Drug Importer Sues FDA for Release of Refused Shipment
A New York drug importer has filed suit against the Food and Drug Administration in a bid to secure release of a shipment of raw pharmaceutical ingredients that was refused by the agency. H&M USA filed a complaint Nov. 19 at the Eastern New York U.S. District Court, arguing FDA cited a non-existent policy on labeling of bulk active pharmaceutical ingredients (APIs) to refuse entry. The company wants the district court to order the shipment’s release, and block a CBP redelivery order.
Sign up for a free preview to unlock the rest of this article
Timely, relevant coverage of court proceedings and agency rulings involving tariffs, classification, valuation, origin and antidumping and countervailing duties. Each day, Trade Law Daily subscribers receive a daily headline email, in-depth PDF edition and access to all relevant documents via our trade law source document library and website.
According to the complaint, H&M regularly imports acetaminophen and sells it to Gemini Pharmaceuticals, which then processes the API into over-the-counter drug products sold under the label of Rugby Laboratories. But on Aug. 11, FDA decided to detain a shipment of 20,000 kg of acetaminophen being imported by H&M into Newark International Airport. FDA’s notice of action said the shipment was misbranded under Section 502(f)(1) of the Food, Drug, and Cosmetic Act, because the label didn’t include directions for the drug’s use. H&M claims the shipment was labeled under an exception at 21 CFR 201.122 that says bulk drug ingredients aren’t subject to Section 502(f)(1) labeling requirements as long as the package is marked “Caution: For manufacturing, processing, or repacking.”
In response, H&M’s customs broker submitted documentation that the shipment was being imported to be sold to Gemini, the contract manufacturer for Rugby Laboratories. This wasn’t enough for the FDA compliance officer in charge of the case. She requested end-use documentation from Gemini Pharmaceuticals and Rugby Laboratories as well. H&M complied, and put her in contact with Gemini and Rugby.
On Sept. 27, the compliance officer informed H&M that FDA had refused admission a week earlier. “The ‘end-use documentation received from the contract manufacturer Gemini and their customer/end-user appears for future or stock/inventory use,” she explained in the email. “Current guidance for bulk APIs does not permit importation for stock/inventory use.” The Sept. 20 FDA refusal notice again cited Section 502(f)(1) as the reason for refusal -- specifically the lack of directions for use -- and again said more documentation of end-use was necessary.
In its lawsuit, H&M pointed to several problems it had with the refusal. First, the fact that the shipment was officially refused because more documentation was necessary contradicts the fact that H&M, Gemini, and Rugby all provided documentation. The FDA compliance officer even cited that documentation by saying it “appeared” to show an intention of stock or inventory use. Second, FDA overreached when it made H&M put the agency in contact with Rugby, the customer of a customer, appearing to use the request “as a pretext to investigate the manufacturer's manufacturing practices which is totally beyond the control of H&M USA.” Customers will stop buying from H&M if they think it will trigger a closer look from FDA, the complaint said. H&M said it “knows of no other importer subjected to this imposition.”
Finally, the policy cited by the FDA compliance officer to refuse the shipment -- that “current guidance for bulk APIs does not permit importation for stock/inventory use” -- appears to be nonexistent, H&M said. FDA didn’t publish the guidance in the Federal Register, it said. So even if the API policy is real, FDA didn’t provide an opportunity for notice and comment required by administrative law, said the complaint.
Email ITTNews@warren-news.com for a copy of the complaint.