Omega-3 clampdown in Indonesia: Regulator now given ‘full picture’ says national trade body
According to Asosiasi Pengusaha Suplemen Kesehatan Indonesia (APSKI), the decision to only allow DHA and EPA health claims for items under 300mg was based on inaccurate evidence.
“We saw the policy-making was inaccurate, the scientific data that they potentially read upon or made a decision upon, may not have been the whole picture on Omega-3,” Patrick Kalona, chairman of APSKI, said.
“[The] government sometimes take data from other journals or countries that limit the use of certain ingredients. In the case of Omega-3 circular, there was a lot of scientific research that verified that it [300 mg limit] was inaccurate, so that’s where we came in present to our government other verified data on omega-3 intake.”
APSKI has already presented its case. Kalona said it was still awaiting further notice from BPOM, the Indonesian national agency of drug and food control, on a final hearing about this issue.
Global omega-3 trade body GOED also compiled information to submit to BPOM for its review.
The organisation's VP of Regulatory Harry Rice told us in January it was not clear what provoked BPOM’s reaction and that there was no indication the change was on the cards.
“As far as we know, before this circular, there was no daily limit for EPA and DHA. Even when BPOM talked about putting certain restrictions on the sale of omega-3 rich oils a number of years ago, there was no daily limit discussed.
“Members are eager to see this issue resolved, not only because of its restriction on the Indonesian market, but because it could have an impact on what other countries decide to do,” he added.
Engaging the regulator
Back in Indonesia, Kalona said APSKI would continue to challenge BPOM where needed and vowed to act as a strong ‘sparring partner’ for the regulator.
“I think all trade organisations to a certain degree obviously fight for the interests of industry,” said Kalona.
“Fight is probably a strong word, it is also recognised that we are a good partner for our regulator. More likely we would want to be recognised as a strong sparring partner.”
Kalona said one of APSKI’s key role was to “enlighten” the regulator on other perspectives concerning a specific ingredient or its use.
“Sometimes their perspective on the industry is different, but that’s where we come in and it is our job to enlighten them,” he said.
“We have a scientific committee made up of scientists or industry practitioners – PhDs, researchers, who have the highest access to research and data.
“This team help us communicate a clear, concise and scientific approach to policies or issues that may hinder or may not be accurate for the industry.”
Kalona stressed that companies in manufacturing or product development needed to work closely with regulators, for the benefit of consumers.
“You can be the greatest scientist in the world, with all the studies and papers, but in the end, if your ingredient is not allowed in the product, it is not allowed in the product,” he said.
“That’s why we focus so much on regulation. As compliant companies, and good citizens of any country, you would want to comply."
