Misplaced Criticism



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?”


Here’s why.


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

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  1. David Vanderveen

    Dear Mr. Wolff,

    I would encourage you to re-read my column. Nowhere do I say that we ought not to have an FDA, which you imply in your letter.

    My point was simple: the FDA has gotten out-of-control in its oversight. Keeping poison out of food would seem to be a proper function, but attacking Cheerios for heart health claims or making blanket statements against energy drinks, which have a variety of formulas, is unwarranted and bigoted. It is absurd that my partners and I have to pay for full-time lobbyists and a week in DC to keep the FDA at bay.

    The FDA will be ineffective at keeping college kids sober and out of the occasional emergency room. As I said in an earlier column, perhaps they ought to outlaw liquor shots and red party cups too, or simply outlaw college as all of those things are related to excessive drinking and, in many cases, alcohol abuse.

    Your comment that “caffeine added to an alcoholic beverage in any amount is unsafe” is simply untrue and without basis. Irish coffees, Cuba Libre’s and Captain & Cokes are among a long list of safe caffeine and alcohol combinations that have been around for over a century. We host cocktail parties with our energy drinks with Members of Congress and their staff as well as with college students without incident.

    The FDA has a role and my column was a satirical romp regarding the absurdity of a medium-sized business from a small town having to proactively defend itself from an overzealous federal government. My charges against the FDA are entirely factual, which is unfortunate.

  2. William F. Paley

    You, Sir, are an energy drink bigot ….

    Your response is replete with fallacious arguments. It’s time the LBIndy realized your column is an MLM promotional piece, and an exercise in literary vanity.

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