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Maintaining quality standards in nutraceuticals

a global overview

utraceuticals, an upcoming healthcare only cover oil from fish and shellfish, whereasbusiness stream is always in air all over algal oils and mammal oils (e.g. seal and whale)Nthe world (developed as well as are excluded from the scope of the standard.

emerging markets) due to various amendments (IADSA Newsflash, Feb 2011).in regulation as well as new law formations forthe range of products world wide. Every where, Discussion are also going on with respect toregulatory authorities are focusing on the some ingredients like whether to includeproduct Quality as it is considered to be of Steviol Glycosides in food supplements (onlyutmost importance keeping in mind consumer's chewable food supplements) at the maximumsafety as a highest priority. This article gives a level 2,500 mg/kg, whether Magnesiumsnapshot of what is happening on the global Stearate (magnesium salts of fatty acids) to beregulatory front. included to GSFA (General Standards for Food

Additives), etc. Magnesium Stearate isCODEX: essential for the production of tablets for foodCodex Alimentarius Commission works to supplements was scheduled for deletion fromdevelop food standards, guidelines and related the codex list.texts such as codes of practice under the JointFAO/WHO Food Standards Programme in Japan:order to protect health of the consumers, ensure Being concerned with variances in product

fair trade practices in the food trade, and quality and what consumers want, Japanpromote coordination of all food standards Finance Cooperation conducted a surveywork undertaken by international governmental amongst 2000 consumers (1,000 males andand non-governmental organizations. 1,000 females of ages ranging from 20 - 70

years) which highlighted expectations ofVarious governments submit proposals to Japanese consumer in terms of improvementsCODEX committees in order to develop codex in Uniformity of quality, price of products andstandard for respective food items. For stability of supply. More than 50% of Japaneseexample, in 2010, Swiss government submitted consumers also showed interest in food productthe proposal to develop a Codex Standard for issues such as production date, expiry date,Marine Oil (Fish and other Marine Oils) to the country and area of origin, organic certificate,

Codex Committee on Fats and Oils (CCFO). HACCP certificate and traceability system. IfThe committee has agreed to proceed with the traceability system is full proof, they are readydevelopment of Codex standard which will to accept price hike resulting from it.

With the phenomenal growth the nutraceutical industry has experienced over last decade, many morecompanies 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.

Dr. Kirti Wadekar

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European Union: FranceAs European Food Safety Authority (EFSA) In order to control possible risks from exposurehas started publishing the next batches of to nano-particles; ANSES, the French AgencyArticle 13 (generic) health claim opinions from fo r Fo od , En vir onm en t, He al th an d

April 2011 onwards, 80% of last month's Occupational Safety, has announced thereviewed claims were rejected because of poor development of a model as a part of long term 3quality of information submitted. For grey year project 'Control Banding'. It categorizessubmissions where the substances (for instance nano-based materials in hazard bands,Probiotics) were insufficiently characterized developed according to the hazard level ofand were therefore unable to be assessed by known or similar products and taking intoEFSA, authority is planning to provide a quarter account exposure in a work environment. Theto submit the required information. EFSA has method is designed to guide risk managementdeclared positive opinions for 147 claims of decisions by assisting risk managers to apply aVitamins & minerals (and their combinations) graduated response to the potential hazardsand 51 claims for other ingredients (including represented by the nano materials concerned.

ingredient combinations).UK

Because of increasing negative opinions by ?Being really firm about the classification ofEFSA on claims, there is overall suggestion that glucosamine products, The UK Medicines andEF SA sho ul d r ev ie w i ts as se ss me nt Healthcare Regulatory Products Agency hasmethodology given its economic impact on recently confirmed its decision to continue withindustry and consumers. its current position that, in the absence of

medicinal claims, products containingEFSA has taken one more step towards safety of glucosamine will not fall within the definitionfoods in terms of Genotoxicity Testing. They of a medicinal product.

have launched a public consultation on a draftopinion of its scientific committee covering ?Since 2008, The UK Advertising Standardsstrategies for carrying such tests with Authority (ASA) received 4,500 complaintssubstances used in food and feed. This initiative about online marketing. For smooth processingis expected to support the identification of of these complaints, ASA has launched a six-substances that cause harm to genetic material week campaign to educate industry and(DNA) of cells and/or may contribute to the consumers about its new remit, effective fromdevelopment of chronic diseases such as cancer the beginning of March, to police onlineand heritable diseases. Range of aspects like communications including corporate websitecurrent experience on combining tests which messaging and social networking sites.have varied levels of sensitivity and

