With escalating awareness about Preventive care and health consciousness, Nutraceutical market is growing at a rapid pace in today’s world. The market worth more than $382.5 billion this year and it is expected to reach the market value of $722.4 billion by the end of 2025. Looking at the annual growth rate, in my opinion, Nutra market surely willmake impressive business in upcoming years.

Although the market is expected to strike gold in near future, the regulatory landscape of this sector is emerging as a ‘holding back factor’ for market’s growth. The Nutra regulatory system seem to evolve very slowly compared to the growing number of products being placed into the market. Looking at therisk of fake and unregulated product, market today is asking for strict regulation measures in this field. Being in the grey area between diet and drugs, it is important to clearly identify their specificity in view of their possible use and utility in the pharmaceutical arena.

Drawbacks in Nutra Regulatory framework:

1. No legally globalized definition:
The word ‘Nutraceuticals’ is coined by Stephen DeFeliceand according to him, Nutraceutical is “food or part of a food that provides medical or health benefits, including the prevention and/or treatment of a disease”. This was the basic definition available for nutraceuticals but is every country following the same definition? Absolutely not! Canada refers to nutraceuticals as “natural health products” while the United States calls them “dietary supplements.” So, while setting up a Nutra-marketing campaign in any particular country, finding a right legal definition used in that country becomes a greatest concern to reaches the right audience and avoids confusion. CHART 1 is consisting of definitions of various nomenclatures of Nutraceuticals in some major countries.

2. No uniformity in Regulations:
The lack of shared legislations around the world creates a big confusion while marketing Nutraceutical products worldwide. Proper understanding about the regulations and active regulatory bodies is mandatory for effective marketing. For example, according to Dietary Supplement, Health and Education Act (DSHEA) in US, a dietary supplement should be “a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: vitamins, minerals, amino acids, herbs or other botanicals; a concentrate, metabolite, constituent, extract or combination of the ingredients listed above.” Likewise, in other countries, the formula requirements for the Nutraceutical product might be much different than stated above. Same goes for labelling requirements, they also should be properly studied for the respective country before marketing.

3. Unsubstantiated health claims:
Lack of safety, efficacy and scientific data are the main hurdles while obtaining health claim approval for Nutraceutical products. Nutraceuticals generally are tested only in invitro studies whose evidences are pretty unreliable to comment on thesafety of product. Nutraceuticals are lagging far behind in the field of In vivoresearch, which are obligatory to pass any health claim. Scarcity of regulations in this field to hold back the false claims is still worsening the condition of regulatory landscape.
So, while marketing any Nutraceutical, to protect the sales and credibility of the company, care has to be taken that it should not be marketed as a ‘drug’ (because drugs undergo heavy research and in vivo studies to achieve the health claim).

Country	Nomenclature for Nutraceuticals	Definition
US	Dietary supplements	A product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: vitamins, minerals, amino acids, herbs or other botanicals; a concentrate, metabolite, constituent, extract or combination of the ingredients listed above
European Union	food supplements	Food product whose purpose is to supplement the normal diet and which consists of a concentrated source of nutrients or other substances with nutritional effects or physiological, single or in combination, marketed in dosed formulations, such as capsules, tablets, tablets or pills, designed to be taken in small individual quantities measured
India	Foods for special dietary use or functional foods or nutraceuticals or health supplements	Each Nomenclature has different definition in FSSAI (Website: www.fssai.gov.in)
Canada	Natural Health Products	Substances such as probiotics, herbal remedies, vitamins and minerals, Homeopathic medicines, traditional medicines such as traditional Chinese medicines and other products like amino acids and essential fatty acids
Japan	Foods for Specified Health	foods containing ingredient with functions for health and officially approved to claim its physiological effects on the human body

             CHART 1

4. Lack of Good manufacturing practices:
According to Nutraceuticals World, recent FDA GMP inspections indicated that a good number of dietary supplement manufacturers are not fully compliant with GMPs. Noncompliance with the specifications for ingredients as well as for finished product were investigated. Common violation in this field is failure in verifying purity, identity, composition and strength standards of product batch. This is the major concern seen in the Nutraceutical sector for years.

Owing to all such regulatory deformities, full export potential of Nutraceutical sector cannot be achieved which could be a serious issue with respect to country’s economic status. Sanjaya Mariwala, founder-president of the Association of Herbal and Nutraceuticals Manufacturers of India said, “The governing ecosystem for nutraceuticals needs a serious rethink along with clarity on defining the scope of the sector and its product portfolio. The need of the hour is the creation of a comprehensive HSN [Harmonized System of Nomenclature] repository, with prompt resolution of grievances and export promotion initiatives by a centralised regulatory body, to give teeth to the sector.” He also added, “with limited attention being accorded, the sector’s full export potential cannot be achieved.”

Various countries do have some well-designed regulations for Nutraceuticals but lack of efficient implementation of these guidelines leading to fluctuating outcomes when compared with pharmaceutical sector.
Following are some of the suggestions if implemented can show some positive moves in regulatory framework of Nutraceutical:

• Globalization of guidelines: By executing a well-planned analysis ofexisting regulations employed in various countries and selecting the best approaches can achieve uniformity in regulatory framework worldwide. 
• Like Pharmacopeia, why not Nutracopeia? :An official publication containing a list of natural drugs with their effects, directions for use, tests, etc. can be generated to implement consistency in the regulatory field like pharmaceuticals. 
•  Implementation of transparency by governing bodies
• Risk assessment and verification technologies tied up with more solid inspections and stringent audits
• Like for pharmaceuticals, well-developed laboratories for effective testing and evaluation can be generated to maintain the standards of Nutraceuticals. 
• Internationalization of business to sustain the credibility of employed regulations. 
• Executing regular surveys to assess the degree of improvement 

A restructuring of the entire regulatory framework of Nutraceuticals is necessary to put forth their different purposes and universal definition.Also, to assess their specific role in the prevention and treatment of pathological conditions whichcan be proven by sound scientific and clinical data. A clear and shared regulation system that clearly indicates requirements for quality, efficacy, mechanism of action, safety and a better control can lead to higher quality productswhich could benefit potential consumers as well as the industry.
On the door of 2021, we can clearly see the bright future of life sciences industry ahead, but only when abide by updated regulations. Many more regulations are obliged to come with hidden procedural challenges for compliance. Manufacturers have to be awake with their eyes wide open while launching and marketing products in the presence of new and varying regulations. Keeping track of changing regulatory system is the only way to be updated and profited.
The article has been written by Dr. Smarta-CMD Interlink and published by Saffron Media.