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Center for Drug Evaluation and Research 2002

Internet Enforcement Activities

FDA Issues “Cyber” Letters to Websites Selling Unapproved Ciprofloxacin

Internet Vendors Try to Promote Potentially Illicit Ciprofloxacin to Treat Anthrax

On November 1, 2001, FDA took steps to protect the American public against potentially useless or harmful drugs to treat anthrax infection that were being marketed by foreign Web sites in defiance of United States laws. The Agency issued warnings to 11 internet vendors abroad who were offering to American consumers ciprofloxacin, the generic name for Cipro. FDA has been unable to determine whether these products were made in accordance with U.S. specifications and, therefore, their sale and distribution in the U.S. may be illegal.

The Agency notified the recipients of the 11 “cyber” letters that FDA took several actions to halt potentially illicit drug sales that have emerged in the wake of the bioterrorist attacks in the U.S. FDA warned U.S. citizens that foreign drugs promoted on the Internet may not be approved for marketing in this country and may not be legally imported. The Agency also informed regulatory officials in the countries in which the Internet pharmacies operate that these potential violations were taking place; and advised the U.S. Customs Service that shipments from these vendors may be detained and refused entry.

FDA also identified five other foreign-based Websites that were selling ciprofloxacin despite previous warnings from the agency about the U.S. requirements applicable to the sale of prescription drugs. The agency is taking additional measures to block their exports to this country and to secure the assistance of foreign authorities to stop these illicit sales.

According to the World Health Organization, counterfeiting of drugs is a serious problem in many foreign countries. Foreign manufactured ciprofloxacin has not been approved or evaluated by FDA, and the manufacturing practices for production of these drug products has not been regulated by the agency to assure the drugs’ safety, identity, strength, quality, or purity.

FDA also warned consumers that they should be aware of the following risks associated with obtaining a prescription drug over the Internet:

  • The product could be contaminated and harmful. The product could be a counterfeit and not contain the drug’s active ingredient.
  • The product could contain the wrong dose of the drug. Without adequate screening by a health care professional, the product may not be safe and appropriate for the user.
  • The consumer may not have access to a health care professional if a serious side effect occurs after taking the product.
  • Ciprofloxacin is a powerful antibiotic that should be taken only after consultation with a health care provider. Because ciprofloxacin is associated with side effects (some of which may be serious) and may interact with other drugs, it is important to have access to the prescribing health care provider during ciprofloxacin treatment.
  • The consumer may receive no product at all after sending payment.

Federal law generally does not permit individuals to import drugs that are not approved in the U.S., including foreign versions of U.S. approved drugs. Under the agency’s longstanding policy, FDA has permitted individuals who are under appropriate medical supervision for treatment of a serious condition to bring into the U.S. small quantities of drugs that are not approved in this country, if no equivalent product is available domestically. Since an approved version of ciprofloxacin is manufactured and available in the U.S., personal importation of this drug is not permitted. Under federal law, any drug that is manufactured in the United States and exported abroad may only be re-imported into the United States by the drug’s manufacturer.

FDA Warns Pharmacies Selling Nicotine Lollipops

Three Pharmacies Found Illegally Promoting Nicotine Lollipops On Internet

On April 10, 2002, FDA issued Warning Letters to three pharmacies that were selling "nicotine lollipops" and/or nicotine "lip balm" over the Internet. The letters informed the pharmacies that FDA found their nicotine lollipops and lip balm to be illegal. Based on statements from the pharmacies' Internet sites, the products were being promoted as aids for smoking cessation or to treat nicotine addiction.

According to information on this site, the product consists of Nicotine Salicylate combined with a natural sweetener, and flavorings in a sugar-free base, and is available in 2 mg., or 4 mg. dosages. Based on this product's description on this Internet site, the nicotine lollipops are intended as an aid for smoking cessation or to reduce nicotine addiction and are considered unapproved drugs.

“Nicotine Water” Regulated as Unapproved Drug

Intended Use Causes “Nicotine Water” to be Unapproved Drug

On July 2, 2002, FDA issued a response to a Citizen's Petition submitted to the agency regarding the regulation of a product called “Nicotine Water.” Based on several factors, including statements contained in the labeling of the product, and other evidence of intended use, FDA determined that this product should be regarded as an unapproved new drug and cannot be legally marketed as a dietary supplement.

"FDA's decision underscores our commitment that consumers be protected from drug products that have not undergone our rigorous review process," said Dr. Lester M. Crawford, FDA Deputy Commissioner at that time.

