EU Authorizes Cholesterol Lowering Health Claim For Supplement After 10 Year Wait
Executive Summary
France's Laboratoire Lescuyer can now claim its Limicol botanical extract supplement "reduces blood LDL-cholesterol concentrations" after waiting more than 10 years for approval by the European Commission.
A new EU health claim for a food supplement containing a blend of botanical extracts has been authorized after applicant Laboratoire Lescuyer endured a 10 year wait for a decision.
The European Commission has given the green light to an Article 14(1)(a) health claim referring to a reduction of a disease risk for a combination of artichoke leaf dry extract standardized in caffeoylquinic acids, monacolin K in red yeast rice, sugar-cane derived policosanols, procyanidolic oligomers from French maritime pine bark, garlic dry extract standardized in allicin, d-α-tocopheryl hydrogen succinate, riboflavin and inositol hexanicotinate.
From 10 April, this combination – which Lescuyer markets under the brand name Limicol – can carry the health claim, “reduces blood LDL-cholesterol concentrations. High LDL-cholesterol is a risk factor in the development of coronary heart disease.”
Under the conditions of use set out by the Commission, the health claim may be used only for food supplements which provide 600 mg artichoke leaf dry extract with 30-36 mg caffeoylquinic acids, 500 mg red yeast rice with 2 mg monacolin K, 10 mg sugar-cane derived policosanols, 20 mg French maritime pine bark extract with 18 mg procyanidolic oligomers, 30 mg garlic dry extract with 0,25 mg allicin, 30 mg α-tocopherol equivalents, 5 mg riboflavin and 9 mg inositol hexanicotinate divided in three daily doses to be consumed with the major meals.
Evidence Sufficient
The claim was approved after the European Food Safety Authority concluded that three human intervention studies conducted by two independent research groups showed an effect of Limicol on blood LDL-cholesterol concentrations. This was enough for the regulator to overlook the fact that no evidence was provided for an LDL-cholesterol lowering effect of any of the single food constituents in Limicol at the proposed conditions of use, or as to how the ingredients, individually or in any combination, could contribute to the claimed effect.
Lescuyer has market exclusivity for the health claim as the Commission has granted the Aytré, France-based firm protection of proprietary data for a period of five years for the scientific studies which were central to the approval. However, this does not prevent subsequent applicants from seeking an authorization to use the same health claim, provided that their application is made without reference to the protected scientific data. After five years, the health claim may be used, in conformity with the conditions applying to it, by any food business operator.
With this approval, Limicol is the only food supplement marketed in the EU to benefit from an exclusive reduction of a disease risk health claim. Other authorized Article 14(a) claims for supplements – such as those for vitamin D and folic acid – can be used by any product which complies with the conditions of use.
Food products containing barley beta-glucans, oat beta-glucan or plant stanol esters can carry the authorized claim “has been shown to lower/reduce blood cholesterol,” while there are numerous authorized Article 13(1) general function claims for the “maintenance of normal blood cholesterol concentrations.”
10 Years In The Making
The authorization by the Commission comes over 10 years after Lescuyer’s health claim application was submitted to EFSA for assessment in November 2012. While safety concerns related to one of the supplement’s ingredients contributed to the delay, this application highlights the protracted nature of health claims approval in the EU. This is the first health claim to be authorized by the Commission in two years. (Also see "EU Rejects 8 Health Claims For Foods In 2022, Authorizes None" - HBW Insight, 3 Feb, 2023.)
At first, the authorisation process proceeded at the usual pace. Following requests to Lescuyer to provide additional information, EFSA’s panel on dietetic products, nutrition and allergies (NDA) delivered a positive opinion on the scientific substantiation of the health claim in July 2013.
This opinion was published in the EFSA Journal the same month and passed to the Commission and the Member States.
As EFSA’s NDA panel acknowledged it could not have reached its conclusions without the three human intervention studies provided by Lescuyer, the Commission asked the company to further clarify the justifications provided with regard to its proprietary claim over the studies, and its claim to an exclusive right of reference to those studies.
Lescuyer told the Commission that at the time the application was submitted, it held proprietary right as well as an exclusive right of reference to those studies and that therefore third parties could not lawfully access or use those studies.
At this point the application hit a roadblock. For five years, there was no progress until the Commission published a draft regulation to authorize the claim in October 2018. The Commission noted in the draft that it accepted that Lescuyer had sufficiently substantiated its claims over the scientific studies.
Monacolin K Safety Concerns
But the draft regulation was shelved after the Commission received a concerning EFSA scientific opinion on the safety of monacolins in red yeast rice, one of the extracts in Lescuyer’s Limicol supplement. EFSA’s panel on food additives and nutrient sources added to food (ANS) said it was unable to identify a dietary intake of monacolins from red yeast rice that did not give rise to concerns about harmful effects to health.
The ANS panel judged that the intake of monacolins from red yeast rice via food supplements could lead to exposure to monacolin K within the range of the therapeutic doses of lovastatin, the active ingredient of several drugs authorized for the treatment of hypercholesterolemia in the EU.
Based on adverse effects reports, EFSA said supplements containing monacolins from red yeast rice posed a “significant safety concern” at the use level of 10 mg/day, triggering musculoskeletal and connective tissue, liver, and nervous system issues, amongst others. Individual cases of severe adverse health reactions were also noted at levels as low as 3 mg/day.
Prior to EFSA’s investigation, certain EU member states had raised safety concerns, including the French Agency for Food, Environmental and Occupational Health & Safety as far back as 2014.
As a result of EFSA’s opinion, the Commission in June 2022 added monacolins from red yeast rice to the list of restricted substances in Annex III to Regulation (EC) No 1925/2006 on the addition of vitamins and minerals and of certain other substances to foods.
Given the adverse event reports, individual portions of dietary supplements for daily consumption are now limited to providing less than 3 mg of monacolins from red yeast rice.
Health Claim Prohibited
The Commission’s decision effectively prohibited an Article 13 (1) health claim for monacolins from red yeast rice approved in 2012: “Monacolin K from red yeast rice contributes to the maintenance of normal blood cholesterol levels.”
The claim can no longer be used as it is restricted to food which provides a daily intake of 10 mg of monacolin K from red yeast rice, significantly higher than the new effective limit of 2.9 mg.
Fortunately for Lescuyer, its Limicol supplement provides 500 mg red yeast rice with 2 mg monacolin K per day, allowing the Commission to finally authorize the health claim after more than a decade.