GOED aims to file omega-3 cardio health claims petition by year-end
While the Food and Drug Administration (FDA) has already authorized a qualified health claim to this effect, it is of “limited value in the marketplace” according to GOED vice president, regulatory & scientific affairs, Dr Harry Rice.
Qualified claim doesn’t accurately reflect current science
He said: “The claim does not accurately reflect the current state of the science. [So] we are seeking an unqualified health claim which is a claim with significant scientific agreement.
“We plan to submit a petition for an authorized health claim. In the absence of any significant issues that may need to be addressed, we would like to have something submitted by the end of the calendar year. This is a large undertaking and we're only at the beginning. [But] once we get rolling, it should move along at a steady clip.”
He added: “The feedback we have received is that the wordiness of the claim gets in the way of the message, which is inaccurate given the current state of the science. We're looking for something with unconditional language to reflect the current state of the science.”
FDA qualified health claim for omega-3s EPA and DHA
The FDA approved a qualified health claim for omega-3s in supplements in 2000.
It was then petitioned by Life Extension and Wellness Lifestyles to approve a stronger claim stating that ‘consumption of omega-3 fatty acids may reduce the risk of coronary heart disease’ in 2003, but determined that the ‘significant scientific agreement’ standard had not been reached.
A year later, it approved a qualified health claim for omega-3s in conventional foods with the wording:
"Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease. One serving of [name of food] provides [x] grams of EPA and DHA omega-3 fatty acids. [See nutrition information for total fat, saturated fat and cholesterol content.]”
A systematic evaluation of the peer-reviewed literature
However, many stakeholders now believe the evidence behind the cardiovascular benefits of omega-3s is so overwhelming that the ‘significant scientific agreement’ standard has been reached.
GOED has two options, said Rice.
“One: Submit a notification of a health claim based on an authoritative statement of a scientific body. While there is much debate about satisfying the requirements for an authoritative statement, the FDA has been clear that it does not believe there exists a valid authoritative statement from a scientific body about the benefits of EPA & DHA.
“Two: Submit a petition for an authorized health claim. This option requires a systematic evaluation of the peer-reviewed literature.
“[So] we plan to submit a petition for an authorized health claim.”
Qualified health claims
Qualified health claims have been permitted in the US since the 1999 Pearson v. Shalala case (brought against the FDA by attorney Jonathan Emord on behalf of Durk Pearson and Sandy Shaw), which validated them as a First Amendment freedom of speech right.
The claims enable firms to talk about a relationship between a substance and disease where the supporting science fails to meet the FDA’s ‘significant scientific agreement’ standard, but is ‘qualified’ in such a way as to not mislead consumers.
While the qualification comes in the form of a far-from-consumer-friendly disclaimer, many observers believe the claims are still better than nothing.
Health claims meeting significant scientific agreement standard
To date, only a handful of authorized health claims have been approved, including:
- Calcium, Vitamin D, and reduced risk of osteoporosis
- Dietary saturated fat and cholesterol and reduced risk of coronary heart disease
- Dietary non-cariogenic carbohydrate sweeteners and reduced risk of dental caries
- Fiber-containing grain products, fruits and vegetables and reduced risk of cancer
- Folic acid and reduced risk of neural tube defects
- Fruits and vegetables and reduced risk of cancer
- Fruits, vegetables and grain products that contain fiber, particularly soluble fiber, and reduced risk of coronary heart disease
- Soluble fiber from certain foods and reduced risk of coronary heart disease
- Soy protein and reduced risk of coronary heart disease
- Stanols/sterols and reduced risk of coronary heart disease