“These safety concerns are reflected in Congress' enactment of the drug and import provisions of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 301 et. seq., which strictly limit the types of drugs that may be sold within and imported into the United States and who may import them. Congress enacted these provisions to create a relatively "closed" drug distribution system, which helps ensure that the domestic drug supply is safe and effective.”

- Excerpts from February 6, 2008 letter to Mayor Don Ness of Duluth, Minnesota from Randall W. Lutter, FDA Deputy Commissioner for Policy.

“A yearlong U.S. Food and Drug Administration (FDA) investigation into drugs mailed to the United States from foreign countries suggests that consumers may be buying drugs online to avoid the need for a prescription from their physician. The FDA sampling of imported drugs also indicates that consumers continue to spend money unnecessarily on potentially risky drug products bought over the Internet.”

“The investigation found 88 percent of the 2,069 drug packages examined appeared to be prescription medicines available in the United States. Of the remaining products, some were dietary supplements, some were foreign products with labeling that was illegible or incomprehensible, and some were medications not available in the United States. More than half (53 percent) of the products sampled have FDA-approved generic versions, likely sold at lower costs, according to earlier studies that have shown generics in the United States to be generally cheaper than a comparable drug in Canada or Western Europe.”

"The data lead us to believe that many people are buying drugs online not to save money but to bypass the need for a prescription from their doctor since these Web sites typically do not require the purchaser to have a prescription. In essence, they seem to be getting and using prescription drugs without a prescription, an intrinsically risky practice."

- Randall Lutter, Ph.D., FDA's Deputy Commissioner for Policy.

“In general, a Web site can appear legitimate, but in fact be a front for an illegal operation. FDA urges consumers to beware of unregulated Internet drug sellers, because many of their products might not contain the correct ingredients and could contain toxic substances. Several drugs found in this survey require special monitoring by physicians or other health care professionals for potential adverse events and to ensure their effectiveness. These include antibiotics, antidepressants, the blood thinner warfarin, and levothyroxine (a thyroid replacement hormone).”

- Excerpts from November 1, 2007 Food and Drug Administration Press Release, FDA Says Consumers Continue to Buy Risky Drugs Online

“The U.S. Food and Drug Administration continues to warn the American public about the dangers of buying medications over the Internet.”

“New data collected by the FDA show that consumers who are trying to save money on prescription drugs don’t need to take chances by buying prescription drugs from foreign Internet sites, because low-cost generic versions are available in the United States. This finding also may be an indication that some consumers are likely buying foreign drugs this way to avoid getting a prescription from their doctor or health care professional, since many Web sites do not require a prescription. “

“Recent examinations of a sample of drugs shipped to U.S. consumers found several drugs are associated with higher risks and are more dangerous to the consumer if used without the supervision of a doctor or health care professional. For example, warfarin (an anticoagulant or blood thinner) is a medication that requires very close monitoring to prevent stroke or death. Another example is amoxicillin and other antibiotics that should not be used for self treatment to reduce the risk of antibiotic-resistant infections. Levothyroxine, a thyroid replacement hormone, also requires close monitoring to ensure effective treatment. Another blood thinner, clopidogrel, may pose increased risk of cardiac events, such as heart attack if used in sub-optimal doses, which might be found in imported tablets.”

“Consumers are also at risk if the drugs are not properly labeled for safe and effective use. For example, alendronate sodium, which is used to treat and prevent osteoporosis, should include information warning patients of significant side effects if it is not taken appropriately. Imported eye drop preparations may not have been manufactured under proper conditions to ensure sterility, leaving patients susceptible to contamination that may result in serious infections. These are only a few examples demonstrating the importance of obtaining FDA-approved drugs and health care provider monitoring.”

- Excerpts from July 2, 2007 Food and Drug Administration Press Release, FDA Finds Consumers Continue to Buy Potentially Risky Drugs Over the Internet: Practice Puts Consumers at Risk and May Be More Expensive than Domestic Purchasing

“An FDA operation found that nearly half of the imported drugs FDA intercepted from four selected countries were shipped to fill orders that consumers believed they were placing with "Canadian" pharmacies. Of the drugs being promoted as "Canadian," based on accompanying documentation, 85 percent actually came from 27 countries around the globe. A number of these products also were found to be counterfeit.”

