January 24, 2005 In Defense Of The Fda: Strawberries In Winter The fact that Barry Bonds, a major league baseball play, may have used a steroid cream created reams and screams about regulation failures and setting a bad example for the young. What may be even more significant, however, is that fact that the cream penetrated Bonds' skin and caused a systemic effect. Bonds' cream may be considered an illegal drug but what about a cosmetic? The FDA's cosmetic regulations were set more than forty years ago. Cosmetics have traditionally received little attention because in the past it was wrongly assumed that such products do not really affect our health and safety. The skin was believed to be a nearly perfect barrier that prevented chemicals applied to it from penetrating the body. This belief went unchallenged until the 1960s, when the much-heralded but unmarketed miracle drug DMSO proved its ability to carry substances with it through the skin and into the body's tissues and bloodstream. Until it was shown that rabbits' eyes were adversely affected by DMSO, the drug was being promoted as a through-the-skin carrier of all sorts of medication. It has now been accepted that all chemicals penetrate the skin to some extent, and many do so in significant amounts. Today an increasingly popular way to deliver drugs is "transdermally." Would-be ex-smokers, for example, can get their nicotine "fix" through their skins by wearing patches rather than through inhaling cigarette smoke. Women can achieve birth control by pasting on a hormone skin patch. There are patches for delivering vitamin C and healing scars. The fact that Bond allegedly did not know the colorless cream contained a steroid may be true, but the FDA has almost no staff or money to regulate a multibillion dollar cosmetic industry with creams and potions that may be harmful. Anyone can go into the cosmetic business without reporting ingredients. The FDA cannot act against a manufacturer unless there is a complaint by the public. The much maligned FDA is also responsible for the protection of our food supply. Tommy Thomson, who resigned as Health and Human Services Secretary recently, left with a warning that our food supply is in danger of a possible terrorist attack. Is it the FDA's fault? We want fresh strawberries in winter and tomatoes all year round yet we have replaced many of our farms with housing and roadways and our edibles are increasingly being grown in other countries. Only a tiny fraction of the foods that enters our ports is checked by our guardian agencies. Not only do we have to worry about foreign foods with undesirable additives and residues, we now have to be protected against terroristic tampering. FDA in 2003 announced publication of proposed regulations required by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (The Act). Two regulations deal with establishing and maintaining records among food firms, and the administrative detention of foods that may pose a risk to public health. Two regulations concern the registration of food facilities and prior notice of imported foods. These regulations supposedly bolster FDA ability to protect the more than 400,000 domestic and foreign facilities that deal with food within our country. Under the rule, manufacturers, processors, packers, distributors, receivers, holders and importers of food must keep records identifying the immediate source from which they received the food, as well as, the immediate subsequent recipient, to whom they sent it. This requirement applies to almost all foreign and domestic food sources and almost all recipients of food destined for consumption in the United States. It would assist FDA in addressing credible threats of serious adverse health consequences or death to humans or animals. Can you believe record keeping tracking foods---such as those including illegal additives and contaminants--- has not been required before? Since the 1970s, when I first began writing about protection of the food supply, the FDA has tried to eliminate the overuse of antibiotics in feed to increase animal growth. The efforts have been in vain. No wonder. Forty percent of the 50 million pounds of antibiotics produced in the US are used for farm animals and crops. The inability to control the residues of more than 101 antibiotics in meat, poultry and vegetable crops that may be contributing to the increasingly alarming antibiotic resistant bacteria. In fact, The FDA's Center for Veterinary Medicine (CVM) proposed to withdraw approval of the use of the fluoroquinolone antibiotics in poultry in 2000 because chickens and turkeys develop fluoroquinolone-resistant bacterial infections, Campylobacter, the most common bacterial cause of diarrheal illness in 2 million Americans a year. It is usually uncomfortable but can be fatal. Eating poultry with fluroquinolone-resistant bacteria may lead to the development of fluoroquinolone-resistant Campylobacter infections in humans. Cross-resistance may then occur to all fluoroquinolone drugs. CiproŽ, prescribed for the bioterrorism bacterial weapon, anthrax, (and for many other infections) is a fluoroquinolone. The European Union has banned most antibiotics in feed and intends to ban the remaining four by 2006. Eighty percent of US livestock and poultry are treated with animal drugs. While the press and the public concentrate on the price of drugs--pharmaceuticals take most of the FDA's resources---we have all become amateur physicians searching the Internet for the latest treatment for what ails us. We are then exposed to direct advertising of pharmaceuticals that has led to our demanding the newest medications from our doctors. Can the FDA reign in the multibillion dollar pharmaceutical advertising that supports our consumer publications and TV programs? Some senators have tried through the years to change the regulations for the Food, Drug, Cosmetics and Devices the FDA regulates without significant success. The Agency remains a political and public whipping boy. Nothing will change unless we recognize lack of protection lies not within the FDA but with ourselves. Do our athletes have to use medications to make themselves stronger and faster than their natural talents? Do we need the latest pharmaceuticals to enhance our lives? Do we really need strawberries in Winter? For more information check: A Consumer's Dictionary of Food Additives and A Consumer's Dictionary of Cosmetic Ingredients both published by Three Rivers Press/Crown.
There are loopholes, however. "To minimize the economic burden on food companies affected" by the rule, FDA allows companies to keep the required information in any form that they prefer. The proposed rule also states that existing records can be used to satisfy the requirements of the regulations if these records contain all the required information. With respect to the immediate previous source, the specific source of each ingredient that was used to make every lot of finished food product would have to be identified if this information is reasonably available. What is reasonably available may vary from case to case, according to the FDA. If an article of food is reasonably believed to be adulterated and presenting a threat of serious adverse health consequence or death to humans or animals firms are required to provide these and other records to FDA within four hours during certain business hours, or eight hours at other times. Transporters (e.g., trucking companies, private delivery carriers, railroads and airlines) are also required to keep similar documentation-including information about all the means of transportation used.
Farms, restaurants, (including all operations that prepare food for, or serve food directly to consumers), fishing vessels not engaged in processing, and firms regulated exclusively by the U.S. Department of Agriculture, are exempted from the new recordkeeping requirements. With some exceptions, foreign facilities are excluded if their food products undergo further manufacturing/processing, including packaging, by another facility outside the United States. Retail food operations are exempted from maintaining records on immediate subsequent recipients of foods sold directly to consumers.
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