This issue was first raised in an advanced notice of proposed rulemaking (ANPRM) from the FDA back in 2007, and prompted a lot of anxiety amongst supplements makers.
An FDA spokesman told NutraIngredients-USA.com: “We are drafting the proposed rule and therefore nothing has been published since the 2007 ANPRM. We hope to publish this year.”
Why does it matter?
If for example, as some stakeholders fear, the FDA proposes that percent daily values for key nutrients are based on EARs (Estimated Average Requirements) instead of RDAs (recommended dietary allowances) – the dosage needed to get 100 percent of your daily value would drop considerably, as EARs are much lower than RDAs.
As a result, some consumers could mistakenly believe they are getting all the nutrients they need from their foods and might no longer deem it necessary to buy dietary supplements, argue trade associations.
Speaking to this publication at Supply Side East earlier this year, Council for Responsible Nutrition (CRN) chief executive Steve Mister said: “Our strong suspicion is that they [FDA] will come up with something we don’t want.”
He added: “Going by the EAR would push down all of the numbers so less healthy foods would seem more healthy. EARs are based on population averages, so while the amounts might be sufficient for half of the population, they won’t be enough for the other half. Using RDAs ensures that 90 percent of the US population gets what they need if they hit them.
“We believe the only logical basis for the daily value is the highest RDA or Adequate Intake (AI) established by the Institute of Medicine.”
Codex July 4 agreement
One the plus side, international standards body Codex had just adopted a guideline on nutrient reference values (equivalent to daily values in the US) specifying that they should be based on INL-98 values (slightly higher than RDAs, which are equivalent to INL-97.7) and the mean of these values for adult men and women.
And this could be important in any US rulemaking on daily values, said CRN International chair Mark LeDoux, speaking to NutraIngredients-USA last week.
“This was adopted by unanimous consent, which is very unusual, so we can only hope that this will impact thinking at the FDA and that they won’t take a step backwards on this.”
He added: “The scientific evidence on vitamin D requirements doesn’t square with the EAR approach at all.”
The CRN also welcomed news that the French Council of State had annulled some of the maximum values for supplements that it enacted in May 2006, notably those for vitamin B12, he said.
“There is still a lot of parochialism when it comes to NRVs and maximum levels, and you still have countries that say one times the RDA is adequate [for a maximum limit] but what’s happening at Codex may have a positive effect on the ASEAN states (The Association of Southeast Asian Nations).”
Widely different standards between different countries were hugely frustrating for firms operating in multiple markets, he said.
“Let’s say you are introducing a vitamin C product to 50 countries, you need 50 different versions in terms of potency [to stay within the law]. This makes it very expensive for companies engaged in global commerce.
“Imagine if you added vitamins to Coke, you would have to have 300 different formulas for all the markets they are in.”
If the global economy started to improve, more effort might be made towards harmonizing rules, he said. But tough economic times had encouraged a more protectionist approach from many countries.
‘Over-nutrified’ or ‘under-nutrified’?
As to why the FDA was considering changing the rules in the first place, CRN’s Mister blamed a powerful lobby that believed the US population was becoming ‘over-nutrified’, although there was little evidence to support this contention, he claimed.
“In fact the reality is the opposite: Americans eat way too many calories but don’t get enough nutrition. The NHANES (National Health and Nutrition Examination Survey) data consistently show that on average, many Americans fail to achieve the recommended intakes for many nutrients.”