Wednesday, March 03, 2010

In Defense of Natural Foods: Fish Oils

In Defense of Natural Foods

By Neil E. Levin, CCN, DANLA

A public debate is now raging over the safety of natural fish oils. In truth, though, this should be more properly recognized as a narrowly focused legal debate rather than representing any real question as to whether these natural food products are good for us to eat; because health authorities around the world have already acknowledged that it is generally better to eat natural fish and fish oils than to avoid them. Yet a quirk in California law makes it possible for some environmental lawyers to argue that the general scientific and medical consensus on the known health benefits of natural fish products be ignored; instead touting zero tolerance for pollutants that are widespread in our food supply and advocating that only highly processed oils be sold.

I am certainly not in favor of pollutants; my bona fides are clear. As a student I led environmental classes in my school on the first Earth Day on April 22, 1970 and have broken whole grain bread with the late Earth Day founder Senator Gaylord Nelson at a natural food Thanksgiving dinner. I spent a day with Al Gore at a solar symposium that he hosted in Tennessee in the late 1970’s. My wife and I live on a 4-acre wooded hillside that is a National Wildlife Federation Certified Wildlife Habitat™. We have recycled, grown and bought organic food, used primarily natural and biodegradable products in our home, politically and financially supported several environmental groups, and otherwise have been ardent environmentalists for some 40 years. I’ve worked in the natural food industry for my entire adult life and am so into it that I became a clinical nutritionist who reads complex nutrition studies for kicks. So when I question other environmentalists for creating a public panic that may turn people off from eating foods that provide scientifically demonstrated health benefits despite the possibility of tiny amounts of pollutants being in them, it may merit some attention.

The attorneys argue that only highly processed fish oils are acceptable; all other fish oil products should have label warnings that they may contain parts-per-billion (ppb) amounts of PCBs, a banned industrial chemical that is still so widespread in the environment that the native people of the far north have it in their bodies from the wild fish that is the base of their traditional diet.

According to the Food and Drug Administration (FDA), “Small amounts of PCBs can be found in almost all outdoor and indoor air, soil, sediments, surface water, and animals. However, PCB levels have generally decreased since PCB production stopped in 1977. People are exposed to PCBs primarily from contaminated food and breathing contaminated air. The major dietary sources of PCBs are fish (especially sportfish that were caught in contaminated lakes or rivers), meat, and dairy products.”

What are the health impacts of PCBs? That is really hard to say. Most negative reports are from rodent studies, where the animals are fed huge amounts for long periods. The FDA reports that, “PCBs are not known to cause birth defects,” and has no cases on record, so that concern seems unfounded, despite the claims of the current private lawsuit. The agency does report that PCBs are probable carcinogens based on such animal studies and cases of industrial workers exposed to substantial amounts of the chemicals. It also reports developmental problems in children of mothers exposed to “high” amounts, but not specifically birth defects and not at significantly harmful levels. “Some studies have estimated that an infant who is breast fed for 6 months may accumulate in this period 6–12% of the total PCBs that will accumulate during its lifetime. However, in most cases, the benefits of breast-feeding outweigh any risks from exposure to PCBs in mother’s milk.”

Fortunately, the FDA has also estimated that the amount of PCBs in food is steadily declining since the chemicals were banned. Between 1978 and 1991, the estimated daily intake of PCBs in adults from dietary sources declined by about 62%. “Meat and dairy products are other important sources of PCBs in food, with PCB levels in meat and dairy products usually ranging from less than 1 part in a billion parts (ppb) of food to a few ppb.” That means a Quarter Pound burger weighing about 113 grams could lawfully contain hundreds of nanograms (billionths of a gram, or parts-per-billion) of PCBs, approaching about half a microgram (a microgram is one-millionth of a gram, or one part-per-million). If you got somewhat less from a natural fish oil, plus enjoyed the added cardiovascular benefits of the essential Omega-3 fatty acids it provides versus the known cardiovascular risks of beef and other animal fats, should that really be a great concern, especially when heart disease is blamed for about half the deaths in this country?

The official Health Canada federal agency reports that, “Exposure to these low levels does not appear to affect human health. Based on recent results from Total Diet Studies (a series of studies organized by Health Canada), the average daily dietary intake of PCBs is thought to be less than half of one microgram (one microgram = one-millionth of a gram). People who eat large amounts of sports fish, wildlife or marine mammals may be exposed to higher dietary levels of PCBs…Media reports have raised concerns about PCBs in farmed salmon. Health Canada and the Canadian Food Inspection Agency recently completed a survey of farmed and wild fish. The survey analyzed a large number of samples for PCBs. The results showed that eating salmon from the commercial food supply (whether farmed or wild) does not pose a health risk to consumers.”

