Botanical supplements: traceability, transparency and trust

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BOTANICAL SUPPLEMENTS: TRACEABILITY, TRANSPARENCY AND TRUST THEMATIC SERIES

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BOTANICAL SUPPLEMENTS: TRACEABILITY, TRANSPARENCY AND TRUST

OVERVIEW

RAMPING UP ON BOTANICAL TRACEABILITY New York Attorney-General Eric Schneiderman and some fellow US AGs certainly stirred things up during 2015 for the herbal supplements industry on alleged dubious botanical origins and erroneous labeling.1 This served to highlight a divergence of interpretations between the industry and the authorities and the need for more transparency and information sharing from the industry to avoid future misinterpretations.

However, 2015 may have encouraged botanical supplements industry to kick it up a notch and separate the wheat from the chaff. This way, quality retailers, manufacturers and suppliers – in the US and beyond – can stand out, and enabling consumers to recognize and value that quality.

Despite a rocky 2015, it seems that US supplement consumer confidence has not been dented, with supplement sales increasing from 5,9% between 2014 and 2015.2

US HERBALS & BOTANICALS SALES TRENDS2

US DIETARY SUPPLEMENT SALES TRENDS2

Botanical ingredients are the stars of herbal supplements, so ensuring that their credentials are top-notch is one of the most important parts of the entire process from seed to shelf. The necessary frameworks and technologies are already available to do this.

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BOTANICAL SUPPLEMENTS: TRACEABILITY, TRANSPARENCY AND TRUST

OVERVIEW

DIETARY SUPPLEMENTS IN THE US: WHICH USE FOR WHICH GENDER?3

SOURCING TRACEABILITY SOLUTIONS The road to complete traceability is long and entails adopting rigorous and consistent processes, keeping abreast of evolutions in regulations and technologies, and building long term relationships with ethical and rigorous partners. A flawless and efficient natural supplement demands the best ingredients that Mother Nature has to offer. So how does a manufacturer ensure its consumers that it's exactly what they are getting?

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BOTANICAL SUPPLEMENTS: TRACEABILITY, TRANSPARENCY AND TRUST

OVERVIEW

THREE MAIN INGREDIENT SUPPLIERS Brokers buy and sell products on demand

*

$

$

0,0 $

Distributors stock the products purchased from the manufacturers

* $

0,0 $

Manufacturers source and produce the raw materials themselves

* 0,0 $

A botanical ingredient is only as good as its origin and initial treatment: where and how it was grown, harvested and processed or extracted. Manufacturers are the most closely involved with the raw material cultivator and thus are the most able to ensure full traceability, verifying and documenting the essential information on a plant's identity and properties.

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BOTANICAL SUPPLEMENTS: TRACEABILITY, TRANSPARENCY AND TRUST

OVERVIEW

US CONSUMER ATTITUDES TO DIETARY SUPPLEMENTS IN 20153

REGULATORY OVERSIGHT AND SELF-REGULATION – MORE OR LESS? The dietary supplement industry is regulated differently across countries, together with an important component of self-regulation.

In the US, the Dietary Supplement Health and Education Act was passed in 1994, with provisions made on good manufacturing practices (GMPs), including plant identity. These provisions are enforced on products already on the market through a system of FDA inspections.

In other countries, including the European Union, approvals and checks happen before a supplement reaches the market. Often lengthy, these processes can hold up market releases for years, added to the complications of individual countries differing legislation.

It is this unevenness in regulatory harmony which makes the parallel industry self-regulation initiatives so important – they protect and inform consumers and proactively ensure compliancy.

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BOTANICAL SUPPLEMENTS: TRACEABILITY, TRANSPARENCY AND TRUST

OVERVIEW

DELIVERING TRACEABILITY, TRANSPARENCY AND BUILDING TRUST… There is an ongoing debate around the world between watchdogs, industry associations and governments on the optimal level and scope of regulation. But none of it will take away from the supplement industry’s own ongoing efforts to improve its processes, checks and trade group membership criteria; building trust with consumers and demonstrating responsible leadership to regulators.

But today, consumers demand access to this information too. And it is gradually becoming a market differentiator – a trend that will only increase as transparency becomes more prevalent across other industries and services.

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GOOGLE 2016 KEYWORD SEARCH RESULTS4

BOTANICAL SUPPLEMENTS: TRACEABILITY, TRANSPARENCY AND TRUST

OVERVIEW

GETTING TO THE TRUTH OF THE MATTER

GOOGLE SCHOLAR KEYWORD SEARCH RESULTS5

In their drive to manage and personalize their health care, consumers need to be able to differentiate between natural and synthetic supplements, and their differing origins, potencies, actives and value for money.

