Vol.

9 Issue 1 Apr-Jun 2011

Maintaining quality standards in nutraceuticals a global overview

Dr. Kirti Wadekar

With the phenomenal growth the nutraceutical industry has experienced over last decade, many more companies want to enter the business. But safety and quality of these products is an issue for consumers and so also for governments. This article portrays the initiatives taken by government authorities globally to maintain the quality standards of nutraceuticals and dietary supplements in respective countries.

utraceuticals, an upcoming healthcare business stream is always in air all over the world (developed as well as emerging markets) due to various amendments in regulation as well as new law formations for the range of products world wide. Every where, regulatory authorities are focusing on the product Quality as it is considered to be of utmost importance keeping in mind consumer's safety as a highest priority. This article gives a snapshot of what is happening on the global regulatory front. CODEX: Codex Alimentarius Commission works to develop food standards, guidelines and related texts such as codes of practice under the Joint FAO/WHO Food Standards Programme in order to protect health of the consumers, ensure fair trade practices in the food trade, and promote coordination of all food standards work undertaken by international governmental and non-governmental organizations. Various governments submit proposals to CODEX committees in order to develop codex standard for respective food items. For example, in 2010, Swiss government submitted the proposal to develop a Codex Standard for Marine Oil (Fish and other Marine Oils) to the Codex Committee on Fats and Oils (CCFO). The committee has agreed to proceed with the development of Codex standard which will

only cover oil from fish and shellfish, whereas algal oils and mammal oils (e.g. seal and whale) are excluded from the scope of the standard. (IADSA Newsflash, Feb 2011). Discussion are also going on with respect to some ingredients like whether to include Steviol Glycosides in food supplements (only chewable food supplements) at the maximum level 2,500 mg/kg, whether Magnesium Stearate (magnesium salts of fatty acids) to be included to GSFA (General Standards for Food Additives), etc. Magnesium Stearate is essential for the production of tablets for food supplements was scheduled for deletion from the codex list. Japan: Being concerned with variances in product quality and what consumers want, Japan Finance Cooperation conducted a survey amongst 2000 consumers (1,000 males and 1,000 females of ages ranging from 20 - 70 years) which highlighted expectations of Japanese consumer in terms of improvements in Uniformity of quality, price of products and stability of supply. More than 50% of Japanese consumers also showed interest in food product issues such as production date, expiry date, country and area of origin, organic certificate, HACCP certificate and traceability system. If traceability system is full proof, they are ready to accept price hike resulting from it.

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European Union: As European Food Safety Authority (EFSA) has started publishing the next batches of Article 13 (generic) health claim opinions from April 2011 onwards, 80% of last month's reviewed claims were rejected because of poor quality of information submitted. For grey submissions where the substances (for instance Probiotics) were insufficiently characterized and were therefore unable to be assessed by EFSA, authority is planning to provide a quarter to submit the required information. EFSA has declared positive opinions for 147 claims of Vitamins & minerals (and their combinations) and 51 claims for other ingredients (including ingredient combinations). Because of increasing negative opinions by EFSA on claims, there is overall suggestion that EFSA should review its assessment methodology given its economic impact on industry and consumers. EFSA has taken one more step towards safety of foods in terms of Genotoxicity Testing. They have launched a public consultation on a draft opinion of its scientific committee covering strategies for carrying such tests with substances used in food and feed. This initiative is expected to support the identification of substances that cause harm to genetic material (DNA) of cells and/or may contribute to the development of chronic diseases such as cancer and heritable diseases. Range of aspects like current experience on combining tests which have varied levels of sensitivity and predictivity; internationally accepted guidelines or protocols for tests; and guidance for use of in-vivo testing taking into account the need to avoid unnecessary animal testing were considered. Denmark: T h e D a n i s h Ve t e r i n a r y a n d F o o d Administration has issued a warning against three products sold via the Internet as musclebuilding and weight loss products because they contain an extract of a plant substance which even in small doses can affect the central nervous system and can cause acute muscle tremors, incontinence and watering of the eyes. Danish Medicines Agency (DMA) is also very concerned about illegal sales of Glucosamine as in recent months, DMA has confiscated over 1451 packages of unauthorized glucosamine. The agency has put out a warning against illegal glucosamine medicines being sold via a Singapore-based Danish website owned by a Danish national along with warning to consumers for not purchasing the same.

