It could be several months before a qualified health claims petition about vitamin D is submitted to the Food and Drug Administration (FDA), according to the lawyer coordinating the application.
Jonathan Emord from Virginia-based legal firm Emord & Associates was updating NutraIngredients-USA following an announcement from the Alliance for Natural Health (ANH) USA in January that it was preparing a petition.
However, there was no guarantee that this would ultimately be filed, while it was also too early to say which diseases (eg. certain cancers?) might be the focus of the submission, stressed Emord, who is assisting the ANH-USA.
He added: “We are likely months away [from filing a petition], if at all, because once the science is reviewed, the scientists will opine on the strength of the evidence. Only if it is sufficiently strong will the client elect to file a petition. The vetting process is lengthy, detailed, and rigorous.
“There are over 6,000 peer-reviewed journal articles on the relationship between Vitamin D and cancer, not to mention those concerning other nutrient disease relationships."
ANH-USA: IOM recommendations on vitamin D ‘ridiculously low’
A debate over just how much vitamin D we need – and the health benefits that might follow – has been raging for years, but has recently stepped up a gear following a controversial report by the Institute of Medicine (IOM) published in the New England Journal of Medicine (NEJM).
Evidence suggesting a link between vitamin D intakes and bone health was sound, concluded the IOM, which recommended an increase in the RDA to 600 IU/day (a figure the ANH-USA argues is “ridiculously low”).
However, evidence linking vitamin D with a reduced risk of cancer, cardiovascular disease, diabetes and autoimmune disorders was “inconsistent and inconclusive as to causality”, it claimed.
Its conclusions were immediately questioned by several high profile vitamin D researchers including Michael Holick, professor of Medicine at Boston University Medical Center, who said: “If you believe the current recommendations, you will be vitamin D insufficient.”
Qualified health claims
Qualified health claims have been permitted in the US since the 1999 Pearson v. Shalala case (brought against the FDA by 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.
Disclaimers and wording
The most recent qualified health claim to gain FDA approval relates to Gerber's Good Start infant formulas and includes the following disclaimer:
"FDA has concluded that the relationship between 100 percent whey protein partially hydrolyzed infant formulas and the reduced risk of atopic dermatitis is uncertain, because there is little scientific evidence for the relationship."
While Emord argued that this was not a winning statement to emblazon on pack, Natural Products Association scientific and regulatory affairs chief Cara Welch told this publication that it was an “excellent example of using extensive scientific research to your benefit".
Currently, the only FDA-approved health claims about vitamin D are connected to bone health:
- 'Adequate calcium and vitamin D throughout life, as part of a well-balanced diet, may reduce the risk of osteoporosis.'
- 'Adequate calcium and vitamin D as part of a healthful diet, along with physical activity, may reduce the risk of osteoporosis in later life.'