What if you took a spoonful of your morning cereal and had an allergic reaction or even felt tranquillized? But when you looked at the package labeling there were no ingredients that would seem to be red flags? Increasingly, thanks to an FDA loophole, food makers use additives and chemicals that they and not the FDA have declare “safe” and the ingredients do not appear on the labels. Sometimes the FDA does not even know they are added to the food products.
For example, according to the Natural Resources Defense Council (NRDC), the bitter alkaloid of the cacao plant theobromine can be in beverages, chewing gum, tea, soy milk, gelatin, candy, yogurt and fruit smoothies with no mention on the label. The peanut-related legume sweet lupin can be in baked goods, dairy products, gelatin, meats, and candy with no mention on the label. The chemical epigallocatechin-3-gallate (EGCG) may be found in teas, sport drinks and other beverages, says NRDC, with no mention on the label despite its links to leukemia. Nice.
How did this happen? There has been a “growth in the marketplace of beverages and other conventional foods that contain novel substances, such as added botanical ingredients or their extracts,” says the FDA. “Some of these substances have not previously been used in conventional foods and may be unapproved food additives. Other substances that have been present in the food supply for many years are now being added to beverages and other conventional foods at levels in excess of their traditional use levels, or in new beverages or other conventional foods.” Nice.
For over 50 years, everyday ingredients like vinegar, vegetable oil or sugar have been allowed in food as part of the FDA’s Generally Recognized as Safe (GRAS) program. Food companies and their supplier did not have to prove them safe and go through a lengthy approval process.
But since the late 1990s, the GRAS program has become a dangerous “honor system” in which food makers can simply declare their additives and chemicals safe and put them in the food supply, neither petitioning the FDA for a GRAS designation or sometimes informing the FDA the additives are being used!
A recent expose by the Natural Resources Defense Council (NRDC) about GRAS in which it refers to the program as “Generally Recognized as Secret,” reveals a don’t ask/don’t tell system in which as many as 1,000 additives have been self-declared “safe” by the companies that make them but not the FDA. In many cases, neither the FDA or consumers know the ingredients are in the food; in other cases, ingredients the FDA has specifically rejected as GRAS still are used in food–sometimes, ironically named on the label.
And it gets worse. Many of the companies making the additives are headquartered overseas like the China-based Hanzhong TRG Biotech and NutraMax. China has a poor consumer safety record say U.S. officials with many imports rejected because of “pesticides, bacteria and filth.” In 2007, tainted pet food from China killed many U.S. dogs and cats.
When additives are imported, it make the GRAS situation “triply difficult” for the FDA, Erik Olsen, senior strategic director for health and food at the Natural Resources Defense Council told me, especially when the companies self-declare them as safe. The FDA does not realize the additive is being used, has not, as an agency, evaluated the additive’s safety and it lacks a mechanism for assessing the safety of imported products. Buyer beware.
Why would additive makers ever petition the FDA for a GRAS determination as opposed to self-declare an ingredient safe in the “honor system” we asked Dr. Olsen. Doesn’t petitioning the FDA just result in a delay and risk an online “rejection letter” if the ingredient doesn’t make it? Yes, he told us, but an FDA determination could help additive makers sell their products to food companies who would likely be liable if an ingredient proved dangerous.
Rules for what proves “safety” are also vague, Dr. Olsen told us. It is largely assumed that if a company self-declares its product “GRAS” and markets it, there exists corroborating scientific or clinical evidence somewhere if the FDA should ever want to see it. But NRDC investigations found that sometimes the proof of safety boils down one paltry published study. Almost none of the companies NRDC contacted would provide information about their GRAS determination–often citing “proprietary” reasons–though several assured NRDC their products were safe and some provided supporting studies. Four companies said they would provide safety information about five additives if NRDC swore to keep it confidential. We’re eating it but it’s a secret?
