Food and Drug Administration Regulates Sale of Semen

In 2005, the FDA began regulating the sale of semen within the United States (though regulating might be too strong a word - they basically institutionalized practices that had already become the norm within the cryo banking community). Cryo banks that don't comply with FDA regulations don't risk being shut down but are not allowed to say they're FDA approved, which in the highly competitive sperm-banking business, might mean losing a leg-up to a competitor.

This is relevant to all things donor insemination, of course, because as mild as the FDA's regulations might be, it's one of the few regulatory gestures made by the Federal government towards the medically assisted reproductive industry. For the most part, Federal and state governments have wanted to steer clear of any kind of regulation, intentionally leaving the details of the baby-making business in the (no doubt, benevolent) hands of the free market.

Here's the FDA's statement:

Human cells or tissue intended for implantation, transplantation, infusion, or transfer into a human recipient is regulated as a human cell, tissue, and cellular and tissue-based product or HCT/P. The Center for Biologics Evaluation and Research (CBER) regulates HCT/Ps under 21 CFR Parts 1270 and 1271. Examples of such tissues are bone, skin, corneas, ligaments, tendons, dura mater, heart valves, hematopoietic stem/progenitor cells derived from peripheral and cord blood, oocytes and semen. CBER does not regulate the transplantation of vascularized human organ transplants such as kidney, liver, heart, lung or pancreas. The Health Resources Services Administration (HRSA) oversees the transplantation of vascularized human organs.

Parts 1270 and 1271 require tissue establishments to screen and test donors, to prepare and follow written procedures for the prevention of the spread of communicable disease, and to maintain records. FDA has published three final rules to broaden the scope of products subject to regulation and to include more comprehensive requirements to prevent the introduction, transmission and spread of communicable disease. One final rule requires firms to register and list their HCT/Ps with FDA. The second rule requires tissue establishments to evaluate donors, through screening and testing, to reduce the transmission of infectious diseases through tissue transplantation. The third final rule establishes current good tissue practices for HCT/Ps. FDA's revised regulations are contained in Part 1271 and apply to tissues recovered after May 25, 2005. The new requirements are intended to improve protection of the public health while minimizing regulatory burden.

Fertile Markets

Here's a fun little precis I found online when I googled: international human semen trade. This guy really knocked himself out with all the double-entendres. Wouldn't you? Enjoy:

Not all trade barriers concern steel, corn and coffee. Major human semen exporters like the United States say they are having a hard time penetrating Mexico's sperm market. Human semen trade is an estimated US$100 million industry worldwide, but Mexico is abstaining from entering the market and using its own internal resources. Mexico has not banned the imports outright; however, strict federal standards and restrictions keep foreign semen out of the country. The Fertility Institutes, a semen supplier with offices in both the United States and Mexico, has been unable to swap semen across the border among its clinics. "Not because of a lack of need or desire, but because of the inability to meet all requirements of both countries, as well as FedEx and other international shippers," says Fertility Institutes' Jeffrey Steinberg. Meanwhile, strong demand in Canada for human semen on recent years--which sells for about the same price as cattle semen in the open market--eased border restrictions for sperm imports from the United States. Leading U.S. semen trader Xytex has shipped its U.S. genes to Canada and several countries in Europe since 1983, but the company says getting across its southern border poses a much bigger challenge. "It's virtually impossible," says Holly Fowler, spokesperson for Xytex. Foreign exporters trying to ship their specimen into Mexico apparently must overcome the country's main barrier to entry into the sperm market: national pride.