Omega 3 Fatty Acids and the FDA
In March 1982, Carlson Laboratories introduced the first Fish Oil soft gel (Salmon Oil) to North America based on reputable scientific studies on the benefits of a fish diet.
In June 1988, the FDA objected to our Salmon Oil product based on our promotional materials. The FDA complained that "Promotional material distributed with your products states or suggests that fish oils and salmon oil are useful in the prevention or treatment of heart disease..." Note - they use the world "suggest". Twelve years passed after studies by researchers let doctors to continually recommend fish oils for coronary health.
Then, in November 2000, the FDA, after much pressure from the scientific community, finally allowed the use of a long written qualified claim for fish, which read "...omega-3 fatty acids may reduce the risk of coronary heart disease is suggestive, but not conclusive." Followed on September 8, 2004, by a new FDA qualified health claim for reduced risk of coronary heart disease (CHD) on foods that contain EPA and DHA omega 3 fatty acids. The FDA acting commissioner stated "Coronary heart disease is a significant health problem that causes 500,000 deaths annually in the United States."
The new qualified health claim reads... "supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease" and it also requests the listing of EPA and DHA content of the food or food supplement.
In the past 22 years, the FDA has come a long way, but would any of the 22 X 500,000 people lived a little longer if the FDA had moved a little faster?