First It’s Not Safe, and Then It Is! The FDA Position on Melamine May Give Us All a Case of Whiplash

Melamine was first synthesized by a German chemist in 1834, and melamine resin is used in Formica for countertops and dry erase boards as well as flame retardants. A 1958 patent described the use of melamine as a non-protein nitrogen (NPN) for cattle. Melamine is sometimes illegally added to food products in order to increase the apparent protein content. Standard tests that estimate protein levels by measuring the nitrogen content can be misled by adding nitrogen-rich compounds such as melamine.
Melamine is described as being “harmful if swallowed, inhaled or absorbed through the skin.” An FDA toxicology study—conducted after recalls of contaminated pet food—concluded that when melamine and cyanuric acid are absorbed into the bloodstream, they concentrate and crystallize, blocking and damaging the renal cells; this can cause acute kidney failure. Chronic exposure may cause cancer or reproductive damage in both animals and humans.
Between the late 1990s and early 2000s, both the production and consumption of melamine grew considerably in mainland China. Surplus melamine has been an additive in feedstock and milk in mainland China for several years now because it can make diluted or poor quality material appear to be higher in protein. In September 2008, nearly 53,000 people became ill from melamine in powdered milk, with more than 12,800 hospitalizations and four infant deaths. Since then, the government of China has taken steps to curtail its use.
Until the 2007 pet food recalls, melamine had not routinely been monitored in food except in the context of plastic safety or insecticide residue. Following the 2008 health crisis in China, the Joint Research Centre of the European Commission set up a website about methods to detect melamine.

The FDA then issued a Health Information Advisory to proactively assure American consumers that there was no known threat of contamination of infant formula with melamine from companies that met their requirements to sell infant formula in the US. According to the FDA Website, the FDA continued to sample products for melamine, and added that the agency was unable to establish that melamine was safe at any level in infant formula.

Three weeks ago, the Wall Street Journal reported that trace levels of melamine had been found in US-made infant formula and in a few samples of nutritional and medical supplements made by US infant formula manufacturers. It was then revealed that the FDA’s sampling of infant formula had found that up to 90 percent of infant formula sold in the US is contaminated with trace amounts of melamine. In a shocking reversal of its position, the FDA then officially declared melamine to be safe in infant formula as long so the contamination is less than 1 part per million!

The FDA’s test on Mead Johnson infant formula found it contained melamine levels over one thousand percent higher than the contamination level it expected to see as a byproduct of the manufacturing equipment—245 parts per billion. The FDA then stated “Melamine is not naturally occurring and is not approved to be directly added to food in the United States. However, melamine is approved for use as part of certain food contact substances. Low levels of melamine are present in the environment and trace amounts may occur in certain food commodities as a result of approved uses.”

This appears to directly contradict their previous statement that any contamination of infant formula with melamine was not safe. Consumer safety interests clearly take a back seat to vested industry interests at the FDA. As AAHF president Hunter Lewis notes, “The FDA says there is no safe level of melamine. Baby formula is found to be contaminated with melamine. Suddenly the FDA says it’s safe—with no science to back up it’s change in position. And the FDA has not bothered to test other dairy products for melamine.”
Chairwoman Rosa DeLauro (D-CT) of the Agriculture-FDA subcommittee strongly rebuked the FDA’s action. She noted that while the European Union is acting to ban melamine contaminated products imported from China, the FDA has set an acceptable level for melamine in food. She indicated that FDA’s action appears to condone the intentional contamination of food.
The melamine scandal is one more important reason that it is time to reform the FDA. www.ReformFDA.org is a program of the American Association for Health Freedom in concert with numerous other organizations. AAHF believes that the FDA is a broken agency that needs a complete reform and restructuring.

As presently run, the FDA:
• obstructs medical science and innovation;
• forbids and censors the communication of legitimate, peer reviewed scientific research;
• protects entrenched medical monopolies which pay its bills and hire its employees;
• interferes with the rights of consumers to learn about good science (especially relating to food and supplements) that could prolong and save lives and promote health; and
• unnecessarily drives up the cost of healthcare to the point where employers can no longer afford to hire and the entire American economy is threatened.

What is needed under these circumstances is not incremental reform, but complete reform—a thorough overhaul of every part of the FDA in order to rebuild the American healthcare system and once again make it the envy of the world. Visit www.ReformFDA.org to learn more and sign our petition.