The petition was submitted in December of 2001, on behalf of several groups including the National Center for Tobacco-Free Kids, the American Medical Association, and the American Lung Association. The petitioners specifically requested that the FDA classify and regulate "Nicotine Water" as a drug under the Federal Food, Drug, and Cosmetic Act (the Act), or classify and regulate this product as a food containing an unapproved food additive under the Act.

FDA has concluded that "Nicotine Water" is an unapproved drug under the Act because it is intended to treat or mitigate nicotine addiction as a smoking cessation product. Because nicotine addiction is considered a disease, FDA requires safety and efficacy data to support any claims intended to treat this disease. After reviewing the claims on the manufacturer's Internet site, which were submitted with the Citizen's Petition, FDA concluded "Nicotine Water" is an unapproved drug and may not be legally sold in the United States until the manufacturer submits a new drug application to the agency and the agency approves the application.

FDA also determined "Nicotine Water" which contains as an active ingredient nicotine or nicotine polacrilex, cannot be legally marketed as a dietary supplement. Although "Nicotine Water" is promoted by the manufacturer as a dietary supplement, this product does not meet the statutory definition of a dietary supplement. Under the Act, a "dietary supplement" does not include a product that contains an active ingredient that FDA has already approved for use in a drug. Because the nicotine and nicotine polacrilex in "Nicotine Water" are both active ingredients in FDA-approved drugs (such as Nicoderm CQ, Prostep, Habitrol, and Nicorette) "Nicotine Water" cannot be marketed as a dietary supplement. In light of these determinations, FDA notified manufacturers of "Nicotine Water" that this product cannot be marketed without new drug approval by the agency.

Warning Letters Issued for Synthetic Norephedrine HCl

FDA Warns Firms That Synthetic Norephedrine HCl is Not a Dietary Supplement

In FY 2002, FDA’s Center for Drug Evaluation and Research, Office of Compliance, issued six Warning Letters to firm’s promoting products on the Internet as dietary supplements that contained synthetic norephedrine HCl. FDA issued Warning Letters to the following firms:

Muscle Lane, Inc., Austin, Texas
Scientifically Advanced Nutrition, Marine del Ray, California
ThermoLife International, Phoenix, Arizona
ThermoLife International, San Carlos, California
21st Century Sports Nutritionals, Inc., Fort Walton Beach, Florida
Better Bodies, Winfield, Kansas

The Warning Letters stated that “Although your web site represents this product as a dietary supplement, ...this product cannot be so considered because the norephedrine HCI used in your product appears to be a synthetic compound that is not derived from any botanical source.”

The Warning Letters noted that “Synthetic norephedrine HCI is not plant-derived and cannot, therefore, be considered a constituent or extracts of a botanical source. Consequently, FDA has determined that synthetic ephedrine alkaloids are not ‘dietary ingredients’ as defined in the Federal Food, Drug and Cosmetic Act [the Act, Section 201(ff)(1)]. Therefore, products containing synthetic ephedrine alkaloids do not fall under the dietary supplement regulatory scheme. Based on its intended uses, to affect the structure or function of the body, this product is a drug within the meaning of Section 201(g) of the Act. Such products are considered drugs when their intended use is established by structure function claims, such as those that appear on your web site.”

A seventh firm, Diabetes Tea, Stow, Ohio, was promoting a product containing both synthetic norephedrine HCL and ephedrine HCl. FDA issued a Warning Letter advising the firm that both norephedrine Hcl and ephedrine HCl are not dietary supplements because the products are synthetic compounds and are not from any botanical source.

Warning Letter Issued for Promotion of Street Drug Alternatives

FDA Continues to Monitor Web Site Following Firm’s Promise to Stop Selling Certain Products

On January 2, 2002, FDA’s New England District Office issued a Warning Letter to Ms. Yamila Abraham, d/b/a Pleasure Herbs, Worcester, Massachusetts. During an FDA inspection of the firm on April 3, 4, and 9, 2001, an FDA investigator documented that the firm was selling street drug alternatives over the Internet. These street drug alternatives included products such as “Ek-sta-sis,” “yellow jackets” and other products that made claims to be alternatives to street drugs. Ms. Abraham responded to the Warning Letter stating that they would stop selling certain products and removed claims for other miscellaneous products. FDA continues to monitor the web site.

Defendant Pleads Guilty in Internet Drug Case

United States v. Sean Zhang (E.D.N.Y.) On June 25, 2002, Sean Zhang pleaded guilty before United States Magistrate Judge Boyle to one count of mail fraud. Zhang had been indicted on May 3, 2002, on ten counts of mail fraud and ten counts of introducing a misbranded drug into interstate commerce in violation of 21 U.S.C. § 331(a). Zhang sold the drug, 2,4-Dinitrophenol (DNP), for which he made weight loss claims, over the Internet. DNP, a toxic substance commonly used as a pesticide, is not approved by FDA for weight loss or any other indication.

