Chemins

Last updated
Chemins
IndustryDietary Supplements
Founded1974;50 years ago (1974)
FounderJames Cameron
Defunct2007 (2007)
FateAcquired by Nexgen Pharma
Headquarters
Colorado Springs, Colorado
,

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]

Contents

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for the multi-level marketing companies Metabolife (i.e., Metabolife 356, an ephedra-based supplement that was withdrawn following numerous adverse event reports) [4] [5] and LifeVantage (i.e., Protandim, an herbal-based supplement).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 ephedra-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. [15] [16]

Related Research Articles

<span class="mw-page-title-main">Food and Drug Administration</span> United States federal agency

The United States Food and Drug Administration is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.

<span class="mw-page-title-main">Dietary supplement</span> Product providing additional nutrients

A dietary supplement is a manufactured product intended to supplement a person's diet by taking a pill, capsule, tablet, powder, or liquid. A supplement can provide nutrients either extracted from food sources, or that are synthetic. The classes of nutrient compounds in supplements include vitamins, minerals, fiber, fatty acids, and amino acids. Dietary supplements can also contain substances that have not been confirmed as being essential to life, and so are not nutrients per se, but are marketed as having a beneficial biological effect, such as plant pigments or polyphenols. Animals can also be a source of supplement ingredients, such as collagen from chickens or fish for example. These are also sold individually and in combination, and may be combined with nutrient ingredients. The European Commission has also established harmonized rules to help insure that food supplements are safe and appropriately labeled.

<span class="mw-page-title-main">Ephedrine</span> Medication and stimulant

Ephedrine is a central nervous system (CNS) stimulant that is often used to prevent low blood pressure during anesthesia. It has also been used for asthma, narcolepsy, and obesity but is not the preferred treatment. It is of unclear benefit in nasal congestion. It can be taken by mouth or by injection into a muscle, vein, or just under the skin. Onset with intravenous use is fast, while injection into a muscle can take 20 minutes, and by mouth can take an hour for effect. When given by injection it lasts about an hour and when taken by mouth it can last up to four hours.

<span class="mw-page-title-main">Ephedra (medicine)</span> Medicinal preparation from the plant Ephedra sinica

Ephedra is a medicinal preparation from the plant Ephedra sinica. Several additional species belonging to the genus Ephedra have traditionally been used for a variety of medicinal purposes, and are a possible candidate for the soma plant of Indo-Iranian religion. It has been used in traditional Chinese medicine, in which it is referred to as Ma Huang, for more than 2,000 years. Native Americans and Mormon pioneers drank a tea brewed from other Ephedra species, called "Mormon tea" and "Indian tea".

Nutraceutical is a marketing term used to imply a pharmaceutical effect from a compound or food product that has not been scientifically confirmed or approved to have clinical benefits. In the United States, nutraceuticals are unregulated, existing in the same category as dietary supplements and food additives by the Food and Drug Administration (FDA), under the authority of the Federal Food, Drug, and Cosmetic Act.

TrimSpa was a dietary supplement designed for weight loss, marketed by the company Goen Technologies and headed by Alexander Szynalski. The ephedra-based supplement was marketed by TrimSpa to help "stave off hunger", until ephedra was banned from the United States. TrimSpa's parent company, Goen Technologies, filed for bankruptcy protection in May 2008.

The ECA stack is a drug combination used in weight loss and as a stimulant. ECA is an initialism for ephedrine, caffeine, and aspirin, with variants of it including the EC stack, which removes the aspirin for those who can not tolerate it. Dietary supplements based on or including elements of ECA were popular through the 1990s and early 2000s, but the marketing of ephedra- or ephedrine-containing stimulant combinations for weight loss and bodybuilding is now restricted or illegal in the United States and the Netherlands due to reports of heart attack, stroke, and death associated with these supplements.

Hydroxycut is a brand of dietary supplements that is marketed as a weight loss aid. Hydroxycut was originally developed and manufactured by MuscleTech Research and Development; MuscleTech was sold to Iovate Health Sciences in 2003–2004 and declared bankruptcy in 2005; Iovate continues to use MuscleTech as a brand to market Hydroxycut.

