Seasilver

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Seasilver is the trademarked name of a commercial dietary supplement [1] produced and sold by the companies Seasilver USA, Inc. and Americaloe, Inc. [2]

Contents

The product was promoted with the false claim that it could "cure 650 diseases", resulting in the prosecution and fining of the companies' owners. [3]

Corporate history

Seasilver USA, Inc. was founded in 1992, [4] and ceased operating at the end of 2006. [5] Americaloe, Inc. was founded in Nevada in 1997. [6]

Law suit

In 2002 the US Food and Drug Administration sent a warning letter to the product's promoters for making unsubstantied health claims. [2] [7] On June 12, 2003, the FDA and FTC lodged a complaint that the two companies and their owners, Jason and Bela Berkes, had misled their customers with claims that Seasilver cured 650 diseases, including AIDS and some types of cancer. [5]

In 2003 US$5.6 million worth of product was seized by the FDA [1] and on March 4, 2004, the companies and their owners agreed to pay $3 million in six months as redress to their customers, to destroy the stocks of product, and to avoid making misleading statements to settle the FTC's complaint. They could still sell Seasilver, as long as any claims were supported by sufficient proof. If they did not pay the $3 million, they would have to pay the full $120 million judgement. [5] [3] The FTC found that the claims that the products were "clinically proven to treat or cure 650 diseases, including cancer and AIDS, and cause rapid, substantial and permanent weight loss without dieting" were false and could not be substantiated. [8] This was upheld by a federal judge in June 2006; the company was required to pay a penalty of $120 million because they had paid less than one third of the required $3 million to refund customers. [5] [8] Following non-payment and a failed appeal, the full fine of US$120 million was re-affirmed by a ruling of the Ninth Circuit Court of Appeals on April 10, 2008. [3] [8]

Product

The Seasilver product includes a variety of ingredients including the herb pau d'arco, cranberry and aloe. [7] It was a liquid supplement which was sold through a network marketing arrangement. [5] It was priced at $39.95 for a 32-oz bottle. [9] Before the legal action, Seasilver USA publicly stated that they made annual profits of $180 million from Seasilver. [10]

Health claims

In their initial complaint letter of 3 April 2002, the FDA identified the following disease claims which were made for Seasilver: [2]

Health effect

According to the Memorial Sloan-Kettering Cancer Center, "no studies have shown the efficacy of this costly product", [1] and Quackwatch say there is "no logical reason to use the product". [7] FDA Commissioner Mark McClellan described it as "intolerable health fraud ... that preys on consumers and patients by selling worthless dietary supplements as cures for serious and chronic diseases and conditions." [10]

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References

  1. 1 2 3 "Seasilver". Memorial Sloan-Kettering Cancer Center. 29 September 2012. Retrieved 31 August 2013.
  2. 1 2 3 "Inspections, Compliance, Enforcement, and Criminal Investigations – Warning Letter". Food and Drug Administration. 3 April 2002. Archived from the original on March 2, 2012. Retrieved 31 August 2013.
  3. 1 2 3 "Court orders Seasilver defendants to pay $120 million". Nutraceuticals World. 11 (6): 14. 2008.
  4. ↑ Rattle, Barbara (December 9, 2002). "California dietary supplements makers picks SLC as distribution center site". Enterprise. Salt Lake City, Utah. 32 (24): 2. Ten-year-old Seasilver...
  5. 1 2 3 4 5 Wright, Patrick (January 4, 2007). "Carlsbad-based Seasilver USA shuts down". North County Times. Escondido, CA. Retrieved 24 March 2022.
  6. ↑ Nevada Business Entity Information search for Entity Number=C26868-1997
  7. 1 2 3 Stephen Barrett, M.D. (August 2004). "Misleading Claims for Seasilver™". Quackwatch . Retrieved 31 August 2013.
  8. 1 2 3 "Seasilver sunk". Food Chemical News. Vol. 50, no. 9. April 21, 2008. Retrieved 24 March 2022.
  9. ↑ "Feds seize Seasilver offices". San Diego Business Journal. Vol. 24, no. 25. June 23, 2003. Retrieved 24 March 2022.
  10. 1 2 "FTC crackdown on rogue supplements in the USA gathers pace". Nutraceuticals International. July 2003. Retrieved 24 March 2022.
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