Japan weighs food/medicine status of four botanicals
At the request of Japan's Ministry of Health, Labour and Welfare (MHLW), the expert research committee which deals with the classification of both plants and chemical substances as drugs or foods has recently published a report on the future classification of various chemicals and four plant species.
The plants in question are:
- Angelica acutiloba (leaf)
- Peucedanum japonicum (root and root stem)
- Hoodia gordonii
- Cissus quadrangularis
Source: NNFA Japan; [email protected]
Ephedra products warning
The Danish Medicines Agency has put out a public safety warning about a product that has been linked to one death and several adverse event reports. The product, which contains both ephedrine (illegal in Denmark), and caffeine, was not registered with the Danish authorities as a food supplement and is therefore classed as an illegal medicinal product. It has mainly been purchased via fitness clubs and the Internet by consumers wishing to boost performance and/or to lose weight.
The European Health Products Manufacturers organization fully supports the action taken by the Danish Medicinal Agency. "We are against the use of these illegal substances in supplements," said EHPM Chairman Peter van Doorn, "And we will continue to work with regulatory authorities to ensure that such products are not available in the European market."
Source: DNI & EHPM European Federation of Associations of Health Product Manufacturers; [email protected]
Exemption from nutrient profiling rules
At the June meeting of the Member States Working Group, the European Commission presented a draft document on nutrient profiling that expressly proposed the exclusion of the application of nutrient profiles to food supplements because of their lack of impact on the diet. This was welcomed by the European Federation of Associations of Health Product Manufacturers.
However, in its draft document the Commission suggested that food supplements be exempted together with other type of foods under a general category that would not provide more than 25kcal per day. However, this limit is not viable for certain type of supplements such as fish oils products and EHPM is hopeful that a suitable solution will be found with the member states and the Commission for all supplements.
Source: EHPM European Federation of Associations of Health Product Manufacturers; [email protected]
FDA approval for isomaltulos
The US Food and Drug Administration has now approved the addition of isomaltulose to the list of non-cariogenic carbohydrate sweeteners that can claim that they do not promote dental caries, on the grounds that it is '...not fermented by oral bacteria to an extend sufficient to lower dental plaque pH to levels that would contribute to erosion of dental enamel.' The type of claim permitted includes 'Does not promote tooth decay,' or 'May reduce the risk of tooth decay,' but such claims can only be used on products whose overall sweetener quantity is low.
Source: NPA Natural Products Association; [email protected]
Association seeks clarity on drug/supplement combos
The American Herbal Products Association has requested that the US Food and Drug Administration clarify its policy on over-the-counter drug-dietary supplement combination products following the recent launch of a new? "analgesic phytosterol supplement." Marketed as 'Aspirin With Heart Advantage,' the product includes 81 mg of aspirin and 400 mg of phytosterols, and bears both OTC drug and dietary supplement labeling and claims.
In its letter to the agency's Assistant Commissioner for Policy, AHPA cites two past warning letters issued to companies marketing OTC drug-dietary supplement combination products without first filing new drug applications. Additionally, the association references a May 30, 2000 letter in which FDA "strongly recommends" firms refrain from marketing these products due to "a number of significant health and policy issues."
Source: AHPA American Herbal Products Association; [email protected]