The UK Food Standards Agency has reported that the health benefits of eating moderate amounts of fish, including salmon, as part of a healthy balanced diet outweighed any potential risk from PCBs. Based on 21 surveys carried out by the Agency results found that exposure to these contaminants from the diet has fallen by about 75% between 1982 and 1997.

How has the U.S. federal government determined safe levels of PCBs in foods? “The FDA has set residue limits for PCBs in various foods to protect from harmful health effects. FDA required limits include 0.2 parts of PCBs per million parts (ppm) in infant and junior foods, 0.3 ppm in eggs, 1.5 ppm in milk and other dairy products (fat basis), 2 ppm in fish and shellfish (edible portions), and 3 ppm in poultry and red meat (fat basis).” Two ppm in fish is equivalent to 2,000 ppb (parts-per-billion) in fish. The fish oil products in question today contain less as a percentage by weight than is allowed even in baby food, and are taken in far smaller amounts by total weight per serving than whole fish. Yet these fish oils are now being targeted for added label warnings that they are known by the state of California to contain toxins with the false implication that these minute dietary amounts are proved to be harmful and should be avoided at all costs.

What are the alternatives? Apparently eating actual fish won’t do; they would be consumed at far larger serving weights and naturally contain far more PCBs than a serving of natural fish oil. Yes, some fish oils are highly purified, which is what the lawyers argue as a reasonable alternative to the natural oils. Yet there are legitimate critics who argue against chemically processing and refining natural food products such as this, even for reasons of purity. And some of the oils most likely to have accumulated PCBs are from long-lived fish which are higher in the ocean food chain and have been long valued as health foods with strong evidence of enhancing human health, like cod liver and salmon oils.

If we force all foods to either have disproportionally scary warnings or be processed out of their natural states, pushing only the least natural products as the “best” choices, this has serious implications for the nature of our food supply and how it impacts our nutritional status. We have seen degenerative disease rates soar as the amount of refined foods in the diet increases, and natural food advocates have long argued that we return to unrefined whole foods in order to naturally maintain health. This current fish oil scare is capable of needlessly frightening people away from taking safe healthy fish oils that could improve their health. That would be the real crime.


Agency for Toxic Substances and Disease Registry (ATSDR). 2000. Toxicological profile for Polychlorinated Biphenyls (PCBs). Atlanta, GA: U.S. Department of Health and Human Services, Public Health Service.

Health Canada

The UK Food Standards Agency

Tuesday, March 02, 2010

Vitamins Are FDA-Regulated

Contrary to popular myth and The Healthy Skeptic (LA Times 3/1/10), the federal FDA (Food and Drug Administration) already regulates dietary supplements such as vitamins, minerals and herbs. These are NOT “unregulated” products. What actually makes critics’ teeth grind is the fact that vitamin formulas do not need specific pre-approval from the federal regulators, which is the true endgame of many skeptics. But all ingredients used in nutritional supplements before mid-October of 1994 are already pre-approved by the FDA under an often-misrepresented law called DSHEA, which also requires all new dietary ingredients to be submitted to the FDA for pre-market review before a product is sold. This gives the agency a chance to review the required submission of safety and efficacy data before any new ingredient can be sold, and the power to veto its introduction.

Dietary supplement manufacturers are already required to submit label claims along with scientific documentation to the FDA, but are paradoxically required to use a label disclaimer that the agency has not evaluated the formula. Vitamin makers are already registered with the government, are already prohibited from making medical/drug claims for dietary supplements, and are already required to identity-test and list all ingredients on product labels. A recent adverse event reporting law promptly lets the FDA know of virtually any problem requiring medical attention in order to trigger recalls and new label warnings. Under DSHEA, the FDA can regulate the manufacture of all dietary supplements, an oversight that was dramatically improved over the past 3 years with the rollout of mandatory Good Manufacturing Practices. Obviously, this is not an “unregulated” industry, even if enforcement can be improved in some areas.

Advocates of pre-approval of dietary supplement formulas want to import a highly flawed and controversial Canadian health care program in a misguided effort to give our own unelected government bureaucrats absolute power over already-regulated vitamin products. Many Canadians now cross the border to buy American supplements because their own government arbitrarily delays entry of new products for years at a time, miserly approving only 42% of products that have been submitted with all of the required safety and efficacy documentation. This is not a free market model, does not work well, and is not worth copying.

A permanent government takeover will strangle a preventive health industry that, in America’s free market, has added jobs and exports during our recent recession. Vitamins help Americans meet basic nutritional needs in a cost-effective manner without government funding; and probably decreased some Medicare spending, according to the conclusions of authoritative Lewin Group reports. There is a complex regulatory structure for vitamins and other dietary supplements in the U.S. that is working quite well; there were ZERO deaths officially reported from these products last year even though about 2/3 of Americans use them. Claims that “vitamins are unregulated” are woefully inaccurate and should not be published by news outlets with competent fact checkers.,0,2486837.story