IADSA briefs

Red rice medicinal, says EU Court of Justice
The European Court of Justice (ECJ) has recently given its opinion on the classification of a red rice product marketed as a food supplement which contains the active substance monacolin K, which is identical to the cholesterol-lowering agent lovastatin, sold in Germany as a prescription medicine.

The final ECJ ruling was that, apart from products intended for the purpose of making a medical diagnosis, a product cannot be regarded as a medicinal product where its content, if used as intended, is incapable of appreciably restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action.

For further details, see http://curia.europa.eu/jurisp/cgi-bin/form.pl?lang=EN&Submit=Rechercher$docrequire=alldocs&numaff=C-140/07&datefs=&datefe=&nomusuel=&domaine=&mots=&resmax=100

Source: ERNA

OTC cold meds not OK for two-year-old tots, says Health Canada
Following completion of its analysis and further input from a Scientific Advisory Panel, Health Canada has decided that certain over-the-counter (OTC) cough and cold medicines should not be labelled for use in children under 6 and that the necessary label changes should be in place by Autumn 2009. Products for children ages from 6 - 12 will also require enhanced labelling, child resistant packaging, and the inclusion of dosing devices for all liquid formulations.

For more information, visit http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2008/2008_184-eng.php

Source: CHFA

Aussies issue "clinically proven" notice
Concerned by the increasing use of the term 'clinically proven' in advertisements, the The Complaints Resolution Panel of the Australian Therapeutic Goods Authority have published extracts from recent determinations: 'The Panel also noted the use of the words "clinically proven" in relation to the product. Given the strength of this claim and the clear potential for it to mislead and deceive consumers, the Panel considers that its use in advertising should not even be contemplated unless unequivocally supported by robustly designed, published, peer-reviewed clinical trials which have been conducted upon the actual product being advertised or an identical formulation (as a minimum). Even where such evidence is available, the claim must also reflect the weight of all available evidence and not just the specific research being relied upon.'

Further, the Panel also refer to "undue emphasis on the weight of scientific evidence in relation to products." They advise advertisers to make sure that if they '...make representations regarding the efficacy of those therapeutic goods, they must ensure that the strength of the evidence is reflected in the strength of the representations...' and further advise that to do otherwise risks misleading the public and is a breach of the Therapeutic Goods Advertising Code.

Irish lifestyle, attitudes and nutrition survey published
The third 'Survey of Lifestyle, Attitudes and Nutrition in Ireland: Dietary Habits of the Irish Population' (SLAN), has recently been published.

Conducted in 2007, the report majors heavily on dietary compliance with Recommended Daily Allowance (RDA) levels. Although overall, the report found few serious micronutrient deficiencies in the Irish diet, its findings include:

  • Mean folate intake above the RDA of 300 ?g/day. However, overall, 18% of women had a folate intake level below the Average Requirement (AR) level of 230?g/day.
  • Mean calcium intake above the RDA of 800 mg/day. However 24% of women had calcium intake levels below the AR level of 615mg/day.
  • Almost 18% of women had iron intakes below the AR level.

For further details, see: www.slan06.ie/slannutritionreportfinal.pdf

Source: IHTA

FSA to publish list of 'colour-free' brands
The Food Standards Agency (FSA) is encouraging food manufacturers to let them know if they want their company or brands to be included on a list of those free from certain colours.

The colours in question are Sunset Yellow FCF (E110), Quinolene Yellow (E104), Carmiosine (E122), Allura Red (E129), Tartrazine (E102), and Ponceau 4R (E124). The list will be published on the Agency's website, and, while it will not specify individual products, it will provide 'general information that will help consumers identify quickly whether a product they use is likely to contain these colours.'

In related news, Food Standards Australia and New Zealand (FANZ) reported the results of a 2006 survey showing levels of colours in foods showed usage well below maximum permitted levels. FANZ notes the survey provides '.. significant reassurance that there is no public health and safety risk from the consumption of foods containing added colours as part of a balanced diet.'

Unlike the European situation, where food additive regulation includes a warning label for products containing colours linked to hyperactivity and the general view is that the main role of food colours is cosmetic, FSANZ's view is that colours provide '…a visual cue for quality, to induce the perception of flavour and to meet consumer expectations.'

Touchi black bean extract gets first draft endorsement
The Food Standards Agency (FSA) Advisory Committee on Novel Foods and Processes (ACNFP) has issued a draft positive opinion on an ingredient derived from black bean (glycine max), a form of soy known as 'touchi.' The Japanese applicants want to use the ingredient on the European market in dietary supplement and other products to block the absorption of carbohydrates.

In the view of the FSA the fermentation process used to obtain the extract is the same as that for making miso soup and soy sauce, both widely available in Europe, and that therefore no adverse effects are to be expected. However, it should be noted that the draft positive opinion does not constitute approval of any health claim for the product, which would require separate approval under the Health Claims Regulation.

Source: HFMA

FDA Labeling Changes

  • New labelling requirements for colour additives: The FDA is revising its requirements for cochineal extract and carmine. Products must now declare their presence by name, on the product labels.
  • Second version of AER labeling guidance: The FDA has published a further draft of its guidance with regard to labelling requirements of the 'Dietary Supplement and Nonprescription Drug Consumer Protection Act [the Adverse Event Reporting (AER) Bill] and has extending the compliance deadline to January 2010 'because the agency is still in the process of finalising the guidance(s).'
    The guidance requires manufacturers to provide a 'clear, prominent statement information consumers that the domestic address or phone number is for reporting serious adverse events associated with this product,' in contrast to the stated intent of the US Congress, that the legislation 'does not require the label to make any statement other than providing the address or phone number.'
    The supplement industry continues to maintain that the label changes that the FDA guidance seeks go beyond what the legislation requires, and would also mean an unnecessary and heavy cost-burden in terms of label changes.
  • Front-of-pack symbols: The FDA has recently issued a letter to food manufacturers and distributors to inform them about current regulatory schemes and requirements with regard to nutrition claims in the light of the expanding use of front-of-pack symbols on food products.
    The purpose of the letter is to advise that such symbols may constitute nutrient content claims which are subject to Federal labelling regulations, and, depending on the claim, may require disclosure statements.

Source: NPA

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