The use of DNP as a weight loss drug in the 1930s caused numerous deaths and other serious adverse reactions and is one of the incidents that led Congress to enact the Federal Food, Drug, and Cosmetic Act in 1938. Zhang, using names such as "dnp guru" and "dnp 101," contacted potential customers through internet chatrooms and discussion boards that focused on weight loss, fitness and body-building. One of Zhang's customers died after ingesting the drug.

Over-the-Counter Drugs

Warning Letter for OTC Drugs

On February 8, 2002, FDA’s Atlanta District Office issued a Warning Letter to the President of Bass & Boney, Inc., Chapel Hill, North Carolina. The letter was issued in reference to the firm’s marketing a variety of “salt spool” products distributed under the “ACNE-LTD III,” “DERMATITIS-LTD-III,” and Rosacea-LTD III labels. According to the product labeling and promotional literature, the products contained zinc oxide, sodium chloride, sulfur, iron oxide, magnesium stearate, and polyethylene glycol as ingredients.

  • The firm’s "ACNE-LTD III" package insert (labeling) claims this product will "help to decrease inflammation of acne by dehydration...";
  • The firm’s "DERMATITIS-LTD III" package insert includes directions for use of the product. Statements of "Plaque-type psoriasis" and ‘Psoriasis vulgaris" are included in these directions;
  • The firm’s "ROSACEA-LTD III" package insert provides directions for use for the product. The Warning Letter advised the firm that “Although the active ingredients in these products are not specifically identified on the product label, the labeling distributed with the products promote the above listed ingredients for acne, rosacea, and/or dermatitis treatment. These ingredients are not permitted as active ingredients under the regulations in an OTC acne or dermatitis product.”

Because the labeling and formulation of "ACNE-LTD III," " DERMATITIS-LTD III," and "ROSACEA-LTD III," do not comply with the final regulations, these products are "new drugs" which may not be legally marketed in the United States without an approved New Drug Application. The Warning Letter also stated that these products are misbranded for failure to fully comply with the final regulations covering topical acne and/or dermatitis products.

OTC Drugs and Cosmetic Products Seized

Following Seizure District Court Grants FDA’s Motion and Imposes Costs and Proper Expenses

United States v. Various Articles of Drug…located at Gapardis Health and Beauty, Inc., (D.N.J. April 26, 2002). On October 2, 2001, the New York District officials accompanied the U.S. Marshal in a seizure of drugs at Gapardis Health and Beauty, Garfield, New Jersey. The firm is a distributor of foreign over-the-counter (OTC) drug and cosmetic products. Twenty-four products, totaling 1,035 cases valued at approximately $63,466 were seized because they were misbranded and unapproved new drugs. The products had previously been embargoed by the New Jersey Department of Health and Senior Services on February 1, 2001, during a joint investigation of the facility by FDA's New Jersey District Office, Office of Criminal Investigations, New York Field Office and New York District's Imports Operations Branch.

On April 26, 2002, the United States District Court for the District of New Jersey granted the government's motion to impose costs against a claimant attempting to withdraw its statement of interest to the seized articles before permitting the claimant to withdraw. Gapardis Health and Beauty, Inc. ("Gapardis"), had filed a statement of interest to imported articles alleged in the complaint for seizure to be unapproved new drugs. After several months of negotiations regarding settlement, Gapardis filed a "Withdrawal of Claim." Although the government did not oppose Gapardis's withdrawal of its statement of interest, FDA urged the court to construe the filing as a motion to withdraw the statement of interest and to impose costs prior to granting it. The court granted FDA’s motion and imposed costs and proper expenses against Gapardis, including expenses associated with the service of process on Gapardis, the publication of notice, and the destruction of the claimed articles.

Sun Tan Products Destroyed

Seized Articles Destroyed at Firm’s Expense

United States v. All Articles of Drug . . . Labeled As Containing L-Tyrosine (D. Minn.). On March 31, 2002, the United States District Court for the District of Minnesota granted the Defendant's Motion to Withdraw its Claim and Answer. This case concerns the mass seizure of approximately $4 million worth of sun protection products and tanning accelerator lotions in 1998, that were unapproved new drugs and were not manufactured in compliance with current good manufacturing practice. The claimant, Creative Labs, Inc., is a manufacturer of over-the-counter pharmaceuticals, including the products seized in this case.

