Good fats and vitamins keep the brain young!

By James J. Gormley

“Get rid of all trans fats in your diet!” is the main takeaway message from a December 28 study on vitamins and the brain in the journal Neurology.

According to lead author Gene Bowman ND MPH, an assistant professor of neurology at the NIA-Layton Center for Aging & Alzheimer Research at Oregon Health and Science University in Portland, the study, entitled “Nutrient biomarker patterns, cognitive function, and MRI measures of brain aging,” looked at the relationship between nutrient status, cognitive function and brain health in 104 elderly participants, 62 percent of whom were women.

Utilizing eight distinct nutrient biomarker patterns (NBPs) out of 30 that were originally developed, the authors were able to see, by using psychological and cognitive tests, blood tests and nuclear magnetic resonance imaging (MRI) which participants had less brain shrinkage, or atrophy, and what these nutrient profiles suggest as to what dietary practices may be associated with better cognitive health as we age.

The nutrient biomarker pattern (NBP) was first tested and validated against food frequency questionnaire studies by Bowman and his colleagues in an earlier 2011 study which appeared in the journal, Alzheimer’s Disease & Related Disorders.

“What we’re doing is picking up on the plasma signatures of different nutrient combinations, which will help us come up with better nutritional and public health recommendations,” said Bowman, in a December 29 phone interview.

The results indicated that those who had the highest blood (plasma) levels of vitamins B, C, D and E and omega-3 fats (good fats) did the best on cognitive tests and had the healthiest brains; those who had the most bad fat, specifically trans fat, in their blood did the worst on cognitive tests and had the least healthy brains – meaning their brains showed some initial signs of volume loss, or shrinkage, an early warning for potential dementia or Alzheimer’s disease down the road.

According to Jeffrey Blumberg PhD, director of the Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University in Boston, the results of “the Bowman study are consistent with several of the studies completed by Martha Clare Morris (and her colleague, Christy Tangney).

“They are also consistent with those showing a beneficial relationship of B vitamins (especially B12) and brain volume published a couple years ago (from a British group). Similarly, observational studies have shown an inverse correlation between folate [folic acid] intake/status and risk for age-related dementias. The Physicians Health Study found beta-carotene is associated with less cognitive decline in aging. And some (but not all) studies have found a benefit of vitamin E supplementation on cognitive performance and/or rate of decline in Alzheimer’s disease.”

It is known that trans fats, which are found in deep-fried foods and as partially hydrogenated oils found in packaged snack and other processed foods, are bad. This study, however, is “the first study to look at trans fats in the context of brain health and functioning,’ added Bowman.

This study, said Bowman, was funded by the U.S. National Center for Complementary and Alternative Medicine (NCCAM). A future study, one that is in the works, will look at the impact of diet on cognition in people over many years or even decades, which is called a longitudinal study.

“Is all that frozen pizza really worth it?,” asked Bowman, who suggests, on the positive side, that people should consider eating more “fish, beans, citrus fruits [and] dark green leafy vegetables.”

Gormley Files Take-Away: Is pizza bad? No, it can be pretty healthy, and frozen pizza at your local health-food store is probably very healthy! But the takeaway here is the very real science that shows that diets drenched in nasty, oxidized trans fats and saturated fats, and low in nutrients makes the brain atrophy, or shrink. Diets rich in omega-3 fats, B vitamins and antioxidants (and low in the bad stuff) keep the old neuroprocessor between our ears healthy and peppy!

‘Supplements Are Safe, Healthful and Well-Regulated’!

By James J. Gormley

On March 25th, 1999, I was part of a live television debate on FOX-TV’s “Good Day New York” with a drug industry attorney on the topic: “Are dietary supplements regulated?”(1)

Needless to say, with all of the facts showing how well regulated dietary supplements were then, winning the debate was not a difficult accomplishment; I even had the host, Jim Ryan, on the side of supplement consumers about midway through the segment.

