Leiner First to Announce Compliance With FDA's Proposed Dietary Supplement Quality Standards

CARSON, Calif., March 18 -- Based on a history of setting the industry standard for quality manufacturing, Leiner Health Products announced today its full compliance with the newly published cGMPs for its dietary supplements. Leiner applauds the recent FDA announcement on proposed new manufacturing guidelines for the industry to ensure that consumers receive uniform, accurately labeled and unadulterated dietary supplements.

"Our company has always believed in providing the highest quality products to consumers exclusively through our retail partners," said Bob Kaminski, CEO of Leiner. "We are proud to be at the forefront of our industry to deliver against these newly issued standards."

"For more than a decade, Leiner has been producing dietary supplements under the highest drug cGMPs, which exceed the current proposed FDA supplement standards," said Patrick Dunn, senior vice president of Quality/Regulatory Affairs at Leiner.

Leiner has been a leader in quality innovation:

-- In May 1994, Leiner became the first manufacturer to formulate, test
and label its products as complying with the USP standards.
-- America's leading retailers quickly incorporated the USP claim on
their store brands produced by Leiner.
-- The USP standard raised the quality bar for the entire industry to a
much higher level.

"To ensure that our processes, facilities, and products consistently comply with USP and GMP standards, we have our quality procedures verified by independent auditors," said Dunn. Leiner has been certified by Shuster Laboratories as complying with: FDA proposed GMPs for dietary supplements; the USP Manufacturing Practices for Nutritional Supplements (USP 26 NF21); and drug manufacturing GMPs (21CFR 210, 211).

Recently, Leiner instituted the only known Hazard Analysis Critical Control Point (HACCP) program in the industry. In line with the FDA's concerns about bio-terrorism, HACCP Certification assures product safety from the processing of the agricultural raw materials to the packaging of the product.

"It is gratifying to work with a manufacturer that takes its quality position as seriously as Leiner," said Eugene Damon, senior vice president of Shuster Laboratories, an independent R&D, quality assurance and product-testing lab. "Not only are Leiner's facilities in compliance, but its products also consistently meet 100 percent of label claim as defined by DSHEA."

Leiner upholds this commitment to quality manufacturing to ensure that its retail partners offer the consumer the highest quality products available. As such, Leiner operates and is in full compliance with the highest DSHEA standards for dietary supplements.

About Leiner Health Products

Leiner Health Products is a leading private label supplier of self-care solutions to mass-market retailers. Headquartered in Carson, Calif., Leiner is the nation's largest private label vitamin manufacturer and a leading private label manufacturer of OTC products. The company provides the nation's leading retailers with more than 3,000 private label products.

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