predictivity; internationally accepted ?To take a step ahead in controlling foodguidelines or protocols for tests; and guidance contaminants, The UK Food Standards Agencyfor use of in-vivo testing taking into account the (FSA) has recently commissioned number ofneed to avoid unnecessary animal testing were surveys like microbiological and chemicalconsidered. contaminants in food, visual post-mortem

inspections in pigs, and a study to investigateDenmark: the effect of processing on pesticide residues inThe D a n i s h Ve t e r i na ry a nd F oo d food.Administration has issued a warning againstthree products sold via the Internet as muscle- Canada

building and weight loss products because they Keeping in mind consumer's interest, Canadiancontain an extract of a plant substance which government is taking steps to strengthen theeven in small doses can affect the central labelling of products which may containnervous system and can cause acute muscle substances which are allergens or sources oftremors, incontinence and watering of the eyes. gluten. According to new regulation, the labelDanish Medicines Agency (DMA) is also very should clearly identify food allergens glutenconcerned about illegal sales of Glucosamine as sources and sulphites either in the list ofin recent months, DMA has confiscated over ingredients or at the end of the list of ingredients1451 packages of unauthorized glucosamine. with the statement "Contains: The agency has put out a warning against illegal Health Canada being strict with unauthorizedglucosamine medicines being sold via a products, has recalled two products used for

Singapore-based Danish website owned by a weight loss or body building which containsDanish national along with warning to caffeine and synephrine (similar to ephedrine)consumers for not purchasing the same. because of the risk of serious, potentially fatal

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adverse effects from the combination of the legislative programme under which to marketingredients in the product. their products as there is still confusion in theUnited States industry as to what they are allowed to marketIn US, FDA plays a major role in monitoring and claim

safety and quality of food products orsupplements. In this regards, a recent US FDA Taiwan:inspection of the premises of a dietary Effective 1st July, 2011, Department of Healthsupplement manufacturer found a number of has announced that a sanitary certificate will beserious violations of the Current Good required for importation of seafood products inManufacturing Practice (CGMP) regulations in Taiwan. This is to reinforce and harmonize themanufacturing, packaging, labelling, or management of domestic and imported seafoodholding operations for dietary supplements. products. In addition, the Department has alsoFDA has clarified that it is the company's requested exporting countries to provide a listre sp on si bi li ty to en su re tha t th ei r of qualified HACCP establishments forestablishment/products comply with GMP guidance and verification.

regulations, and failure to promptly correct theviolations may result in enforcement action Way forward for Indiawhich may include seizure of products With world coming closer, and food productsviolating regulations and/or injunction. reaching from one part of the country to

another, maintaining safety and qualityFDA in joint efforts with Federal Trade standards as per various regulatory guidelinesCommission (FTC) has announced the set by the respective governments becomeswithdrawal of a number of products that are important which can be a real driver for thesold to treat, cure and prevent sexually industry growth.transmitted diseases (STDs), including herpes, In Indian context, along with FSSA, on the

chlamydia, genital warts, HIV and AIDS. Some verge of getting implemented, the nutraceuticalof these products are drugs but are labeled as producers must ensure that they voluntarilydietary supplements implement international best practices in design

and development, manufacturing, packaging,Regarding safety of new dietary ingredients, quality control and marketing of export-worthySupplement manufacturers are required to produce. Firms should develop, whereversubmit safety information to the federal possible, a more mechanized processing andgovernment before placing a new product on formulating system, not just to reduce cost butthe market. But according to FDA, only 700 also to conform to WHO-GMP standards. Tonew dietary ingredient review applications facilitate the same, it may be a better idea tohave come since 1994 out of approximately render services of external experienced training

60,000 ingredients sold in USA institutes through which companies can havein-house certified trainer who is specifically

Australia and New Zealand trained on many of the unique issues of qualityAustralian consumers have been warned specific to dietary supplement industry. Thisagainst the purchase of contaminated Ayurvedic will really be a value add for Indian companiesproduct (with 448g of lead per capsule). in order to be competent with fast movingTaking two capsules a day of the product in world.question caused a man seeking back pain relief Thus, with food marketing becoming anto ingest more than 30 times the World Health increasingly global proposition, it is a must thatOrganization daily limits of 3.5 g. producers take into account the regulatory

aspects of their business to have a healthySouth Africa future.The Department of Health (DoH) of SouthA f r i c a h a s r e c e n t l y i m p l e m e n t e d References:Complementary and Alternative Medicines 1. IADSA News flash, March 2011(CAM) dossier inspections. Though Health 2. IADSA news flash, April 2011Products Association of South Africa (HPA) 3. IADSA news flash, May 2011supports this action, it is awaiting the imminent 4.http://www.food.gov.upublication of draft regulations for CAM k/news/newsarchive/2011/may/researchcallproducts. The industry will be relieved to have a 5. Interlink Database

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

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