In fact, the regulations and laws governing nutritional supplements in 2011 are even more stringent than they were in 1999, when I did that show.

According to attorney Peter Barton Hutt, the “bedrock food safety requirement that has been the foundation of the American food supply since 1906 — the prohibition of poisonous or deleterious substances in food—applies equally to dietary supplements and conventional food” (2).

Supplements: A Super-Regulated Category
Today, dietary supplements have the following requirements and controls over them:

• Pre-market notification to the U.S. Food and Drug Administration (FDA)—not required for drugs or medical devices.
• Labeling.
• Mandatory adverse event (side effect or reaction) reporting to the FDA (not required for foods).
• FDA Good Manufacturing Practices (GMPs).
• Facility registration (for the FDA).
• Advertising (by the U.S. Federal Trade Commission).

In fact, broadly speaking, the laws governing supplements under the umbrella of the Food Drug and Cosmetic Act (FD and C) are: the Nutrition Labeling and Education Act of 1990 (NLEA); the Dietary Supplement Health and Education Act of 1994 (DSHEA); the Bioterrorism Act of 2002; the Food Allergen Labeling an Consumer Protection Act of 2004; the Dietary Supplement and Non-Prescription Drug Consumer Protection Act of 2006 (AER Law); and Federal GMPs.

Regarding dietary supplements, the FDA has significant powers, including (but not limited to) the authority to:

• Stop a company from selling any dietary supplement that is unsanitary or unsafe.
• Stop the sale of any dietary supplement that makes false or non-substantiated claims on its labeling.
• Stop the sale of any nutritional supplement that poses “a significant or unreasonable risk of illness or injury.”
• Block a new dietary ingredient (NDI) from being marketed if the agency does not receive enough safety information in advance.

Likewise, the FTC has a great deal of surveillance and enforcement powers that it uses for dietary supplements, including the ability to: challenge and stop advertising that is not sufficiently substantiated; negotiate a consent order for a company to change or fix its promotional, marketing or advertising practices; and to seek substantial civil penalties for violations of trade regulation rules or violations of cease and desist orders. 

So Why Do We Keep Hearing About Supplements Being Unregulated?
Part of the problem is the media.
As I noted way back in 1999 (1), despite powerful and authoritative research underpinning many of the most popular supplements today, the mainstream media appear to be on a planet where this research is unavailable or incomprehensible.

The FDA itself has also been stoking the misinformation fires about the supplement regulations that it is mandated to implement and enforce. As I noted in July 2009, “The FDA should cooperate with the responsible core of the natural products industry rather than criticizing the very laws that the American people saw fit to pass and which the FDA is sworn to uphold and enforce” (3).

Dietary supplements have “always been regulated as a category of food in this country, and DSHEA did not change that,” according to the Council for Responsible Nutrition (CRN) (4).

“Dietary supplements are not regulated as drugs because they are not drugs,” added Jeffrey Blumberg, PhD, FACN, director of the Antioxidants Research Laboratory at the Jean Mayer USDA Human Nutrition Research Center on Aging, at Tufts University (3).

According to Hutt, it is “apparent that FDA has adequate statutory authority to assure the safety of both dietary ingredients and conventional food ingredients” (2).

In fact, Hutt adds that the “safety provisions under the FD and C Act applicable to dietary supplements would appear to be stronger than those applicable to conventional food.”

‘Supplements Are Safe, Healthful and Well-Regulated’ may not be a very “sexy” story title as they go, but it is one that really should be front-page news.

Gormley Take-Away: Given all of the recent drug recalls and food contamination outbreaks, I would be much more concerned about the safety of pharmaceuticals and conventional foods than about dietary supplements if I were the average consumer advocate, legislator or reporter. Looking at the powerful safety record of dietary supplements, now officially demonstrated via the AER Law, I would consider beating a different drum than the one associated with unwarranted and uninformed attacks on supplements.

