Silicon Crunch -- An FDA Horror Story

(A bit of good-natured teasing of the FDA & EPA)

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API - Washington, D.C., June 1, 1999 ................. by Mark D. Gold

The U.S. Food and Drug Administration (FDA) announced today that it will approve the controversial new food additive, "Silicon Crunch." Silicon Crunch is a flavored filler made by combining artificial flavors with finely ground, recycled glass bottles. The product was developed by the Association of Chemical Food Manufacturers (ACFM) -- a collaboration of 12 chemical chemical and food ingredient companies.

Dr. Arthur A. Morales, Vice President of Development for the inventor, ACFM, hailed the decision as "proof that chemical company scientists can literally make anything info food!" Dr. A. Morales went on to say that "Silicon Crunch will change the way food is made. The versatility of this product is amazing! It can be mixed with a variety of artificial flavorings, colors, and sweeteners. The consistancy of Silicon Crunch can very easily be changed from crunchy to creamy by controlling the pre-treatment of the glass food materials. We believe that this will be the best-selling food additive in history!"

Dr. A. Morales responded to questions of concern about the safety of Silicon Crunch by stating that "There will always be a hysterical few who question the safety of an innovative new product. Today's decision proves that Silicon Crunch meets the FDA's stringent safety requirements for food additives."

Officials at the U.S. Environmental Protection Agency (EPA) were elated over the decision which they called "a victory for recycling." Incoming EPA Administrator, Dr. Morissa Green-Washington stated, "Recycling will only work if there is a market for recylced products. The FDA's decision opens up the market for recycled glass. Our goal is to work with industry to help create similar markets for other recycled products. We encourage the development of new markets for other waste products by food and chemical companies." Several senior EPA scientists who spoke on the condition of anonymity said that they do not share Dr. Green-Washington's views on this issue. One scientist summed up his viewpoint by stating, "The approval of Silicon Crunch sets a significant precedent in that Americans will now be eating recycled garbage. Even though it is stearlized, I do not think it is appropriate."

Considerable controversy could be seen at the FDA both before and after the decision was announced by FDA Commissioner, Dr. Herbert D. Banner. Two FDA scientists resigned in March claiming that the scientific review process has been sidetracked by political and economic goals. FDA Toxicologists Martin Fitzpatrick, Ph.D. and Elizabeth Shuller, Ph.D. held a press conference yesterday in protest of what they alledge was an "inevitable decision without any scientific basis." In a harsh criticism of the FDA Commissioner, Dr. Shuller stated that there was never any interest by FDA officials to look at the issue in a scientific way. She went on to say that "Dr. Banner refused to even consider the extensive documentation provided about the dangers of ingested glass! We were forced to consider only the scientific documents on Silicon Crunch provided by ACFM. The documentation provided by ACFM was ridiculous on the face of it, yet there was no possibility of considering evidence challenging this documentation given the rules we were forced to follow." Dr. Fitzpatrick added, "I believe that the whole process was motivated by money and that the revolving door between drug and chemical companies and the FDA has done irrepairable harm to the credibility of the FDA."

Commissioner Banner responded that "These two scientists were given every opportunity to produce reputable scientific research that has shown that ingesting heat-treated, finely-ground glass food material causes adverse health effects. They were unable to produce any studies showing that Silicon Crunch causes disease. The research they submitted showing serious adverse effects from ingesting glass particles is simply not relevent because those studies considered only normal ground bits of glass and not specially heat-treatment Silicon Crunch. The important point is that the majority of the FDA officials reviewing the product agreed that the manufacturer has met its burden of proof that it is safe."

"Silicon is already present in the body," Commissioner Banner pointed out. "It is in the tendons, cartilage, and blood vessels. And silicon is already being ingested from plant fiber and hard water. The glass food material in Silicon Crunch is simply another good source of silicon. There is some evidence that as atherosclerosis develops, silicon levels decline in the arteries. Adding Silicon Crunch to the diet may help prevent heart disease!"

In response to the allegations of a "revolving door" at the FDA between FDA officials and ACFM members, the Commissioner responded by saying, "This whole issue of 'revolving door' has been grossly overblown. Firstly, fewer FDA officials have left to work at ACFM member companies in this calendar year than in previous years. Secondly, not all FDA officials offered jobs by ACFM member companies have accepted those jobs. In fact, I was offered such a job, but turned it down because I still have important work to do as Commissioner of the FDA -- namely, developing strategies to keep herbs and supplements from stiffling the development of legitimate pharmaceuticals. Finally, former ACFM member company employees, who are now FDA officials, have not been part of all of the critical aspects of the decision-making process in the Silicon Crunch decision. These 'conspiracy theories' should not be taken seriously by the general public."

Commissioner Banner stated that the FDA took the cautious approach by creating five strict requirements which must be met by the manufacturer and other food companies using Silicon Crunch. The Commissioner provided this official FDA summary of those requirements:
  1. Three-layered filtration process must be installed to guarantee that no large pieces of glass food particulates would ever be found in Silicon Crunch. This size of these particulates are to be no more than 1/3 the size that caused bleeding gums in animal research.

  2. The Association of Chemical Food Manufacturers (ACFM) would be required to monitor any unexpected adverse reactions.

  3. ACFM would be required to design and fund research to provide continued assurance of the safety of Silicon Crunch.

  4. No dangerous products such as herbs or vitamins and minerals (above the Recommended Daily Allowance) would be allowed in products which contain Silicon Crunch.

  5. Initially, no claims of medical benefit would be allowed on the label of any food product which contains Silicon Crunch. However, claims such as "Fat Free," "Low Cholesterol," and "Low Calorie" could be allowed for such products. A petition to the FDA filed by ACFM for allowing a medical claim, "Prevents Heart Disease" is currently being examined by FDA scientists.
The food company members of ACFM are preparing to add Silicon Crunch to many of their snack products. According to Dr. A. Morales of ACFM, "Our goal is to get Silicon Crunch products on the shelves by late October to coincide with the start of Halloween candy purchasing. American children will be the first ones treated to this new wonder- product!" Dr. A. Morales went on to say that ACFM plans to quickly obtain approval of Silicon Crunch in other countries around the world that generally look to the FDA to make a sound, scientific safety evaluation.

A written statement from the American Dietetic Association (ADA) pointed out that they are still evaluating the situation. It went on to state that the ADA will work closely with ACFM officials under a grant from that organization to develop a workable Fact Sheet on the issue. In contrast, a statement from the Association of Consumers for Nontoxic Food Choices (ACNFC) claimed that the food industry has "spearheaded the destruction of the scientific method and risk assessment for the last 25 years. This included abuse of science and the politicizing of the approval and evaluation process in the cases of aspartame, MSG, olestra, acesulfame-k, rBGH and many others. The approval of Silicon Crunch merely puts the finishing touches on the destruction of the scientific method and approval process." An official of the ACNFC told this reporter that "Only a total idiot would ingest Silicon Crunch...but given what the food industry has been able to get Americans to ingest, I don't hold out much hope of preventing its widespread use."

It appears that the controversy may rage for a considerable length of time. The only agreed upon fact is that very soon many people will experience first-hand the benefits or risks of Silicon Crunch.