“This operation suggests that drugs ordered from so-called ‘Canadian’ Internet sites are not drugs of known safety and efficacy,” said Dr. Andrew von Eschenbach, Acting FDA Commissioner. “These results make clear there are Internet sites that claim to be "Canadian" that, in fact, are peddling drugs of dubious origin, safety, and efficacy. We believe that these ‘bait and switch’ tactics-offering patients one thing and then giving them something else- are misleading to patients and potentially harmful to the public health.”

“FDA conducted its operation, named “Operation Bait and Switch,” over a few days in August 2005 at JFK Airport in New York City, Miami International Airport, and Los Angeles International Airport. FDA examined all mail parcels suspected of containing pharmaceuticals sent from four countries-India, Israel, Costa Rica, and Vanuatu-that FDA had previously noticed were sources of drugs apparently ordered from pharmacies alleged to be Canadian in origin. Out of nearly 4,000 parcels examined, almost 1,700 or about 43 percent had been ordered from “Canadian” Internet pharmacies and were represented as being of Canadian origin. “

“However, only 15 percent of the “Canadian” drugs in the parcels examined actually originated in Canada. The remaining 85 percent were manufactured in 27 different countries. In addition to having been falsely promoted as being of Canadian origin, many of these drugs were not adequately labeled in English to help assure safe and effective use.”

“Thirty two of the pharmaceuticals sampled, representing three distinct drug products, have been determined to be counterfeit. FDA is working closely with the Canadian drug regulatory and law enforcement authorities on this matter. FDA will take appropriate action to keep these counterfeit products out of the U.S. drug supply and pursue actions against those responsible for attempting to defraud the American public.”

- Excerpt from December 16, 2005 Food and Drug Administration Press Release, FDA Operation Reveals Many Drugs Promoted as "Canadian" Products Really Originate From Other Countries

“…we've [FDA] come back today with the real examples you've asked for, drugs that are not refrigerated that must be, that have no instructions or warnings that should, that are unapproved in the United States but should be, that are smuggled in, that have no cost savings for the actual consumer and indeed, in some case, were even made in developing countries where there's no FDA regulation and no insurance of quality and real doubts about what they even are… these are the sorts of drugs that are actually coming in every day at Detroit and Buffalo and various mail facilities around the country that Americans are buying on web sites like this that are promising safe and effective U.S. produced drugs that are sold to Canada.”

“A second example I will give, this is an anti-depressant drug. It should only be dispensed in very small amounts, about 30. This is several hundred. This drug is prescribed for a relatively high-risk population for overdose. This drug should not be given in large amounts to patients. The Canadian pharmacy sent this individual about ten months worth of that drug.”

“I also have three drugs that someone bought over the Internet. They're not approved. We don't know what they are… one may be a Canadian version of Lipitor… We're not sure what it is… Whatever it is, it's not approved for use in the United States and there's no labeling or information on it as well …”

“These first three examples are drugs for osteoporosis, for glaucoma, and insulin for diabetics. They are required to be refrigerated. If they're not refrigerated, they're very complex proteins that break down and become ineffective... I'll even note that in the case of one pharmacy, the place where it says, "keep refrigerated" is where they put their label. So that is a dangerously ineffective drug. In all three cases, those came from Canada ordered over an Internet site, we believe.”

- Excerpts from June 12, 2003 testimony of William K. Hubbard, FDA Senior Associate Commissioner for Policy, Planning and Legislation, before the House Government Reform Subcommittee on Human Rights and Wellness

“Consumers can, and should, be cautious when purchasing drugs online. There is no foolproof way of checking a site’s reliability.”

“The global nature of the Internet creates special problems for effective law enforcement. Different approaches to drug approval and marketing in foreign countries further complicate law enforcement issues for U.S. officials.”

“As beneficial as this computer technology can be, the Internet also has created a marketplace for the sale of unapproved new drugs, prescription drugs dispensed without a valid prescription, or products marketed with fraudulent health claims. Consumers may have difficulty identifying which sites sell legitimate products.”

“In many cases, FDA cannot provide consumers with any assurance that the drugs purchased over the Internet were manufactured under current good manufacturing practices (cGMP) requirements even if the website appears to be based in the U.S.”