Chinese patent medicine are herbal medicines in Traditional Chinese medicine, modernized into a ready-to-use form such as tablets, oral solutions or dry suspensions, as opposed to herbs that require cooking.

The Center for Food Safety and Applied Nutrition is the branch of the United States Food and Drug Administration (FDA) that regulates food, dietary supplements, and cosmetics, as opposed to drugs, biologics, medical devices, and radiological products, which also fall under the purview of the FDA.

Dexatrim is an over-the-counter (OTC) dietary supplement meant to assist with weight loss. Dexatrim claims it "gives you the power to lose weight, curb binges, and keep you in control of your diet." Current Dexatrim products available are in capsule form and include Dexatrim Max Complex 7, Dexatrim Max Daytime Appetite Control, Dexatrim Natural Green Tea, and Dexatrim Natural Extra Energy. The major active ingredients found in current Dexatrim products include caffeine, green tea extract, Asian (Panax) ginseng root extract, and dehydroepiandrosterone (DHEA).

Metabolife International, Inc. was a multi-level marketing company based in San Diego, California which manufactured dietary supplements. Metabolife's best-selling product, an ephedra supplement called Metabolife 356, once generated hundreds of millions of dollars in annual sales. However, Metabolife 356 and other ephedra-containing supplements were linked to thousands of serious adverse events, including deaths, which caused the U.S. Food and Drug Administration (FDA) to ban the sale of ephedra-containing dietary supplements in 2004.

Protandim is a herbal dietary supplement marketed with unsupported claims that it can treat a number of medical conditions. The product is a patented mix of five herbal ingredients and sold by LifeVantage Corporation, a Utah-based multi-level marketing company. The manufacturers of Protandim claim it can prevent or cure a wide variety of medical conditions. In 2017, LifeVantage was issued a warning letter by the U.S. Food and Drug Administration (FDA) regarding illegal advertising claims on the company's websites suggesting that Protandim can help to cure various ailments, including cancer and diabetes.

<span class="mw-page-title-main">Methylhexanamine</span> Chemical compound

Methylhexanamine is an indirect sympathomimetic drug invented and developed by Eli Lilly and Company and marketed as an inhaled nasal decongestant from 1948 until it was voluntarily withdrawn from the market in the 1980s.

<span class="mw-page-title-main">Regulation of food and dietary supplements by the U.S. Food and Drug Administration</span> Governmental regulation of food quality

The regulation of food and dietary supplements by the U.S. Food and Drug Administration is a process governed by various statutes enacted by the United States Congress and interpreted by the U.S. Food and Drug Administration ("FDA"). Pursuant to the Federal Food, Drug, and Cosmetic Act and accompanying legislation, the FDA has authority to oversee the quality of substances sold as food in the United States, and to monitor claims made in the labeling about both the composition and the health benefits of foods.

<span class="mw-page-title-main">Swanson Health Products</span> American distributor of vitamins and supplements

Swanson Health Products (SHP) is a natural health catalog and Internet marketing company headquartered in Fargo, North Dakota. The company sells natural health and wellness products, including health foods, dietary supplements such as vitamins, minerals, herbs, as well as natural personal care products directly to consumers through mail-order catalogs and an e-commerce website.

<span class="mw-page-title-main">Dietary Supplement Health and Education Act of 1994</span> 1994 statute of United States Federal legislation

The Dietary Supplement Health and Education Act of 1994 ("DSHEA"), is a 1994 statute of United States Federal legislation which defines and regulates dietary supplements. Under the act, supplements are regulated by the FDA for Good Manufacturing Practices under 21 CFR Part 111. The act was intended to exempt the dietary and herbal supplement industry from most FDA drug regulations, allowing them to be sold and marketed without scientific backing for their health and medical claims.

The Council for Responsible Nutrition (CRN) is a Washington D.C.-based trade association and lobbying group representing ingredient suppliers and manufacturers in the dietary supplement industry. CRN's current president and CEO is Steve M. Mister.