France In order to control possible risks from exposure to nano-particles; ANSES, the French Agency for Food, Environment, Health and Occupational Safety, has announced the development of a model as a part of long term 3 year project 'Control Banding'. It categorizes nano-based materials in hazard bands, developed according to the hazard level of known or similar products and taking into account exposure in a work environment. The method is designed to guide risk management decisions by assisting risk managers to apply a graduated response to the potential hazards represented by the nano materials concerned. UK
? Being really firm about the classification of

glucosamine products, The UK Medicines and Healthcare Regulatory Products Agency has recently confirmed its decision to continue with its current position that, in the absence of medicinal claims, products containing glucosamine will not fall within the definition of a medicinal product.
? Since 2008, The UK Advertising Standards Authority (ASA) received 4,500 complaints about online marketing. For smooth processing of these complaints, ASA has launched a sixweek campaign to educate industry and consumers about its new remit, effective from the beginning of March, to police online communications including corporate website messaging and social networking sites. ? To take a step ahead in controlling food contaminants, The UK Food Standards Agency (FSA) has recently commissioned number of surveys like microbiological and chemical contaminants in food, visual post-mortem inspections in pigs, and a study to investigate the effect of processing on pesticide residues in food.

Canada Keeping in mind consumer's interest, Canadian government is taking steps to strengthen the labelling of products which may contain substances which are allergens or sources of gluten. According to new regulation, the label should clearly identify food allergens gluten sources and sulphites either in the list of ingredients or at the end of the list of ingredients with the statement "Contains: Health Canada being strict with unauthorized products, has recalled two products used for weight loss or body building which contains caffeine and synephrine (similar to ephedrine) because of the risk of serious, potentially fatal

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adverse effects from the combination of the ingredients in the product. United States In US, FDA plays a major role in monitoring safety and quality of food products or supplements. In this regards, a recent US FDA inspection of the premises of a dietary supplement manufacturer found a number of serious violations of the Current Good Manufacturing Practice (CGMP) regulations in manufacturing, packaging, labelling, or holding operations for dietary supplements. FDA has clarified that it is the company's responsibility to ensure that their establishment/products comply with GMP regulations, and failure to promptly correct the violations may result in enforcement action which may include seizure of products violating regulations and/or injunction. FDA in joint efforts with Federal Trade Commission (FTC) has announced the withdrawal of a number of products that are sold to treat, cure and prevent sexually transmitted diseases (STDs), including herpes, chlamydia, genital warts, HIV and AIDS. Some of these products are drugs but are labeled as dietary supplements Regarding safety of new dietary ingredients, Supplement manufacturers are required to submit safety information to the federal government before placing a new product on the market. But according to FDA, only 700 new dietary ingredient review applications have come since 1994 out of approximately 60,000 ingredients sold in USA Australia and New Zealand Australian consumers have been warned against the purchase of contaminated Ayurvedic product (with 448g of lead per capsule). Taking two capsules a day of the product in question caused a man seeking back pain relief to ingest more than 30 times the World Health Organization daily limits of 3.5 g. South Africa The Department of Health (DoH) of South Africa has recently implemented Complementary and Alternative Medicines (CAM) dossier inspections. Though Health Products Association of South Africa (HPA) supports this action, it is awaiting the imminent publication of draft regulations for CAM products. The industry will be relieved to have a

legislative programme under which to market their products as there is still confusion in the industry as to what they are allowed to market and claim Taiwan: Effective 1st July, 2011, Department of Health has announced that a sanitary certificate will be required for importation of seafood products in Taiwan. This is to reinforce and harmonize the management of domestic and imported seafood products. In addition, the Department has also requested exporting countries to provide a list of qualified HACCP establishments for guidance and verification. Way forward for India With world coming closer, and food products reaching from one part of the country to another, maintaining safety and quality standards as per various regulatory guidelines set by the respective governments becomes important which can be a real driver for the industry growth. In Indian context, along with FSSA, on the verge of getting implemented, the nutraceutical producers must ensure that they voluntarily implement international best practices in design and development, manufacturing, packaging, quality control and marketing of export-worthy produce. Firms should develop, wherever possible, a more mechanized processing and formulating system, not just to reduce cost but also to conform to WHO-GMP standards. To facilitate the same, it may be a better idea to render services of external experienced training institutes through which companies can have in-house certified trainer who is specifically trained on many of the unique issues of quality specific to dietary supplement industry. This will really be a value add for Indian companies in order to be competent with fast moving world. Thus, with food marketing becoming an increasingly global proposition, it is a must that producers take into account the regulatory aspects of their business to have a healthy future. References: 1. IADSA News flash, March 2011 2. IADSA news flash, April 2011 3. IADSA news flash, May 2011 4.http://www.food.gov.u k/news/newsarchive/2011/may/researchcall 5. Interlink Database

Dr. Kirti Wadekar, Ph. D. in Management, is an expert in nutraceuticals. She handles Project Management of various consulting, competency development and market research assignments at Interlink Marketing Consultancy Pvt. Ltd.

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