In granting the defendant's motion, the Court reasoned that the withdrawal of Creative Labs’ claim and answer was an acceptable outcome if the defendant paid for the costs of condemnation and destruction of the seized articles. The court further held that the government would not be prejudiced by allowing the defendant to withdraw from the case because the government's pending summary judgment motion had not been decided. The court also held that the government was not entitled to a res judicata judgment against the defendant because the litigation was still in its preliminary phases. Under the Court's order, the seized articles were to be destroyed at defendant's expense and the government was entitled to its costs and other proper expenses.

Pharmacy Compounding

Supreme Court Rules on Pharmacy Compounding

On April 29, 2002, the Supreme Court in Thompson v. Western States Pharmacy, 122 S. Ct. 1497 (April 2002) ruled that the provisions of Section 503A of the Food and Drug Modernization Act of 1997 ( 21 U.S.C. § 353a) restricting advertising or promoting of compounded drugs violated the First Amendment’s free speech guarantee. The Supreme Court affirmed in part and reversed in part the ruling by the 9th Circuit, Western States Medical Center v. Shalala, 238 F.3d 1090 (9th Cir. Nev. 2001).

Warning Letter Issued Following Recall of Albuterol

Pharmacy Found Manufacturing Large Quantities of Drug Products

On September 30, 2002, FDA’s San Francisco District Office issued a Warning Letter to the President and CEO of Med-Mart Pulmonary Services, Novato, California. During an FDA inspection at the firm’s location in Bakersfield, California, on December 20 and 21, 2001, FDA investigators observed serious violations of the Federal Food, Drug, and Cosmetic Act.

Previously, in December 2001, the firm initiated a Class I recall of 5 lots of various albuterol inhalation solutions due to contamination with Serratia liquefaciens. In addition, FDA found Bacillus megaterium in the first lot of albuterol solution produced after these contaminated lots. FDA and the California State Board of Pharmacy inspected the firm in December 2001, and January 2002, respectively. Both inspections found the firm to be producing large quantities of drug products, utilizing large-scale manufacturing equipment that far exceed the usual conduct of compounding under the practice of pharmacy. In addition, the firm was using its “starter packs” and distributing these products to physicians without having received prescription orders for identified individual patients.

These activities are more characteristic of those of a manufacturer than a retail pharmacy engaged in extemporaneous compounding. The firm was informed in the Warning Letter that it appeared to be in violation of section 505 (New Drug), section 501(a)(2)(B) (Adulteration) and, certain misbranding provisions of section 502 of the Federal Food, Drug, and Cosmetic Act.

Warning Letter to Compounding Pharmacy

FDA Inspection Finds Pharmacy’s Operations Consistent with Drug Manufacturer - Not a Pharmacy

FDA’s Dallas District Office issued a Warning Letter to Unique Pharmaceuticals on October 10, 2001. The Warning Letter was issued for violations of current good manufacturing practice regulations and new drug and misbranding violations. FDA inspected the firm in August 2 - 4 and 16, and September 5, 2000. These inspections revealed serious violations of the Federal Food, Drug, and Cosmetic Act. According to the inspection report, the firm was producing copies of commercially available drug products in large batch sizes and distributing them to wholesalers for subsequent distribution to hospitals, physicians, and pharmacies, rather than directly to individual patients pursuant to prescription orders. The firm’s operations were consistent with those of a drug manufacturer and not that of an operation that produced pharmacy compounded products.

Postmarketing Adverse Drug Experience Reports

Warning Letter Issued for Violations in Reporting Adverse Events

On July 19, 2002, FDA issued a Warning Letter to Abbott Laboratories, Abbott Park, Illinois. An inspection of the firm by FDA’s Chicago District on January 7 - 28, 2002, and March 21 - April 3, 2002, disclosed deficiencies in postmarketing adverse drug experience reporting requirements [21 CFR 314.80]. The Warning Letter cited the following deviations: failure to submit serious and unexpected adverse drug experience reports in several cases to FDA within 15 calendar days of initial receipt of the information; failure to submit follow-up reports for serious and unexpected adverse drug experiences to FDA within 15 days of receipt of new information or as requested by FDA; failure to submit to FDA receipt of information or report a serious and unexpected adverse drug experience for a death associated with the drug, Meridia, to FDA within 15 days.

In addition, the letter also noted that when FDA compared the MedWatch forms in Abbott’s computer to the paper files, the comparison revealed inaccurate dates in “serious and unexpected” adverse drug experience reports. The drugs noted in the Warning Letter, in addition to Meridia, included Norvir, Biaxin, and ProSom.

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