Diet drug maker faces wrongful death lawsuits -- maker of Metabolife 356 is targeted". The Gazette. Retrieved 2012-08-23. 
6. ↑ 6.0 6.1 "LifeVantage Corp - 10KSB/A (Filed 06 January 2006)". sec.edgar-online.com. Retrieved 2012-08-23. 
7. ↑ 7.0 7.1 "Nexgen Pharma, Inc. Announces Acquisition of Colorado Based Manufacturing Facility". PRNewswire. August 16, 2007. Retrieved 2012-08-23. 
8. ↑ 8.0 8.1 Murdock, Keala (July 21, 2000). "Chemins to stay the course". The Gazette. Retrieved 2012-08-22. 
9. ↑ 9.0 9.1 Lewis, Carol (January 1, 2001). "Dietary Supplement Maker Fined Twice What Company Profited (case involving the Food and Drug Administration". FDA Consumer. Retrieved 2012-08-22. 
10. ↑ McPhee, Mike (October 22). "Dietary-supplement maker indicted". Denver Post. Retrieved 2102-08-23.  Check date values in: |date=, |accessdate= (help)
11. ↑ "United States of America v. Erenio Carranco Perez. No. 96-1216.". United States Court of Appeals, Tenth Circuit. April 20, 1998. 
12. ↑ "Dietary Supplements and Their Use for Weight-loss Purposes (Statement of Joseph A. Levitt, Esq. Director Center for Food Safety and Applied Nutrition Food and Drug Administration Before the Subcommittee on Oversight of Government Management, Restructuring, and the District of Columbia Senate Committee on Governmental Affairs)". U.S. Food and Drug Administration. July 31, 2002. Retrieved 2012-08-22. 
13. ↑ "Adverse Event Reports from Metabolife". United States House Committee on Oversight and Government Reform. October 2002. Retrieved 2012-08-23. 
14. ↑ http://yahoo.brand.edgar-online.com/displayfilinginfo.aspx?FilingID=8164388-16511-132473&type=sect&dcn=0001193125-11-258536
15. ↑ "Irvine, Calif.-based Nexgen Pharma, parent company of Vitamer Labs, announced it acquired 250,000 square feet of manufacturing, laboratory and warehouse/ distribution space from The Chemins Co. in Colorado Springs, Colo". Natural Foods Merchandiser. October 1, 2007. Retrieved 2012-08-23.