David Vanderveen makes a number of very disturbing charges against the Food and Drug Administration in “Local Currents,” May 13.
He claims the agency “has hardly been a friend to business owners,” and is “the Deathstar of beverage oversight.” It’s enough to make one throw up one’s hands and ask, “Why should we have an FDA?”
The first Food and Drug Act was passed in 1906 in response to concerns about contaminated foods and meats. In 1938 a new pharmaceutical product, Elixir Sulfanilamide, killed 107 adults and children by slow, painful death before it could completely be removed from drugstores. Within months Congress passed the 1938 Food, Drug, and Cosmetic Act, and for the first time pharmaceutical companies were required to provide adequate scientific proof of safety before putting a new drug on the market, and warnings and directions for use on each package.
In the ‘50s and ‘60s, 10,000 children in 46 countries were born with limb deformities due to their mothers’ use of Thalidomide, prescribed as a sedative during pregnancy. Only through the persistent efforts of FDA pharmacologist Dr. Frances Kelsey was Thalidomide blocked from approval and marketing as Kevadon, sparing thousands of potential U.S. victims. As a result, Congress passed the Kefauver-Harris Amendments to the 1938 FDC Act, creating the strengthened modern FDA procedures to insure food and drug safety.
These accounts of drug dangers are not simply historical anecdotes. The FDA monitors drug safety every day. In 2008, intentionally adulterated heparin from China got into a Baxter product and resulted in the deaths of 81 Americans. Americans should be grateful that these agencies are in place.
Under the FDC Act, a substance added to food is considered an “unsafe food additive” unless it has been approved by FDA or is “generally recognized as safe” (GRAS). Caffeine added to an alcoholic beverage in any amount is unsafe, whereas caffeine added to a cola type beverage in amounts less than 0.02% is considered GRAS, and therefore legal. Vanderveen’s concern about the “Deathstar of beverage oversight” is misplaced. Some of these “energy” beverages contain as much alcohol in a single can as is contained in four cans of beer. One is nicknamed “blackout in a can”. Nine college students in Washington state were hospitalized last year, sickened by the alcohol caffeinated drink Four Loko, according to school officials. In response to the FDA action, some manufacturers of caffeinated alcoholic energy drinks are reformulating their products. Vanderveen’s energy beverages are not subject to these FDA restrictions because they contain no alcohol, but they could conceivably face heightened competition from such reformulated products.
Manfred E. Wolff, Laguna Beach