Pre-workout is a generic term for a range of bodybuilding supplement products used by athletes and weightlifters to enhance athletic performance. Supplements are taken to increase endurance, energy, and focus during a workout. Pre-workout supplements contain a variety of ingredients such as caffeine and creatine, differing by capsule or powder products. The first pre-workout product entered the market in 1982, and since then the category has grown in use. Some pre-workout products contain ingredients linked to adverse effects. Although these products are not regulated, the Food and Drug Administration (FDA) warns consumers to be cautious when consuming them.

<span class="mw-page-title-main">The Proxmire Amendment</span> US legislation related to dietary supplements

The Proxmire Amendments were a series of legislation that prohibited the Food and Drug Administration from monitoring and limiting the potency of vitamins and minerals found in dietary supplements. The Proxmire Amendment also made it so that food supplements could not be classified as drugs, making their sale possible without a prescription from a doctor. According to a study done, "dietary supplements fall into the following categories: vitamins, minerals, herbs or other botanicals, amino acids, animal-derived products, hormones and hormone analogues, enzymes, and concentrates, metabolites, constituents, or extracts of these." They can be used by anyone wishing to purchase them as much or as little as they desire. Dietary supplements can be used to increase productivity, treat illness, help mental health such as depression and anxiety, enhancing mental abilities, building muscle, or losing weight, among many other uses. William Proxmire, a Senator for Wisconsin, was instrumental in influencing the passing the Proxmire Amendment. The Proxmire Amendment is also known as The Rogers-Proxmire Amendment of 1976, and The Vitamins and Minerals Amendments. This amendment became section 411 of the Federal Food, Drug, and Cosmetic Act.

References

  1. 1 2 Gugliotta, Guy (July 23, 2000). "Ephedra Lawsuits Show Big Increase". The Washington Post . Retrieved 2012-08-22.[ dead link ]
  2. 1 2 "Protein Powder Consumers Allege Product Mislabeling in Class Action Settlement". PRNewswire. Retrieved 2014-09-28.[ dead link ]
  3. 1 2 "Campbell v. Chemins". Class Action Administration. Retrieved 2012-08-23.
  4. 1 2 Gonzalez, Steve (November 30, 2004). "Metabolife and Walgreen's hit up for $450k". The Madison / St. Clair Record . Archived from the original on 2013-10-15. Retrieved 2012-08-22.
  5. 1 2 Bortnick, Barry (April 22, 2000). "Diet drug maker faces wrongful death lawsuits -- maker of Metabolife 356 is targeted". The Gazette . Archived from the original on November 5, 2013. Retrieved 2012-08-23.
  6. 1 2 "LIFELINE THERAPEUTICS, INC., Form 10KSB/A, Filing Date Jan 26, 2006". secdatabase.com. Retrieved May 15, 2018.
  7. "Nexgen Pharma(TM), Inc. Announces Acquisition of Colorado Based Manufacturing Facility". BioSpace. Retrieved 2024-03-20.
  8. 1 2 Murdock, Keala (July 21, 2000). "Chemins to stay the course". The Gazette . Archived from the original on November 5, 2013. Retrieved 2012-08-22.
  9. 1 2 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. "Dietary-supplement maker indicted". Denver Post . Retrieved 2012-08-23.
  11. "United States of America v. Erenio Carranco Perez. No. 96-1216". United States Court of Appeals, Tenth Circuit. April 20, 1998. Archived from the original on May 17, 2010. Retrieved August 24, 2012.
  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" (PDF). United States House Committee on Oversight and Government Reform. October 2002. Archived from the original (PDF) on 2012-10-18. Retrieved 2012-08-23.
  14. "Lifevantage Corp, Form 10-K, Annual Report, Filing Date Sep 28, 2011" (PDF). secdatabase.com. Retrieved May 15, 2018.
  15. "Nexgen Pharma, Inc. Announces Acquisition of Colorado Based Manufacturing Facility". PRNewswire . August 16, 2007. Archived from the original on September 23, 2015. Retrieved 2012-08-23.
  16. "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. Archived from the original on October 15, 2013. Retrieved 2012-08-23.