Webinar: CRN, VIRGO to bridge GMP gap between industry action and FDA expectations
WASHINGTON — The Council for Responsible Nutrition and VIRGO on Tuesday announced details for an industrywide webinar to examine key elements of good manufacturing practices for dietary supplements and offer advice as to what the industry can do to improve its record of inspections.
Moderated by Duffy MacKay, CRN VP scientific and regulatory affairs, the webinar will help companies better understand the intricacies of GMPs and will offer tips and best practices for passing Food and Drug Administration inspections.
In addition to MacKay, the panel will include as-yet-not-announced Food and Drug Administration representatives and other regulatory experts, such as Joy Joseph, president of Joys Quality Management Systems, and Nicki Jacobs, president of Jacobs Compliance Services. These experts will review several key GMP requirements where inspections have demonstrated patterns of deficiency, such as the requirements to establish specifications for raw ingredients, test incoming ingredients, verify contents of finished products and follow master manufacturing. In addition, speakers will touch upon other often overlooked GMP provisions, such as the “umbrella” clauses that are requirements that apply to all the points on the supply chain, including manufacturers, suppliers, transporters and distributors.
“In the three-and-a-half years since the current GMP final rule first went into effect, there has been a disconnect between what companies are doing and what the FDA expects," MacKay said. "The problems are not limited to one size or type of company but have been seen across the board and are, quite frankly, disturbing. Ultimately, unless the industry improves its track record, our industry’s credibility will suffer.”
The webinar will be held Jan. 18.
Study: High blood pressure in middle age fair predictor of heart attack, stroke
CHICAGO — A hike in blood pressure during middle age significantly raises the risk of having a heart attack or a stroke, according to new Northwestern Medicine research released Monday. The study offers a new understanding on the importance of maintaining low blood pressure early in middle age to prevent heart disease later in life.
Men and women who developed high blood pressure in middle age or who started out with high blood pressure had an estimated 30% increased risk of having a heart attack or stroke compared to those who kept their blood pressure low. Previous estimates of a person’s risk of cardiovascular disease were based on a single blood pressure measurement. The higher the blood pressure reading, the greater the risk. The new Northwestern Medicine study expanded on that by showing a more accurate predictor is a change in blood pressure from age 41 to 55 years.
"We found the longer we can prevent hypertension or postpone it, the lower the risk for cardiovascular disease," stated lead author Norrina Allen, assistant professor of preventive medicine at Northwestern University Feinberg School of Medicine. "Even for people with normal blood pressure, we want to make sure they keep it at that level, and it doesn’t start increasing over time."
"There hasn’t been as much of a focus on keeping it low when people are in their 40s and 50s," Allen added. "That’s before a lot of people start focusing on cardiovascular disease risk factors. We’ve shown it’s vital to start early."
People that maintain or reduce their blood pressure to normal levels by the age of 55 years have the lowest lifetime risk for a heart attack or a stroke.
The study used data from 61,585 participants in the Cardiovascular Lifetime Risk Pooling Project. Starting with baseline blood pressure readings at age 41, researchers measured blood pressure again at age 55, then followed the patients until the occurrence of a first heart attack or stroke, death or age 95.
Men who developed high blood pressure in middle age or who started out with high blood pressure had a 70% risk of having a heart attack or stroke compared to a 41% risk for men who maintained low blood pressure or whose blood pressure decreased during the time period. Women who developed high blood pressure had almost a 50% risk of a heart attack or stroke compared to a 22% risk for those who kept their blood pressure low or saw a decrease.
Men generally have a 55% risk of cardiovascular disease in their lifetimes; women have a 40% risk.
The study is published in Circulation: Journal of the American Heart Association.
Research: Vitamin E helps repair cell membranes
AUGUSTA, Ga. — According to new research released Tuesday, Georgia Health Sciences University researchers have identified one of the internal bodily functions of vitamin E: The antioxidant found in most foods helps repair tears in the plasma membranes that protect cells from outside forces and screen what enters and exits.
"Without any special effort, we consume vitamin E every day and we don’t even know what it does in our bodies," stated Paul McNeil, GHSU cell biologist and the study’s corresponding author. Century-old animal studies linked vitamin E deficiency to muscle problems, but how that happens remained a mystery until now, McNeil said. His understanding that a lack of membrane repair caused muscle wasting and death prompted McNeil to look at vitamin E.
Such everyday activities as eating and exercise can tear the plasma membrane, and the new research shows that vitamin E is essential to repair. Without repair of muscle cells, muscles eventually waste away and die in a process similar to what occurs in muscular dystrophy. Muscle weakness also is a common complaint in diabetes, another condition associated with inadequate plasma membrane repair.
Vitamin E appears to aid repair in several ways. As an antioxidant, it helps eliminate destructive byproducts from the body’s use of oxygen that impede repair. Because it’s lipid-soluble, vitamin E can actually insert itself into the membrane to prevent free radicals from attacking. It also can help keep phospholipids, a major membrane component, compliant so they can better repair after a tear.
For example, exercise causes the cell powerhouse, the mitochondria, to burn significantly more oxygen than usual. "As an unavoidable consequence, you produce reactive oxygen species," McNeil said. The physical force of exercise tears the membrane. Vitamin E enables adequate plasma membrane repair despite the oxidant challenge and keeps the situation in check.
When he mimicked what happens with exercise by using hydrogen peroxide to produce free radicals, he found that tears in skeletal muscle cells would not heal unless pretreated with vitamin E.
The research was reported in the journal Nature Communications.
Next steps, which will be aided by two recent National Institutes of Health grants, include examining membrane repair in vitamin E-deficient animals.