- Excerpts from March 27, 2003 testimony of William K. Hubbard, FDA Senior Associate Commissioner for Policy, Planning and Legislation before the House Committee on Government Reform.

“Virtually every shipment of prescription drugs from Canadian pharmacies to consumers in the U.S. violates the Act…such drugs are unapproved, labeled incorrectly, and/or dispensed without a valid prescription….Prescription drugs purchased from foreign countries generally are not FDA-approved, do not meet FDA standards, and are not the same as the drugs purchased in the United States. Drugs from foreign countries do not have the same assurance of safety as drugs actually regulated by the FDA…they could be outdated, contaminated, counterfeit or contain too much or too little of the active ingredient. In addition, foreign dispensers of drugs to American citizens may provide patients with incorrect medications, incorrect strengths, medicines that should not be used in people with certain conditions or with other medications, or medications without proper directions for use.”

- March 21, 2003, FDA Warning Letter to Rx Depot notifying the firm that the agency considers the firm’s operations to be a risk to the public health, and in clear violation of the drug safety laws that protect Americans.

“This policy [FDA’s Personal Import Policy] is not intended to allow importation of foreign versions of drugs that are approved in the U.S., particularly when the foreign versions of such drugs are being ‘commercialized’ to U.S. citizens…it does not change the law and it does not give a license to persons to import or export illegal drugs into the United States.”

“Virtually all shipments of prescription drugs imported from a Canadian pharmacy will run afoul of the Act…there are many potential avenues of civil and criminal liability for parties involved in violations of the Act…it is a felony to knowingly import a drug in violation of the reimport prohibition.”

- Excerpts from February 12, 2003, FDA Warning Letter to the Kullman Firm that solicited FDA’s views about potential civil and criminal liability of their health plan clients interested in importing prescription drugs from Canada to U.S. citizens.
“Legislation that would establish other distribution routes for drug products, particularly where those routes routinely transverse a U.S. border, creates a wide inlet for counterfeit drugs and other dangerous products that are potentially injurious to the public health and a threat to the security of our nation’s drug supply.”

“The [Dorgan] bill would actually create an incentive for unscrupulous individuals to find ways to sell unsafe or counterfeit drugs that, while purported to be from Canada, may actually originate in any part of the world. Canada could become a transshipment point for legitimate or non-legitimate manufacturing concerns throughout the world, and in many cases we would not be able to determine the true country of origin. For all of these reasons, we find that this provision would greatly erode the ability of FDA to ensure the safety and efficacy of the drug supply, and protect the public health.”

"...it is likely that the intended cost-savings for consumers would be absorbed by fees charged by exporters, pharmacists, wholesalers, and testing labs."

“We therefore must oppose enactment of this legislation.”

- Excerpts from July 17, 2002 letter from Lester M. Crawford, FDA Deputy Commissioner, to Senator Thad Cochran, outlining the FDA’s concerns and position on the Dorgan (S. 2244, the Prescription Drug Price Parity for Americans Act) importation legislation.

“And we talked to the Canadians just yesterday. I talked to a dozen Health Canada officials and I said if this [importation of drugs from Canada] would have happened, would you take responsibility for the safety of these drugs coming to America, and they said absolutely not. Why would they? They are not going to their citizens.”

- Excerpts from July 9, 2002 testimony of William Hubbard, FDA Senior Associate Commissioner for Policy, Planning and Legislation, testimony before the Senate Special Committee on Aging.

“Even if the Canadian system is every bit as good as ours, and I don’t know whether it is or not…the Canadian system is open to vulnerabilities by people who will try to enter the U.S. market because again that’s where the money is."

“Any country that became the entry to the U.S., there would be a concern that country would then become the transshipment point for problem drugs.”

- Excerpts from September 5, 2001 testimony of William Hubbard, FDA Senior Associate Commissioner for Policy, Planning and Legislation, testimony before the Senate Commerce Committee, Subcommittee on Consumer Affairs.

“…buying prescription drugs online from unknown foreign sources can be a risky business. As was the case here, even where a website looks legitimate, FDA has clear evidence that the Web site is dispensing misbranded drugs that are not the same quality as those approved by the FDA for sale in the United States.”

- Excerpts from July 13, 2004 Food and Drug Administration Press Release, FDA Test Results of Prescription Drugs from Bogus Canadian Website Show All Products Are Fake and Substandard.