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PHARMAVITE LLC RESPONSE TO QUERIES ABOUT FISH OIL AND PCBS
Release date: 3/17/2010

NORTHRIDGE, CALIF– Pharmavite LLC, manufacturer of Nature Made® dietary supplements, is steadfast in fulfilling its responsibility to meet regulatory requirements and consumer expectations for safe and effective products. Specifically, the company’s omega-3 fish oil products and cod liver oil products are safe, and we believe comply with all Federal laws prescribed by the United States Food and Drug Administration (“FDA”), and individual State laws including California Proposition 65, as well as the World Health Organization (WHO) and European Commission standards. In addition, we believe they meet or exceed the supplement industry’s own exacting standards.

Nature Made's omega-3 fish oil products use only the oil from sustainable, wild ocean fish, and do not use oil from farm-raised fish. Each batch of fish oil or cod liver oil is processed using molecular distillation or adsorbent technologies to reduce PCBs and dioxins in the fish oil to trace levels, which helps assure consistency, purity and potency in accordance with the label claims for the products.

All Nature Made fish oils are required to pass the stringent industry standards of the Council for Responsible Nutrition’s Voluntary Monograph for Omega-3 Fatty Acids. These standards were created to reflect state-of-the-art processing and purification techniques for fish oil. All Nature Made cod liver oils are produced to comply with the European Commission standards. In addition, many Nature Made omega-3 fish oil products have been awarded the United States Pharmacopeia (“USP”) Verification Program mark for purity, potency and quality. The USP is an authoritative and independent, not-for-profit, standard setting organization that promotes public health. This USP verification requires ongoing third-party product testing and manufacturing inspections and audits to ensure quality.

Nature Made Omega-3 Fish Oil received a “Best Choice” rating based on a survey conducted by Environmental Defense, a leading national nonprofit organization representing more than 400,000 members, when the organization evaluated fish oil supplements for environmental contaminants.

Pharmavite believes that the initial findings presented by the fishoilsafety.com consumer group are not representative and we think are anomalous or in error with respect to our cod liver oil. It appears that the group performed one test on a single sample from a single bottle of the product. It appears that the unrepresentative sample was presented to the analytical laboratory with inadequate chain-of custody controls and without the date and time of sample collection. This unrepresentative testing cannot begin to compare with the quality control tests that are performed by our suppliers on our ingredients in the manufacturing process. For example, our fish oil suppliers regularly submit the raw materials they provide to us to an independent, expert, accredited, third-party laboratory for testing for PCBs. PCB testing is highly specialized and it needs to be conducted by experts who perform this analysis routinely. Our principal supplier of fish oil has for many years collected and tabulated a large volume of historical analytical data for their incoming crude oils and refined fish oil products.

We do not believe this lawsuit is about safety. To put the safety issue into perspective, the FDA permits significantly higher levels of PCBs to exist in everyday foods such as poultry (3.0 mcg/g or 3.0 parts per million) or fish (2.0 mcg/g or 2.0 parts per million) – which would result in consumption far in excess of the 0.09 mcg/day (or 0.09 parts per million) safe harbor level (not limit) for PCBs for fish oil supplements found in California’s Proposition 65.

The magnitude of the science supporting the benefits of consumption of fish oil far outweighs the risks from the trace amounts of PCBs found in our products. Fish oil has many health benefits. Most American diets fall short of critically important omega-3 fatty acids provided by these products. Fish oil supplements offer a convenient, inexpensive choice for consumers who want to incorporate fish oil into their diet. This lawsuit is needlessly frightening consumers. Consumers should pay close attention to this issue as it evolves. More information on Nature Made fish oil is available at NatureMade.com. If consumers have questions regarding any Nature Made products, they should call 1-800-276-2878.

About Nature Made
Nature Made® is the number one best-selling brand of vitamins, minerals, herbs and supplements, offering more than 150 of the highest-quality products nationwide. Owned by Pharmavite, Nature Made® was the first line of dietary supplements to earn a third-party quality seal of approval through the United States Pharmacopeia’s Verification Program. The dietary supplement industry is regulated by the U.S. Food and Drug Administration and the Federal Trade Commission, as well as by government agencies in each of the 50 states. Visit www.NatureMade.com for the latest news and offerings.

About Pharmavite LLC
For almost 40 years, Pharmavite has earned and maintained the trust of healthcare professionals, consumers, and retailers by manufacturing high-quality vitamins, minerals, herbs and other dietary supplements that are safe, effective and science-based. Nature Made vitamins is the number one selling brand in the food, drug, club and mass channels. The dietary supplement industry is regulated by the U.S. Food and Drug Administration and the Federal Trade Commission, as well as by government agencies in each of the 50 states.

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to the Pharmavite® LLC.® News Bureau.

Pharmavite® LLC. News Bureau
C/O Porter Novelli
1909 K Street N.W. Suite 400
Washington, D.C. 20006
877-866-2539 toll free
202-973-5858 fax
pnbpr@porternovelli.com
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