According to the complaints, the active ingredients - bulk aspirin, acetaminophen, or ibuprofen compounds - that respondents processed into tablets are or were made outside the United States. The FTC has explained that the imported bulk ingredients comprise a substantial percentage of total manufacturing costs and impart the crucial analgesic quality to the OTC products at issue. According to the FTC, all of the claims are express statements made on the companies' packaging and labeling, which in some instances were accompanied by pictures of U.
The Commission's complaints do not allege that all of the respondents' private label aspirin, acetaminophen, and ibuprofen brands are mislabeled, but only that certain products for certain customers have been improperly labeled. In addition, the FTC did not uncover any evidence that the drugs were adulterated or contained harmful substances.
Perrigo Company , based in Allegan, Michigan, is the nation's largest manufacturer of OTC pharmaceutical products for the store brand market.
Perrigo manufactures and sells aspirin, acetaminophen, and ibuprofen tablets for private label customers such as Wal-Mart, Kmart, Target, and Safeway. Leiner Health Products, Inc. LNK International, Inc. Pharmaceutical Formulations, Inc. The company manufactures, labels, sells, and distributes products containing aspirin and acetaminophen sold at retail bearing private brand names for customers such as Kmart, Duane Reade, Eckerd Drug Company, and Walgreen Co.
Each of the proposed settlements would prohibit the respondent from misrepresenting the extent to which its OTC drug products containing an analgesic are made in the United States. As in the FTC's prior "Made in USA" cases, the settlements provide a "safe harbor" that allows the respondents to represent that a product is made in the United States so long as all, or virtually all, of the ingredients or component parts of the product are made in the United States and all, or virtually all, labor employed to manufacture the product is performed in the United States.
The orders would allow the respondents to represent that a product containing an imported active ingredient is "Processed in the United States with Foreign Ingredients" when the representation is true and is used to describe a product that has been significantly processed in the United States.
In addition, each of the settlements contains a number of recordkeeping and reporting requirements to assist the FTC in monitoring compliance with the orders. In December , after a comprehensive policy review, the FTC concluded that "Made in USA" advertising and labeling claims must continue to conform to the "all or virtually all" standard that the Commission traditionally has applied.
Under this standard, unqualified U. In addition, the agency issued an Enforcement Policy Statement outlining the factors the Commission will consider in determining whether a U. I have a bottle of extra-strength, mg.
Sunmark pain reliever in my desk drawer that the label says is a generic equivalent of extra-strength Tylenol. I take it because I spend far too much time staring at a computer screen. But where does it come from? As for who actually made the little white pills, or where, no information is provided.
A call to the customer-service line given on the website got me nowhere. While I waited for a response, I did a little poking around on my own to see what kind of paper trail exists for Sunmark acetaminophen. Last year, contaminated batches of the blood thinner heparin killed more than a dozen people. The active ingredient in the drug was traced to a factory in Changzhou, west of Shanghai. A McKesson spokesman finally got back to me by e-mail.
Perrigo has facilities all over the world. The company says the active ingredients for its various products come in part from plants in Israel, Germany and China. But apparently it also gets its supplies elsewhere. In , Perrigo recalled 11 million bottles of acetaminophen sold under various brands. Small metal fragments were found in some batches. Arthur Shannon, a Perrigo spokesman, declined to identify the supplier or its country of origin. Nor would he comment on whether Perrigo contracts with Chinese firms for its production of acetaminophen.
The Pharmaceutical Research and Manufacturers of America, an industry group, says the federal government insists on such quality controls for all pharmaceuticals sold in the U. But it seems to me that if the U. Department of Agriculture can boost market transparency by letting people know that apples come from New Zealand or that a fish was raised on a farm and not in a babbling brook, the FDA can require similar openness when it comes to pharmaceutical products.
Moreover, the label would include a Web address where more-detailed information could be obtained, including a list of the countries of origin of all active and inactive ingredients, along with contact information for the various manufacturers and suppliers.
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