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Quality Control
1.Do you manufacture your own products? How does Herbalife guarantee quality control and quality assurance of its products?
Herbalife owns two manufacturing facilities, in Lake Forest, California, and Suzhou, China. In addition, we contract with manufacturers in the United States, Europe, South America and Asia. Our goal is to continue to expand company-owned manufacturing capabilities, while also partnering with select high-quality manufacturers.
2.What government entities regulate Herbalife® products?
Within the United States, the Food and Drug Administration (FDA) regulates our conventional foods, dietary supplements, and cosmetics under the Food, Drug and Cosmetic Act, as amended. Herbalife® products contain ingredients either already recognized as safe or otherwise specifically permitted.
All Herbalife® products sold in the United States are labeled according to FDA regulations and must be manufactured in accordance with established quality standards. Vendors are periodically inspected and audited by Herbalife in accordance with the company’s written quality assurance procedures. All Herbalife® food and supplement products, as well as its facilities, are subject to FDA inspection and enforcement authority at all times.
Outside of the United States, we comply with and are regulated by the various ministries of health and food standards agencies in the additional countries where we do business.
Herbalife must submit notifications to the FDA about every dietary supplement product displaying structure/function claims. Herbalife must also report to the FDA all serious adverse events reported to be associated with its dietary supplements.
3.Do Herbalife® products cause liver disease?
No. Two articles appeared in the October 2007 issue of Journal of Hepatology allegedly associating Herbalife® products with liver disease. No product or specific ingredient was identified although the articles theorized that our products could contain toxic substances that could be causative. In fact, extensive testing of our products has repeatedly shown that none of the substances mentioned in the articles were in any of the products, with the exception of green tea, which is present in some products at nutritional levels commonly consumed throughout the world. Detailed reviews by 25 governments found no reason to take any regulatory action.
We have submitted a rebuttal to the journal. Herbalife is sometimes wrongly thought to be a medicinal herb company when, in fact, none of our products are sold or marketed for treating, curing or mitigating disease anywhere in the world.
4.Are Herbalife products safe?
Herbalife is committed to setting the standard by which all nutrition companies are measured. We are advancing the science of nutrition through scientific research conducted around the world. Since 2003, we've increased our research and development expenditures dramatically to advance the product-development process.
In 2011 the company spent approximately $25 million on the combined scientific areas of R&D, technical operations, scientific affairs, quality assurance/quality control, product safety and compliance. The company spent an additional $11 million on nutrition affairs, product licensing and strategic sourcing.
At Herbalife, there are 180 scientists on staff, of which 19 have PhDs. The company’s internal staff is supplemented with 30 consulting scientists, all with PhDs. From January 2011 to date (March 2012), the company has initiated 12 clinical studies, of which five relate specifically to the Formula 1 product.
Note: Formula 1 is an existing product, which excludes it from R&D expenses reported under current FASB rules, which only allow expenses to be classified as R&D if they relate to new products or "significant" changes to existing products.
Product integrity, safety and efficacy have always been Herbalife’s top priorities. We invest in new technology and research as part of our commitment to providing innovative, science-based nutrition products. Ingredients used in our products are also found in many foods. Our materials (including botanical ingredients) are globally sourced from reputable suppliers and our products are manufactured in accordance with established quality standards. Product quality is verified at our in-house laboratory with state-of-the-art testing equipment. The Herbalife quality team conducts regular audits and inspections of suppliers and contract manufacturers to ensure compliance.