The story so far…….
Once upon a time, nutraceutical and functional food manufacturers lived and thrived in an unregulated world. Their products addressed a variety of health concerns and came with either implied or overt assurances of safety and efficacy. Sales were good and incidents of side effects or lack of efficacy went unquestioned. As these products did not fall into the ‘drugs’ category, they did not come under the purview of existing drug regulations which demanded proof of safety and efficacy of the drug before it reached the consumer. The creation of a ‘market’ for nutraceuticals was the next best thing that happened to manufacturers since sliced bread.
But now….
Unfortunately, like all fairy tales, this one too came to an end. Law makers stepped in and introduced systems for safeguarding the health and pockets of consumers. Writing a nutraceutical’s success story began to seem like a distant dream.
Dietary supplement (DS) and functional food (FF) manufacturers today are under scrutiny to ensure that they churn out products which really do what they say they do. Simultaneously, they have to race against time to reach the market as soon as possible. Given that the number of DS and FF products lining retail shelves is ballooning everyday, one can well understand their concerns.
As if getting adequate returns on investment on developing the product wasn’t difficult enough, DS and FF manufacturers today have to contend with grabbing a slice of the market. Add to it the fact that in premium markets like the US and the EU, because claim policing authorities are on a 24x7 vigil to trim or eliminate unsubstantiated claims, manufacturers can hardly afford to sit back and relax hoping their coffers would get replenished with no questions asked.
The problem - Regulatory Dragnets
In December 2006, EU decision makers adopted Regulation (EC) no. 1924/20061 to ensure that any nutrition and health claims made on a food label in the EU is clear and substantiated by scientific evidence which would be verified by EFSA (The European Food Safety Authority).
Under the Dietary Supplement Health and Education (DSHEA) Act of 1994, FDA has jurisdiction over the safety and labeling of dietary supplements while the FTC has jurisdiction over advertisements for dietary supplements2 Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 343(r)(6)) requires that a manufacturer of a dietary supplement making a nutritional deficiency, structure/function, or general well-being claim have substantiation that the claim is truthful and not misleading so as to help preserve consumer confidence in his product.3
FDA can either refuse to allow new ingredients into or remove existing ingredients from the marketplace for safety reasons. The label of a dietary supplement product is required to be truthful and not misleading. If the label does not meet this requirement, FDA may remove the product from the marketplace or take other appropriate actions.
The case is quite similar even in other markets around the world where regulators demand to see proof that such products work and are safe to use for the duration of the health condition they address.
If you thought getting regulatory go-aheads was easy, think again! Recently, the USFDA refused a claim for lutein (eye health) 4 EFSA too has a tough image regarding its role in assessing data for claim substantiation. In fact, industry experts feel it’s a notch tougher than even the USFDA. Apparently, only about 2% 5 of the scientific papers presented on clinical trials on nutraceuticals survive the regulatory check post. The reasons for rejection are many, some being poor study design, short treatment duration and too few compliant subjects to allow a sound statistical analysis. Lack of product standardization and other quality issues have also contributed to this failure of data acceptance. The amount of time and money lost due to lack of adequate foresight and planning is heart-wrenching since this could have been well avoided.
Thus DS and FF have to literally go on trial in the regulators’ courts and undergo cross-examination of their efficacy and safety. It is only the quantum and strength of scientific evidence derived from clinical trials that can help manufacturers either win or lose their case and put their products in the hands of consumers or face the penalty of holding back or withdrawing their products from the market.
The solution – CRO assistance
Facing such trials would become easier with the technical and operational support of a Contract Research Organization (CRO). CROs can design and undertake the necessary clinical trials to help DS and FF manufacturers successful in generating the necessary body of evidence to back their product’s label claims in the market they wish to enter.
Evaluating dietary supplements and functional foods requires a different approach as compared to pharmaceuticals in order to ensure that the data generated on the product’s safety and efficacy is scientific and adequate without being unduly excessive and untailored to cater to the need of backing the specific claims the manufacturer wishes to make.
The cost of researching and developing a nutraceutical is lesser than that of a pharmaceutical whether in India or abroad 6 However, the Return on Investment (ROI) on nutraceuticals is also substantially less as compared to that of the latter. One major strategy in maximizing profits then is to cut costs. This can be best achieved by ensuring that the cost of the clinical trial and the time required to generate the necessary evidence for backing claims is tightly controlled. This is easier said than done. Any manufacturer without adequate experience in conducting clinical trials is bound to find the hurdles involved in the process daunting, if not defeating. The costs of conducting studies can be enormous for the uninitiated sponsor. Similarly, the time spent in completing the whole project would put him at a disadvantage as compared to his competitors in reaching the market, not to mention the costs of lost opportunity he would have to bear.
The advantage of using a CRO lies in faster recruitment, and the flexibility it affords by providing additional capacity or expertise in different therapeutic areas. A CRO with strong capabilities and a rich experience in conducting clinical trials (CTs) on nutraceuticals can make all the difference in ensuring that the sponsor has a zero headache deal on obtaining the necessary data for his product within stringent timelines and costs. Vetting the product’s identity, purity and capability and the sponsor’s need to make specific claims requires a thorough understanding of the science behind herbal and other traditional forms of health supplements.
