Produced in consultation with IADSA (International Alliance of Dietary Food Supplement Associations)
This is the fourth installment of an ongoing column on the global environment for dietary food supplements. In this column we will provide updates on critical issues, emerging dialogue, international focal areas impacting or potentially impacting the regulation and trade of these products.
For this particular issue, special thanks to David Pineda Ereño, IADSA Manager, Regulatory Affairs and to Ms. MÜGE ÇAKIR, Secretary General / BesDesDer (Turkey)
A draft ‘Regulation for the Sanitary Registration, Control and Surveillance of Pharmaceutical Products and alike’ has been presented in that country, and is of significant concern to the supplements industry. The proposed regulation covers, in addition to pharmaceutical products, herbals and traditional natural products for therapeutic use. The new regulations include requirements for pre-market approval through product registration in an application process that requires detailed scientific and technical information.
In 2002, a law, promoted by industry, was passed that would cover supplements. This ‘law of principle’ would then be further augmented and supported with regulations and guidelines that would influence how it was applied. The proposal to establish this regulation was delayed, and in the intervening time, the government went into a period of transition, issuing instead drug-based regulations which to many, go against the spirit of the ‘law of principle’ developed some years earlier.
It is the opinion of many in industry that the requirements in the current draft are excessive, especially if one notes the long history of use of many traditional natural products for therapeutic use. The latter are ‘traditional’, and in some cases, there is little recorded clinical data/ information available to support the registration of these products.
IADSA, in addition to IPPN (Peruvian Institute of Natural Products – http://www.ippn.org.pe) .and its members, has submitted comments for consideration by the Ministry. These comments argue that requiring proof of efficacy is more for medications, and that the regulations should consider the long use of many of the products. Currently, there is an open process for public consultation (deadline was July 30), and it is as part of this process that IADSA has submitted its comments. It remains to be seen how the government will consider and respond to the opinion that the regulations are of a different spirit to the original law.
In April, in this column, we first spoke about developments in Turkey (http://www.npicenter.com/anm/templates/aroundtheglobe.aspx?articleid=15294&zoneid=143 ).
We’re now able to provide more information after speaking with Muge Cakir, Secretary General of Turkey’s food supplements trade association BesDesDer. Ms. Cakir was extremely helpful in providing us background for the industry and the association, as well as an understanding of where things currently stand.
The results of an excellent and well-cultivated relationship with federal regulators are currently bearing fruit as Turkey moves ever closer to EU membership. BesDesDer, the food supplements trade association in that country, has been actively providing input into evolving regulations in that country since its inception in 2004. BesDesDer members, representing some 98% of the Turkish market for supplements, include notable industry leaders such as Herbalife, Amway and the national Solgar and GNC franchises. The trade association has even taken a stance in its short history to ban a prospective member with suspect advertising practices, an effort which it says has strengthened its position of credibility and trust with Turkish regulators. Last November, the association hosted its first annual one day seminar on supplements, following which it organized an April event attended by the Turkish Minister of Agriculture, the 1st International Symposium on Food Supplements in Turkey, and the event brought out a great voice of the industry. Many stakeholders from the Ministry of Health, the Ministry of Agriculture, Universities, Dietetic and Pharmacy Department heads and sector representatives all attended the symposium to get informed about international regulations and global updates. BesDesDer is planning to hold the 2nd International Symposium with one of the biggest National Universities as the sponsor of this university’s 40th Anniversary next April or May.
Ten years ago, supplements were generally treated as medicines whereas now there is a food supplements determination. The close government relationships have even resulted in the association being invited by the Turkish government to participate in Codex discussions. After patient and professional discussions with the officials and providing them with correct and accurate information, the government has agreed to move forward in a similar way to the EU approach on food supplements.
Regulations regarding food supplements have been presented in Turkey, including a positive list of accepted ingredients. Much of BesDesDer’s current activities, with the support of IADSA, are on the expansion and submission of dossiers that will support an increase in the number of products on the accepted, positive list. The government has expressed a willingness to reconsider the list, when presented with properly formatted safety dossiers. This has resulted in 15 to 20 more herbal products being added to the list in the last 3 months, bringing to approximately 475, the number of herbals on the positive list. (Several products on the list are P*, meaning positive with limitations, such as dandelion.) Damiana, originally not on the positive list, has now been moved to the list after completion and submission of a good dossier on the ingredient’s safety in food supplement uses. This list and status of ingredients is also critical as Turkish Customs officials use these lists to determine which materials to allow, when they inspect products at the country’s 3 chief port cities.
Currently, 4 more dossiers are under consideration covering varieties of mushrooms including reishi and cordyceps.
Turkey is also facing a new food law draft that is very much in line with the new EU food additives regulation, causing the entire issue of food versus medicines to arise. BesDesDer submitted a draft letter to the ministry to point out that these products must be considered as food supplements and part of food law, in part forcing the discussions of the proposed food law to commence anew.
Ms. Cakir observes, “To use political ways, that’s not the only solution. It takes cooperation. If the government doesn’t have good information, then they can’t develop good regulations. Our role is to make sure they have the good information they need.” BesDesDer is working to make it a truthful brandname for Turkish costumer and government bodies.