Friday, April 24, 2015

Antioxidant Claims and FDA Regulation

Memorandum from Ralph Fucetola JD
To: Vitamin Consultancy Contact List:
Keep May 1, 2015 open for an exciting Health Freedom Event: the Mayday! Marathon :
[1] Many vitamin purveyors want to make Antioxidant Claims about their products. Free-radical quenching nutrients are of great significance in achieving and maintaining a healthy status...
So it shouldn't surprise us that FDA has restrictive regulations on using the term "Antioxidant" -- restrictions of which very few in the industry are aware.
Here is the central relevant regulation language [there are other requirements which I can discuss with you if you are interested]:
"(g) Nutrient content claims using the term "antioxidant." A nutrient content claim that characterizes the level of antioxidant nutrients present in a food may be used on the label or in the labeling of that food when: (1) An RDI has been established for each of the nutrients; (2) The nutrients that are the subject of the claim have recognized antioxidant activity; that is, when there exists scientific evidence that, following absorption from the gastrointestinal tract, the substance participates in physiological, biochemical, or cellular processes that inactivate free radicals or prevent free radical-initiated chemical reactions..."
Primarily, the restriction that often causes issues for herbal antioxidants and other nutrients is that they do not have a RDI -- Recommended Daily Intake -- and thus cannot qualify under the Regulation. So what is the work-around?
Since the Vitamin Consultancy is here to make sure you have a way around bureaucratic restrictions, this is my suggestion for an alternative rubric to express your products' antioxidant claims if they do not qualify under the Regulation:
"Supports Normal Antioxidant Function" -- SNAF.
Of course, "the devil is in the details" and I'm here to work with you on those. Valid substantiation is required. Just let me know how I can help.
[2]  If you are on this elist, you are most likely involved in the Natural Products market. And, if so, a number of you have, in addition to dietary supplement products, some cosmetic products.
And... if so... have you considered marketing your natural cosmetic products in the European Union?
There are special rules that easily  let you do just that!
Rima Laibow, MD and Robert Goodman, PhD have teamed-up with me to provide the required third-party EU Cosmetic Dossier services for you.
What is that?
Take a look at the short slide presentation here:
You will be pleasantly surprised.
[3] And remember that my full SOP Training Webinar System is available for your . Does your manunfacturing facility need a Virtual Audit? More about that here: