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IADSA briefs

Association position on black cohosh
The Health Products Association of South Africa (HPA) has now formulated its position on black cohosh.

HPA notes that, to date, there is no published scientific evidence supporting the suggestion that black cohosh may have an adverse effect on liver function, and while the available adverse reporting data indicates a possible association between black cohosh and liver disorders in a relatively few rare cases, regulators, clinicians and scientists generally agree that well documented clinical and scientific data proving a causal relationship is lacking.

HPA's view is that black cohosh has a strong history of safe use by millions of women in Europe, the United States and other regions, and many controlled clinical trials support the safety and efficacy of black cohosh preparations in treating menopausal symptoms.

Black cohosh re-approved
Following initial safety concerns on the use of black cohosh for consumers with liver disorders, the Italian Ministry of Health officially re-approved in February the food supplement use of black cohosh (rizoma of Cimicifuga racemosa) on the condition that a specific warning statement is indicated on the product label. This decision has been taken following a safety evaluation of the Italian Ministry Commission on dietetic foods and nutrition in November/December 2006 taking also into account the positions of other EU Member States.

The required label warning statement reads as follows:
"Warning: Do not exceed the recommended dose. For the use of this product and during its consumption period it is recommended to consult a doctor. The product should in any case not be used in case of hepatic disorders or diseases."

Stricter rules on food and drink advertising
New French advertising laws will mean that all advertisements for food and drink products must carry healthy eating messages or face fines of up to 1.5 per cent of their advertising budget.

In a move to tackle obesity, at least seven per cent of the page of television or media advertisements must carry one of four messages: Avoid snacking between meals; Avoid eating too much salt, sugar or fat; take regular exercise; Eat at least five portions of fruit and vegetables every day.

The French supplement association, SDCA, is seeking assurances from its authorities that food supplements will be not be required to use these specific messages on their products. So far however, although promises have been made, no official assurance of modification to the required texts has been received and if necessary SDCA will consider further action in April.

EBF Model for Botanical Safety Assessment
The safety evaluation model for botanicals developed by the European Botanical Forum (EBF) has now been published in the journal The Annals of Metabolism and Nutrition.

Based on the current European Union legal framework for herbals/botanicals, including the Traditional Herbal Medicinal Products Directive, the General Food Law Regulation, the Food Supplements Directive and the Nutrition and Health Claims on Foods Regulation, the EBF paper offers a model to classify botanicals on a case by case basis:

  • Botanicals conventionally used in foods or supplements and recognized as safe in normal use.
  • Botanicals with conventional food or supplement use but at concentrations which would result in higher intake than under normal conditions.
  • Botanicals not conventionally used in food or supplements.
  • Botanicals that would be dangerous in food of food supplements because of their toxicity.

It is hoped that the model will be used to inform the discussions of the various bodies working on the regulatory framework for botanicals, which include both the Council of Europe and the European Food Safety Authority.

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