Maintaining your wallet’s health - Offshoring
Having extolled the virtues of CROs then, here is a piece of advice for DS and FF manufacturers in the US / EU and other countries in the West – offshore your clinical trials – it will translate into further savings in time and cost. Countries like India and China today are a hub for clinical trials.
India especially with its diverse patient pool, GCP-trained investigators with specialized knowledge in their specific therapeutic areas, English speaking Clinical Trial personnel, cutting edge laboratory and data capture technology and low man-hour costs are the best bet for a sponsor wishing to minimize costs in product research.
The cost of conducting clinical trials on pharmaceutical products in India is roughly 50% of the cost of the trial when conducted in the US 7 or probably even in the EU. One can then extrapolate this finding to nutraceutical research and development and expect similar if not more reduction in costs in India as compared to the western world.
The strategy – A robust trial design that keeps the end in view
The importance of a well planned, well designed trial in determining the ultimate success of the product cannot be emphasized enough. Only a CRO with expertise in CTs on nutraceuticals can know just how to tweak the study design and manage it operationally to ensure positive outcomes that when collated into a report at the end of the study provide loud and clear evidence on the product’s claims. All this, without compromising on the safety and welfare of the trial subjects and the quality of data generated. Generation of data which would be acceptable to regulators reflects the expertise of a well experienced CRO, as this focus is necessary right from the outset while planning and designing the study.
The design of a nutraceutical trial has a very important role to play in ensuring study outcomes which could have a bearing on the advancement of health and wellness therapies and quality of life standards for patients with various afflictions. Double blind randomized placebo or active comparator controlled clinical trials are the gold standard for generating evidence about the safety and efficacy of a product. Choosing such and closely modified study designs can provide invaluable insights in improving the quality of healthcare. Randomization introduces measures of eliminating bias in treatment allocations. However, a poorly designed randomized trial will not generate credible and useful data on the product as would a well-designed study.
The success of a research trial depends on many factors and the overall strategy that carefully takes them all into consideration. However, the strategy to designing a good trial should be based on the question that one needs to ask regarding the dietary supplement to be evaluated. In his article on research in clinical practice, Dr. Arun Nanivadekar, Former Medical and Research Director, Pfizer India, writes, “The process of research has two aspects: getting an idea is one, and verifying it is the other.” 8 Getting the idea equates with generating the question that would need verification via a trial. Although at times one might find that the research question that ought to be answered is a tough nut to crack, it is imperative that one avoids the easy way out by asking an easier but a useless or a less useful question. Having asked the right question is the first step to designing the trial to get the right answers and to ensure study success.
To quote Jayesh Chaudhary, Founder and CEO of Vedic Lifesciences, a CRO specializing in nutraceutical claim substantiation trials, “Determining the primary question to be asked in a clinical trial of a dietary supplement is critical to its success. Ask a wrong question and you end up with the wrong answer, no answer or an answer that has no market or regulatory value.” 9 Thus in a nutshell, a well designed study can provide the answers to support nutraceutical label claims while maintaining an optimal cost/ benefit ratio thus maximizing profits while minimizing costs.
Making your product’s fairy tale have a happy ending is possible without incurring financial nightmares. Choosing the right CRO and thereby the best study design, is the best way to go about it.
Dr. Aliya Shakeel is Medical Writer at Vedic Lifesciences Pvt. Ltd. For more information on growing yournutraceutical business you can reach her at vedic@vediclifesciences.com or on +91 22 42025703
References
1) Food Science and Technology Ireland Publication of the Institute of Food Science and Technology, Ireland
Volume 2, September 2008
www.icmsf.iit.edu/pdf/FoodScienceTechnologyIrelandVol2-2008.PDF
2) Brackett R. : The Regulation of Dietary Supplements: A Review of Consumer Safeguards
March 9, 2006
http://www.fda.gov/NewsEvents/Testimony/ucm112576.htm
3) Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r) (6) of the Federal Food, Drug, and Cosmetic Act December 2008
http://www.fda.gov/Food/.../ucm073200.htm
4) Qualified Health Claims: Letter of Denial - Xangold® Lutein Esters, Lutein, or Zeaxanthin and Reduced Risk of Age-related Macular Degeneration or Cataract Formation (Docket No. 2004Q-0180)
December 19, 2005
http://www.fda.gov/Food/LabelingNutrition/LabelClaims/QualifiedHealthClaims/ucm073291.htm
5) Berry P: EU health claims and accompanying legislation - time lines
Nutraceuticals International June 01, 2006
http://www.accessmylibrary.com/coms2/summary_0286-15771927_ITM
6) A G Pise, D Sreedhar, M Janodia, V Ligade & N Udupa : Changing paradigms in drug discovery
November 27, 2008
http://www.pharmabiz.com/article/detnews.asp?articleid=47207§ionid=50
7) Clinical trials are now increasingly outsourced to developing countries like India
http://www.offshoringtimes.com/Pages/2006/BPO_news926.html
8) Dr. Nanivadekar A : On research in clinical practice Perspective in clinical research official publication of the Indian Society for clinical research
9) Chaudhari J: Selecting Health Claims for Nutraceutical Clinical Trials
Natural Products Insider 12/21/09
http://www.naturalproductsinsider.com/articles/2009/12/selecting-health-claims-for- nutraceutical-clinical- trials.aspx
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