What does Certified Health Declaration mean?

Health Declaration

Statements that describe how a food or supplement contributes to our health are called health claims . For example, saying “Vitamin B6 helps reduce fatigue and tiredness” is a health claim made for vitamin B6.

Certified Health Declaration

The indiscriminate use of such statements or claims by companies for marketing purposes is not permitted. The relevant authorities (Turkish Medicines and Medical Devices Agency , European Federation of Pharmaceuticals and Medical Devices Agency , and the US FDA ) review the scientific evidence regarding the vitamin, mineral, or herbal ingredient in question .

If sufficient evidence exists, the declaration is formally approved and can be used on product labels and in their promotions. A list of these declarations is available on the TİTCK website.

Scientific evidence required for approval:

  • Randomized controlled clinical trials (tests conducted on humans, with reliable results)
  • Meta-analyses and systematic reviews (combined results of multiple studies)
  • Mechanistic biological data (evidence showing how the vitamin works in the body)
  • Safety data (studies showing no side effects with long-term use)

For example, this evidence has been presented, found sufficient, and confirmed for the following health claims regarding vitamin C:

  • Vitamin C contributes to the normal functioning of the immune system.
  • Vitamin C helps reduce fatigue and exhaustion.
  • Vitamin C contributes to normal energy-yielding metabolism.
  • Vitamin C contributes to the normal functioning of the nervous system.
  • Vitamin C contributes to the maintenance of normal psychological functions.
  • Vitamin C helps protect cells against oxidative stress.
  • Vitamin C increases iron absorption.
  • Vitamin C helps with normal collagen formation, which contributes to the normal function of bones, cartilage, teeth, gums, and skin.

The Role of EFSA and TİTCK and the Application Process

EFSA (European Food Safety Authority) is an agency established by the European Union to assess risks in the food and feed chain and provide independent scientific advice. It is also recognized as the sole authority across the EU regarding health claims.
The Turkish Medicines and Medical Devices Agency (TİTCK) bases its health claims on EFSA’s decisions.

EFSA does not approve declarations automatically ; an application is required. This application can be made by companies, national authorities, or industry associations. Approved declarations are then added to the EU’s official list and can be used by anyone, not just the applicant. In other words, the company making the application does not automatically gain the right to use the declaration.

A product may be marketed even if it contains an ingredient or ingredients for which there is no approved health claim. However, unapproved claims, even if frequently used in marketing language, cannot appear on labels and in official advertisements.

Examples of unapproved but commonly used supplements.

Examples of commonly used ingredients on the market that lack officially approved health claims from EFSA/TİTCK include glucosamine, chondroitin, coenzyme Q10, ginkgo biloba, garlic, and spirulina. While these are often marketed with claims such as “improving joint health,” “strengthening memory,” or “boosting immunity,” they are not officially certified.

Examples of commonly used health claims that lack official certification include:

  • Examples of commonly used health claims that lack official certification include:
    • Eklem sağlığı ve osteoartrit için çok popülerdir.Ancak EFSA, kanıtların yetersiz olduğunu belirtmiş ve sağlık beyanlarını reddetmiştir.
  • Coenzyme Q10 (CoQ10)
    • It is marketed as an energy booster and heart health support. The EFSA has rejected the health claims due to inconsistent clinical evidence.
  • L-carnitine
    • It is marketed for energy and fat burning; EFSA has stated that the evidence is inconsistent.
  • Propolis
    • It is commonly used for immunization; there is no approved statement from EFSA.
  • Ginkgo biloba
    • It is widely used with the claim that it improves memory and concentration. However, EFSA has found no strong clinical evidence to support these claims and has rejected them.
  • Spirulina
    • It is marketed as “boosting immunity” or “providing energy.” EFSA has rejected these claims as it does not find them scientifically sufficient.

The belief that these components “are good for something” is generally based on traditional use , preliminary scientific findings (laboratory/animal studies), and small clinical trials . These components may even genuinely benefit some individuals, possibly through a placebo effect. However, because they do not meet the level of large, reproducible, and robust clinical evidence required by EFSA/TİTCK , they have not been granted official health claims.

The popular acceptance of a compound is often backed by theoretically plausible mechanisms of action . In other words, these claims are not entirely unfounded; they have a biochemical and physiological explanation.

For example:

  • Glucosamine / Chondroitin: These substances occur naturally in cartilage. Theoretically, it makes sense that they support joint health.
  • Coenzyme Q10: Plays a role in energy production in mitochondria. Therefore, the claim that it “increases energy” seems biochemically logical.
  • Ginkgo biloba: It is thought to increase blood flow to the brain. Therefore, the claim that it “strengthens memory” can be theoretically explained.
  • Spirulina: Contains protein and antioxidants. Therefore, its claim to “support immunity” is biologically understandable.
  • L-carnitine: Plays a role in converting fatty acids into energy within cells. Therefore, the claim that it “increases fat burning” or “provides energy” seems biochemically logical.
  • Propolis: A bee product, it contains phenolic compounds and flavonoids. Therefore, its claim of “strengthening immunity” is understandable from a biological perspective.

Suggestions

In summary, even if a component’s mechanism of action seems logical and even if positive results are obtained from laboratory or animal studies, a food or supplement must be proven through large and reliable clinical trials in humans to officially receive a “health claim.”

Nevertheless, many people may choose to try the product, influenced by the logical logic of the theoretical mechanism, positive comments they hear from others, and the results of small-scale clinical trials. In this case, choosing products from reputable companies, selecting products approved by the Ministry of Agriculture and Forestry, consulting a healthcare professional, and following the warnings and usage instructions on the product label would be a safe approach.

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