FDA’s policy of self-determination provides ‘safe passage’ for one of the worst additives ever

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August 13, 2013

Who decides if food additives are safe before they end up in that frozen dinner, canned soup or cake?

If you said the Food and Drug Administration, you’re only about 57 percent right.  And the rest? According to a new study, the approximate 43 percent of the more than 10,000 additives in the U.S. food supply that are regarded as Generally Recognized as Safe, or GRAS, had their safety determined by the manufacturer!

But wait, there’s more! Of that 43 percent, the study says, approximately 1,000 “GRAS” additives ended up in food without FDA knowledge (which is A-okay with the agency).  And for the icing on the additive-laden cake, those manufacturers that do decide to voluntarily inform the FDA get to pick who conducts the safety review of the additive.

The study, “Conflicts of Interest in Approvals of Additives to Food Determined to be Generally Recognized as Safe,” published last week in JAMA Internal Medicine stated that, “The lack of independent review in GRAS determinations raises concerns about the integrity of the process and whether it ensures the safety of the food supply…”

Professor, author and nutrition blogger Marion Nestle, who wrote an accompanying editorial to the study, put it a bit more bluntly, stating, “as long an not too many people roll over dead after eating foods with new additives, nobody will ever have a clue whether the additive is safe.”

The food additive approval process, as explained by Nestle, appears to be a downhill trip of FDA oversight. In 1958, she says, “Congress passed a law requiring companies introducing a new additive to provide evidence of safety before putting it on the market.” But as many food additives had been consumed for a very long time, an exemption was made for these GRAS substances so they didn’t require any premarket approval. If a manufacture believed its additive met GRAS requirements, they could petition the FDA, as many did.

However, in 1997, a fast-track additive-to-market plan was proposed by the agency. With the exception of color additives, “food companies could—at their own discretion—notify the FDA that experts generally agreed that a new additive was safe,” Nestle says in her editorial, adding that these rules “proposed 16 years ago, have never been issued in final form and are still pending.”

“Most complained about additive ever” makes a GRAS comeback

Since “formal” GRAS determinations by the FDA were phased out in 1997, the current method, should a manufacturer choose to notify the agency at all, is to send a GRAS notice to the agency that includes the name of the additive, the “notifier” who is making the GRAS determination, its intended use and the basis for determining that the substance is safe for food use.

The FDA’s “GRAS notice inventory,” is all online, including the agency’s usual response, known as the “no questions” letter. Included in that “inventory” is one additive that many people had thought was gone for good – the infamous fake fat substitute known as olestra (or Olean)

Called “the most complained about additive ever,” by Center for Science in the Public Interest (CSPI) and included among Time magazine’s “50 worst inventions,” olestra may also be the only ingredient to ever have required a warning label on products containing it noting that consumption “may cause abdominal cramping and loose stools,”  or to have been targeted by comedians for a related side effect known as “anal leakage.”

It also was one of the more expensive additives brought to market, with Procter & Gamble having spent around $500 million on it since its invention in 1968. In 1987 the company petitioned the FDA to have it “officially” approved as a food additive which it finally achieved in 1996, but only for chips and crackers and amid unresolved safety and testing questions.

By 1997, P&G and CSPI had each submitted over a thousand adverse reaction reports to the FDA, many for severe diarrhea, fecal incontinence and abdominal cramps, and by 2002, CSPI noted that such reports were approaching the 20,000 mark, “more than all other food additive complains in history combined.”

Given all the complaints and jokes about this indigestible ingredient – which also interferes with the body’s ability to absorb certain essential vitamins – one might have thought olestra would have been long consigned to the scrap heap of failed products. But actually, it’s still out there – only without those prominent label warnings to scare off consumers. And apparently, P&G is not about to simply write off its investment, having filed a 673-page self-determination of GRAS status with the FDA in 2010 for the use of olestra in a wide variety of additional ready-to-eat foods, including mayo, ice cream, bread, cakes and cookies (all with no warning notices on the package).

A short eight months later, the FDA responded with a “no questions” letter, indicating that the agency would not  challenge P&G’s “conclusion that Olestra is GRAS under its intended conditions of use.”

All of which is yet more proof  of why it’s advisable to read ingredient labels before purchasing any processed food product – and why, seeing how the FDA has deferred to manufacturers’ judgments in regard to the safety of food additives, the adage “let the buyer beware” has never been more applicable.