On August 1st, Proctor & Gamble won approval to remove the following warning label from products containing Olestra, a calorie-free substitute for fat:

"This Product Contains Olestra. Olestra may cause abdominal cramping and loose stools. Olestra inhibits the absorption of some vitamins and other nutrients. Vitamins A, D, E, and K have been added."

Why the label?

Olestra is a good tasting molecule that's too big to be digested. It passes right through you. If you have too much, it may require a trip to the loo. Reading a label with the phrases "abdominal cramping" and "loose stools" was not seen as positive by many consumers.

P&G; didn't see the label as favorable either, especially since they first starting talking to the FDA about Olestra approval in 1971. By 1996, they had spent hundreds of millions of dollars¹ on studies ², lobbying, and marketing to finally get the product on the shelf—-and they still ended up with an awful, but accurate, label.

Perseverance

The potential effects³ of the product haven't changed, neither has the perseverance of P&G; to promote it. In citing its decision to remove the "loose stools" labeling, the FDA gave the following reasons:

1. Post-market studies showed consumers are aware of Olestra and its potential GI effects.
 
2. Post-market consumer studies showed that consumers were confused by the required label because they did not understand that the label meant there would be no loss of vitamins. These post-market studies also indicated that consumers erroneously believed that vitamins and minerals not affected by Olestra would be lost.
  
3. At a 1998 FDA Foods Advisory Committee meeting there was agreement that an asterisk-linked statement on the ingredient panel about added vitamins A, D, E, and K would be more useful to consumers.
   (FDA Changes Labeling Requirement for Olestra)

The FDA was created to promote public health.⁴ When in doubt, err on the side of protecting the public, "do no greater harm", et cetera, et cetera. But despite the FDA's honorable mission statement, I imagine the P&G; marketers just kept coming back until the FDA workers couldn't stand it any more. Once I went for an extended hike in Alaska and by the end I didn't even have energy to wave the flies off of my face--I let them stay there, waiting for the end of the trail, waiting for them to simply go away. Imagine the poor FDA workers with lawyers and lobbyists breathing down their necks. In such an atmosphere, I might also cave in. I'm not sure how the FDA justifies their reasons above but it might be something like this:

1. Post-market studies showed consumers are aware of Olestra and its potential GI effects.

   Justification: Consumers have committed the Olestra warning label to memory and will pass on the knowledge to their children in the form of oral histories.

2. Post-market consumer studies showed that consumers were confused by the required label because they did not understand that the label meant there would be no loss of vitamins. These post-market studies also indicated that consumers erroneously believed that vitamins and minerals not affected by Olestra would be lost.

Justification: Thousands of products have vitamin labels. After a while, they simply confuse readers who can care less about vitamins. They should be removed.

3. At a 1998 FDA Foods Advisory Committee meeting there was agreement that an asterisk-linked statement on the ingredient panel about added vitamins A, D, E, and K would be more useful to consumers.

   Justification: Again, consumers are confused when products strip away vitamins so it's not that important. Olestra was shown to reduce carotenoid absorption at rates over 50%⁵. This was never put on the label and no consumers complained. Plus, removing the warning leaves more room for pictures.

(Note: The FDA Foods Advisory committee, immune to any kind of influence or payoff from P&G;, voted with their hearts and their minds. Knowing that P&G; would last longer than their careers and would provide some type of future financial remuneration had no influence.)

I apologize for the digression into Olestra. It's just staggering the amount of time and money that has gone into a food additive. In simpler times, there wouldn't be so much regulation and fighting back and forth about studies. Instead of years (and in this case decades) of approval processes, the head of P&G;, top marketers, and their extended families would simply be asked to eat "regular" helpings of Olestra for 18 months. If a neutral doctor declared them OK, then fine, let them sell it. Instead we are left with the imperfect FDA to regulate products. In this case, instead of using biology-based science to justify the labeling change, they used P&G; marketing documents.

High from their success, the P&G; marketers may be spending this winter working on convincing Canada to chance its stance. Canada Health, an organization with the same responsibilities as the FDA, has banned Olestra--with or without a label.

¹  In Food Politics, NYU Nutrition Professor Marion Nestle estimates that Olestra had cost $500 million. (p. 349)

²  P&G; has spent substantial time and money on studies. However, the studies had general faults in regard to testing Olestra's effects on human health. Below is a criticism of P&G;'s studies as printed in the 1998 U.S. Department of Health's Nov 1998/Dec 1998 Public Health Report:

CRITIQUES OF SCIENTIFIC STUDIES CONDUCTED BY P&G;:

• Duration too short
• Doses too low (unlike usual food additive testing)
• Numbers of subjects insufficient
• Statistical power inadequate
• Insufficient focus on frequent users
• Lack of confirmation by independent investigators

³  Also printed in the 1998 U.S. Department of Health's Nov 1998/Dec 1998 Public Health Report:

PHYSIOLOGICAL EFFECTS:

• Gastrointestinal problems (pain, gas, diarrhea, leakage) in some people
• Reduced absorption of fat-soluble vitamins
• Reduced absorption of carotenoids
• Uncertain effects of reduced absorption on disease risks
• Efficacy in inducing weight loss or reducing risk factors unknown

⁴  The top mission of the FDA is to "To promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner"

The full mission of the FDA may be found at http://www.fda.gov/opacom/morechoices/mission.html

⁵  Stampfer MJ. Willett WC. "Olestra and the FDA." New England Journal of Medicine. 335(9):669; discussion 670, 1996 Aug 29. UI: 8692244

• Although Olestra will be supplemented with vitamins A, D, E, and K, regular use of even small amounts of Olestra markedly reduces the levels of other fat-soluble substances -- notably, carotenoids. In one Procter & Gamble study, subjects were given 8 g of Olestra each day, which is less than the amount in 1 oz (28 g) of potato chips. After a period of several weeks during which Olestra was consumed at each meal, carotenoid levels were markedly reduced. [1] Just 3 g of a similar sucrose-polyester fat substitute (equivalent to about six potato chips), taken with one meal per day, also reduced carotenoid levels (Table 1)
• Table 1.-Effect of Sucrose-Polyester Fat Substitutes on Blood Carotenoid Levels .