FDA says certain ‘basic’ claims about health benefits can be made without seeking its approval
PUBLISHED : 3 Jul 2024 at 18:44
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Omega-3 fish oil capsules and a host of related products are popular with consumers seeking to improve their health. (Photo: Jernej Furman via Wikimedia Commons)
The Food and Drug Administration (FDA) has clarified the conditions under which producers of so-called functional food products can make basic health claims on their packaging without seeking the regulator’s approval.
The goal is to improve the prospects for the business of food supplements and related products, estimated to be worth 100 billion baht a year, said Lertchai Lertvut, the deputy secretary-general of the FDA.
Information showing nutritional and health advantages of products helps consumers make informed decisions. The FDA only allows basic health claims that are proven, acceptable and credible, stressed Mr Lertchai.
The message on a product package must align with at least one of three criteria set out in the new regulation, he said.
The first relates to the functions of 28 nutrients. The FDA allows a total of 135 statements in this regard. Examples include “Protein is necessary for body growth and repairing deteriorated parts”; “vitamin C functions as an antioxidant”, and “vitamin B1 helps the body’s cells change carbohydrates into energy”.
The second health claim concerns the functions of six food components, with eight statements permitted for each one. For example: “Beta-glucan from oats and barley helps reduce cholesterol absorption” and “choline improves lipid metabolism”.
Finally, the FDA allows four statements for two ingredients related to the reduced risk of disease. These include the following: “A diet low in sodium may help reduce the risk of high blood pressure, which is a major risk factor for stroke and heart disease”, and “a diet low in saturated fat may help reduce blood cholesterol levels. High blood cholesterol is a risk factor for coronary heart disease”.
The new regulation took effect on Tuesday.
Mr Lertchai said more health claims will be approved in the future, adding that the regulator has been working closely with related agencies on other health claim assessments to promote the functional food industry.
The value of the functional food products business this year will reach about 100 billion baht, up 8% from last year, according to the Office of the National Higher Education, Science, Research and Innovation Policy Council. Functional food product exports are expected to be worth 128 billion baht, up 9%.
“Entrepreneurs can put the approved messages on their products’ labels without requiring additional permission from the FDA,” said Mr Lertchai.
“But if they want to make other health claims that are not stipulated in the regulation, they will need to submit reports to confirm those benefits, which will be approved on a case-by-case basis.”