Who are the additive companies? A quick glance shows a roster of chemical, drug and biotech companies as opposed to well known food corporations–names like Merck eprova AG, located in Switzerland and BASF Cognis Nutrition and Health, part of BASF, the world’s largest chemical company, based in Germany with 66 U.S. subsidiaries. Yum.
What products are their ingredients found in? That is the ultimate question, says Dr. Olsen. The information is not provided by the companies and of course it does not appear on the food labels. After all, it is Generally Recognized as Safe.
Here are some ingredients that may be in your food or beverages without being on the label.
Fo Ti (Shou Wu Pian/ Ho Shou Wu)
Fo Ti made from the tuber of the climbing knotweed (Polygonum multiflorum) has been a popular Asian remedy for cancer, tuberculosis, diabetes, hypertension, infections, erectile dysfunction, infertility, muscle soreness, headache, dizziness, graying of the hair and constipation. It is used as a tonic in liver and kidney conditions and to fortify muscles and bones. But, according to the National Institutes of Health, “a large case series of clinically apparent acute liver injury ha[s] been attributed to use of Shou Wu Pian.” The liver toxicity “resembles acute viral hepatitis with onset of fatigue, nausea and right upper quadrant pain followed by jaundice,” says the NIH and “liver biopsy shows changes typical of acute hepatitis.”
Kava is a plant that grows in the western Pacific. Prized for its mental effects like sedation, relaxation and relief of anxiety, it became a popular supplement in the U.S. for treating anxiety, depression, insomnia, stress and menopausal symptoms. But in 2002, the FDA warned consumers and health care professionals of the potential risk of severe liver injury from kava kava including hepatitis, cirrhosis, and liver failure. In its letter to health care professionals, the FDA noted that Germany and Switzerland took kava kava off the market after “approximately 25 reports of hepatic toxicity associated with the use of products containing kava extracts have been reported in these countries.”
Lobelia is the name for several flowering plants that grow in tropical and warm climates of the world and are used as herbal remedies. The plant was frequently used for respiratory problems in Native American societies and became known as Indian tobacco while it was also called “asthmador” from its use in Appalachian folk medicine. Like tobacco, with which it shares some properties, lobelia is known to cause nausea, vomiting and dizziness. But according to WebMD, that’s just the beginning of it risks. Lobelia is considered “likely unsafe for most people when taken by mouth,” writes the health website. An overdose may cause “serious toxic effects” like convulsions, collapse, coma, and possibly death. GRAS?
Black Cohosh and Other Female Hormones
Because or its high estrogen content, black cohosh is called “possibly unsafe” by WebMD and capable of worsening breast cancer and other hormone-linked conditions like endometriosis, fibroids and ovarian and uterine cancer. There are also reports of black cohosh links to liver damage and rejection of transplanted kidneys. Black cohosh is hardly the only hormonally active additive which NRDC believes are in food products with undisclosed GRAS safety determinations. Chasteberry, astragalus, red clover, milk thistle, ginseng, fenugreek, hops and of course soy and flax also pack a big estrogen wallop. Certainly such herbs are not necessarily safe in people with hormone-fed cancers and they should be on the label.
It was with shock that I discovered hydroxyzine HCL on NRDC’s list of undisclosed GRAS safety determinations and presumably unlabeled in the food supply. It is the same ingredient found in Vistaril and Atarax, two prescription drugs used to treat anxiety, allergies and to control nausea and vomiting! According to Drugs.com, hydroxyzine may impair thinking and reaction time, making driving dangerous. It is also dangerous when used with alcohol. Hydroxyzine may be considered Generally Recognized as Safe by its manufacturer, NutraMax, but it is also related to the popular allergy drug Zyrtec. Infact, the medical site Medicinenet writes, “The active form of hydroxyzine is a drug called cetirizine (Zyrtec).”
Martha Rosenberg is an investigative health reporter. She is the author of Born With A Junk Food Deficiency: How Flaks, Quacks and Hacks Pimp The Public Health (Prometheus).