REFERENCES
1. Gormley J. Mass media is unregulated [Editor’s Desk]. Better Nutrition. August 1999.
2. Hutt PB. FDA Statutory Authority to Regulate The Safety of Dietary Supplements [White Paper]. Covington and Burling, June 6, 2003.
3. Gormley J. Making the ‘cut’: What the latest recall tells us … and doesn’t. The Gormley Files. July 21, 2009.
4. Council for Responsible Nutrition. Dietary supplements: Safe, beneficial and regulated. Revised December 2009. Accessible at: http://www.crnusa.org/CRNRegQandA.html

Making the “Cut”: What the Latest Recall Tells us … and Doesn’t

By James J. Gormley

So we’ve all read the headlines about the recent recall of a line of 14 dietary supplements due to 23 reports of serious adverse events linked to (but not proved to caused by) the weight-loss and bodybuilding products in question.

The product recall that was requested by the U.S. Food and Drug Administration has been applauded by the natural products industry, as it shows how effective are the Dietary Supplement Health and Education Act of 1994 (DSHEA) and the AER Law.

If truth be told, the manufacturer should have known better, regardless of where the final toxicology reports or class action lawsuits wind up, since a number of the recalled products were made with a modern version of the dangerous old “ECA stack” formula (ephedra-caffeine-aspirin, or ECA), with each serving containing stimulant herbs, over 400 mg of caffeine plus willow bark extract (natural aspirin).

That being said, the FDA, long believed to be a foe of the dietary supplements industry, is taking advantage of the recall to repeat its oft-voiced complaint that its hands are largely tied because it must rely on voluntary reports and post-market monitoring. “Part of the problem is that the FDA looks at dietary supplements from a post-market perspective and an isolated incident is often difficult to follow,” said the FDA’s Linda Katz, M.D., M.P.H.

Katz and the mainstream media are missing the point.

Dietary supplements, because they are a class of food products, are considered largely safe. Food products, and products derived from foods and plants, are presumed to be benign and have very little, often no known, side effects.

The ingredients in supplements are mainly natural ingredients that have co-evolved with humans from time immemorial and especially since the creation of agriculture 10,000 years ago.
They form what ethnobotanist Dr. Jim Duke refers to as the “Green Pharmacy” of healing and healthful compounds. When not used properly or used by profoundly unhealthy, often heavily medicated consumers looking for a quick fix, they are linked to a few hundred adverse event reports each year.

Drugs are largely synthetic, powerful chemical compounds that are not found in the food supply and which are presumed to be dangerous and often have very serious, known side effects.
Drug chemicals are primarily artificial compounds synthesized to dramatically change, stop, block or boost a system or process in the body in order to improve symptoms. They cause over 100,000 deaths a year and close to 1 million serious adverse events.

“Dietary supplements are not regulated as drugs because they are not drugs,” adds Jeffrey Blumberg, PhD, FACN, director of the Antioxidants Research Laboratory at the Jean Mayer USDA Human Nutrition Research Center on Aging, at Tufts University.

According to David Seckman of the Natural Products Association (NPA), “This prompt action shows that the current DSHEA [law] works and that the adverse event reporting (AER) law that we helped to pass is working to enable the agencies to detect signals of any threat to public health. Thus, the industry is more than appropriately regulated and necessary consumer protections are in place.”

“They are regulated in exactly the same manner as all food and beverage products, including review of labeling claims, [post-market] surveillance, adverse event reporting, and so forth” agreed Blumberg. “The research base regarding most essential nutrients is more extensive than that of most drugs.”

Gormley Take-Away: DSHEA and the AER Law work very well. The FDA should cooperate with the responsible core of the natural products industry rather than criticizing the very laws that the American people saw fit to pass and which the FDA is sworn to uphold and enforce. While consumers should not be scared about this rare product recall, some manufacturers (and these few companies know who they are) should take a hard look at their products and their safety and testing data to make sure they are not repeating mistakes of the past relating to formulas and claims, because nobody benefits from inadequate vigilance, the companies included.