BPOM released a Circular Letter, dated 30 December 2016, stating that the EPA / DHA content of dietary supplements with general function claims had to be under 300mg a day, and supplements with EPA / DHA content exceeding 300mg a day would necessitate a health claim.
The letter also said such supplements should include warnings for consumers to “be careful when consuming products which contain more ΕΡΑ than DHA in conjunction with anti-coagulants, because they may increase the blood-thinning effect”.
However, BPOM has now declared the letter null and void. This came after the Global Organization for EPA and DHA Omega-3s (GOED), compiled infomation for local trade body Asosiasi Pengusaha Suplemen Kesehatan Indonesia (APSKI) to present to BPOM in February.
In January, GOED’s VP of regulatory Harry Rice told us the rule changes had come as a surprise, and it was unclear what had prompted BPOM to implement the restrictions.
He said: “Before this circular, there was no daily limit for EPA and DHA”, adding that he hoped the issue would be resolved as soon as possible, “not only because of its restriction on the Indonesian market, but because it could have an impact on what other countries decide to do”.
Anti-coagulants concerns
After reviewing the information from GOED, APSKI asserted that BPOM’s “policymaking was inaccurate” and based on scientific data that did not offer “the whole picture”. BPOM has since revised its restrictions, so that supplements containing over 300 mg of EPA / DHA can now be sold without health claims.
Still, BPOM requires health supplements that contain more EPA than DHA to carry a warning about consuming anti-coagulants alongside products high in EPA, as it believes this results in a significant blood-thinning effect.
BPOM also advises those who consume such supplements to consult with their doctors on their intake, especially prior to undergoing any surgery, due to the agency’s belief that patients might bleed excessively.
The two trade bodies will continue to lobby against the exisiting restrictions.