The US Food and Drug Administration (FDA) regulates the labeling and sale of medical devices, nutritional supplements and drugs that claim to improve human health or treat human illness. Omega-3 is a fatty acid that naturally appears in oily fishes and has been shown to improve cardiovascular health. The FDA places restrictions on omega-3 health claims and the manufacturing of this nutritional supplement.
The FDA does not regulate omega-3 dosages, and the manufacturer is responsible for determining that the serving sizes recommended are safe for the public. FDA approval is not needed to sell any dietary supplements containing omega-3, provided these ingredients were approved for use before 1994. With an omega-3 supplement the FDA requires all ingredients in the capsules to be listed on a product label. These include capsule additives such as gelatins and starch, as well as preservatives and dyes. The Current Good Manufacturing Practices (CGMPs) are rules established by the FDA to ensure the purity, quality, and strength of an omega-3 supplement. FDA inspectors may inspect a facility to make sure that these guidelines are met.
The FDA requires any claim about a nutritional supplement to be proven through clinical research. Omega-3 product manufacturers may use customer testimonials, but they may not make any direct claims about their product unless these statements go through the FDA approval process. Manufacturers are responsible for verifying any claims. Omega-3 producers may use general statements such as “omega-3 is found in fish”, when labeling their product.
On September 8, 2004, Dr. Lester M. Crawford, the acting FDA Commissioner, released a statement stipulating that omega-3 manufacturers are now permitted to claim the health benefits of omega-3 fatty acids on product labeling. The FDA allows all omega-3 fatty acid supplements to claim that supportive but not conclusive evidence shows that supplements containing EPA and DHA omega-3 fatty acids can reduce the incidence of coronary heart disease. Omega-3 manufacturers must compare how much fish would provide the same serving as one serving of their omega-3 product.
Lovaza (omega-3-acid ethyl estars) is the only prescription omega-3 product to be approved by the FDA. Lovaza can be used along with diet to lower triglycerides, a common form of fat throughout the human body. Triglycerides can build up in the arteries, causing an increased risk of coronary disease. Lovaza is not allowed to claim that it reduces the risk of heart attacks or stroke. This omega-3 compound has gone through the complete FDA 5-step process, but the product’s health claims are limited.