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FDA’s New Guidelines Empower Functional Food Industry to Make Valid Health Claims

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Omega-3 fish oil capsules and a whole array of similar health-boosting products have become staples for consumers keen on boosting their overall well-being. (Photo: Jernej Furman via Wikimedia Commons)

The Food and Drug Administration (FDA) has recently provided clear guidelines regarding the conditions under which producers of so-called functional food products can make basic health claims on their packaging without necessitating prior approval from the regulator. This move aims to enhance the prospects for the thriving food supplements and related products sector, which is estimated to be a 100-billion-baht-a-year industry, according to Lertchai Lertvut, the deputy secretary-general of the FDA.

Presenting accurate and factual information about the nutritional and health benefits of products empowers consumers to make well-informed choices. The FDA permits only those health claims that are substantiated, credible, and validated, underscoring Mr. Lertchai.

The messaging on a product’s package must comply with at least one of the three predefined criteria laid out in the new regulation. The first criterion revolves around the functionalities of 28 nutrients, for which the FDA permits a total of 135 specific statements. These statements include assertions like “Protein is necessary for body growth and repairing deteriorated parts,” “Vitamin C functions as an antioxidant,” and “Vitamin B1 helps the body’s cells transform carbohydrates into energy.”

The second set of permissible health claims addresses the roles of six specific food components, with eight statements allowed for each. Examples include: “Beta-glucan from oats and barley helps reduce cholesterol absorption,” and “Choline enhances lipid metabolism.”

Lastly, the FDA approves four statements related to two ingredients concerning the reduced risk of diseases. These statements read: “A diet low in sodium may help minimize the risk of high blood pressure, which is a significant risk factor for stroke and heart disease,” and “A diet low in saturated fat may contribute to lowering blood cholesterol levels. High blood cholesterol is a risk factor for coronary heart disease.”

This new regulation took effect starting Tuesday.

Mr. Lertchai mentioned that more health claims are likely to gain approval in the future. He pointed out that the regulator is actively collaborating with relevant agencies on other health claim assessments to foster the functional food industry further.

The Office of the National Higher Education, Science, Research and Innovation Policy Council projects that the business value of functional food products will hit about 100 billion baht this year, reflecting an 8% increase from last year. Additionally, functional food product exports are expected to reach 128 billion baht, marking a 9% growth.

“Entrepreneurs can incorporate the approved messages on their product labels without the need for extra permission from the FDA,” stated Mr. Lertchai.

“However, if entrepreneurs wish to make health claims that fall outside of the stipulated regulation, they must submit reports substantiating those benefits, which will then be approved on a case-by-case basis.”

39 Comments

  1. John July 3, 2024

    This is a great move by the FDA! Now we can have more trustworthy health claims on packaging.

    • Skeptic32 July 3, 2024

      Trustworthy? Seriously? These companies are just finding loopholes to fool consumers.

      • John July 3, 2024

        But that’s why the FDA is setting strict criteria! It’s not like they can say anything they want.

      • Jessica R July 3, 2024

        I agree with John. These guidelines make it safer for us to trust the labels.

    • Mary Lee July 3, 2024

      Well, at least some of the claims have to be scientifically proven now. That’s a step forward.

  2. Dave Thompson July 3, 2024

    This can only mean one thing—more marketing hype. Can’t we just eat real food?

    • HealthyMom July 3, 2024

      Real food is ideal, but not everyone has time to prepare balanced meals every day.

    • Grower134 July 3, 2024

      Omega-3 capsules are more convenient than eating fish every day.

  3. Mark July 3, 2024

    I wonder if this will drive up the cost of these functional foods. Consumers will end up paying more.

  4. Sarah D July 3, 2024

    This sounds like a win for the industry more than for consumers. I’m skeptical.

    • RationalThinker July 3, 2024

      The guidelines are meant to protect consumers by ensuring only valid claims are made. It benefits both sides.

  5. Liam July 3, 2024

    It’s promising that more health claims might be approved in the future. The functional food industry has so much potential.

    • Skeptic32 July 3, 2024

      Potential for what? More profits for big companies?

  6. Anna July 3, 2024

    This could help people make more informed choices about their health, at least in theory.

    • Frank July 3, 2024

      But do most people even read the fine print on these packages?

    • Jessica R July 3, 2024

      Some do, some don’t—but it’s important that the information is there for those who care.

  7. HopefulHenry July 3, 2024

    As someone who uses these products, this is a positive development I can get behind.

  8. Biologist98 July 3, 2024

    Finally, regulated health claims! I’ve been waiting for science to catch up with marketing for years.

    • Skeptic32 July 3, 2024

      Science and marketing? They’re like oil and water.

    • Jane Smith July 3, 2024

      Agreed. Hopefully, this will bridge the gap between credible science and consumer awareness.

  9. TattooedChef July 3, 2024

    Shouldn’t our focus be on educating the public on healthy diets instead of promoting these products?

    • Grower134 July 3, 2024

      Education is important, but people need quick and practical solutions too.

  10. ScienceGuy July 3, 2024

    The specifics of this regulation seem well-thought-out. Kudos to the FDA.

    • Mary Lee July 3, 2024

      Agreed. It’s a signal that they’re listening to scientific advice.

  11. Cindy July 3, 2024

    Eight percent growth in one year? The functional food industry is booming!

    • TonyD July 3, 2024

      That’s because more people are looking for ways to stay healthy without making drastic lifestyle changes.

  12. Larry D July 3, 2024

    I hope this doesn’t just lead to more confusing labels. Clear, simple information is essential.

    • Sarah D July 3, 2024

      True. Sometimes these health claims are too scientifically worded for the average person.

  13. EnvironmentalEco July 3, 2024

    What kind of impact will this have on sustainable food practices? More processed foods isn’t always better.

  14. FitnessFreak July 3, 2024

    What about new fitness supplements? Will they benefit from these new guidelines too?

    • ScienceGuy July 3, 2024

      Yes, as long as they meet the criteria set by the FDA. This should improve overall quality.

  15. Devon July 3, 2024

    Anything that promotes transparency and trust is a good thing, in my opinion.

  16. HealthyLifer July 3, 2024

    The fact that there’s a system for adding new claims based on research is also encouraging. It means it’s an evolving process.

  17. Gina July 3, 2024

    I just hope this helps reduce misinformation. Too many products out there make outrageous claims with no backing.

    • Grower134 July 3, 2024

      That’s why the regulation is a big deal. It will filter out a lot of that nonsense.

    • TattooedChef July 3, 2024

      Or it might just encourage more companies to find clever ways around the rules.

  18. Josh July 3, 2024

    What happens if a company makes a false claim? Is there any penalty?

    • Anna July 3, 2024

      The FDA can take action against misleading claims. Fines and product recalls are possible actions.

    • Jessica R July 3, 2024

      Yeah, they have a process for dealing with non-compliant companies.

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