English language Google searches on botanicals and dietary supplements will pull up literally millions of references. The number of published scientific nutritional studies which are sometimes contradictory, has almost tripled since 2000, according to what’s available on Google Scholar.5 A search on Amazon.com will show you there are more than 900 cranberry supplement references, with prices from $4-$80 for 60 tablets.6 How is a consumer supposed to fight their way through all of this and find an efficient, good value-for-money supplement – especially if the label holds limited clues?

Increased transparency will help both medical professionals and consumers identify the very best products that the botanical supplement industry has to offer, building brand reputation and loyalty.

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BOTANICAL SUPPLEMENTS: TRACEABILITY, TRANSPARENCY AND TRUST

FOCUS

BOTANICAL IDENTITY AND TRACEABILITY For a quality botanical ingredient supplier, ‘testing’ per se starts long before the ingredient gets anywhere near being ordered, purchased or perhaps even grown, for those suppliers that do grow their own. Quality checks and controls start from the R&D phase when botanicals with potential are identified and the quest for an optimal source begins.

A CONTINUOUS AND VARIABLE CIRCLE OF TESTS AND CHECKS There is an extensive suite of possible tests that can be carried out on botanical ingredients, some depending on the plant’s own structure. A good number are generally applicable and have been in place and constantly evolving over decades.

But not all tests work in the same way on every plant and so specific tests have and will continue to be devised for some plants, geographies or formulations.

Avoiding adulteration means guaranteeing the right species, plant part and actives.

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Test results will include essential information on the botanical raw material, extract or ingredient : • Identification – confirmation of the exact botanical species • Purity – that there is no adulteration, and if there is, to what extent and origin • Potency – that there is no depletion; that it retains a complete range of active properties • Spiking – that there is no extra fortification, adding of actives that don’t occur naturally • Substitution – that as it says, the botanical has not been substituted for another one • Contamination – that no banned pesticides are used in cultivation. That there are no heavy metals or other pollutants and that these are not introduced during processing.

At the same time, extensive procedures and checks will be undertaken to ensure GMP compliance (and possible improvements): compliance with local and national legislation, sustainability and benefit sharing protocols, verification of organic and GMO status and other relevant certifications, along with the setup of quality control mechanisms and performance monitoring and audit plans for the future.

BOTANICAL SUPPLEMENTS: TRACEABILITY, TRANSPARENCY AND TRUST

FOCUS

KEYS TO PROPER BOTANICAL AUTHENTIFICATION HOW TO PROPERLY IDENTIFY BOTANICALS AND ACTIVE CONSTITUENTS?

ORGANOLEPTIC

CHARACTERIZATION ON CRUDE RAW MATERIAL

TEST EXAMPLE OF WHAT IT CAN AND CAN’T TELL US

CHEMICAL

CHARACTERIZATION ON CRUDE RAW MATERIAL AND/OR BOTANICAL EXTRACT

MACROSCOPY & MICROSCOPY

ODOR TASTE

HPTLC

CAN confirm ginkgo biloba species

CAN confirm chamomile genus

CAN confirm devil’s claw genus

CAN’T distinguish ginseng species (Asian vs American)

CAN’T distinguish licorice species (glabra vs uralensis)

CAN’T distinguish devil’s claw species (harpagophytum zeyheri vs procumbens)

HPLC

CAN distinguish bilberry vs blueberry species due to distinct anthocyaninprofiles (vaccinium myrtillus vs angustifolium) CAN’T distinguish barberry species (berberis vulgaris vs asiatica)

GENE MATERIAL

CHARACTERIZATION ON CRUDE RAW MATERIAL AND SOMETIMES BOTANICAL EXTRACT

DNA TESTING

CAN provide powerful detection for species IF a validated method and reference material are used.

CAN’T detect synthetic added compounds

RIGHT SPECIES RIGHT PLANT PART RIGHT ACTIVE Provides conclusive results for most botanicals

Provides conclusive results for some botanicals

Routine tests

Provides little or no information

Experimental stage (cannot be used in routine)

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BOTANICAL SUPPLEMENTS: TRACEABILITY, TRANSPARENCY AND TRUST

FOCUS

WHEN IS THE RIGHT TIME TO USE DNA BARCODING? DNA barcoding is a relatively recent arrival to the suite of botanical testing solutions and is useful to identify different species of plant within the same family. However, it can confirm a species only if there is existing reference material to which a sample can be compared; but as the number of botanicals references increases, and the technology advances, more laboratories are offering this test.

So first of all, the species must exist in a formal botanical register, against which the plant is sequenced and compared. This will confirm the plant species, but cannot tell which part of the plant is being used – for instance leaf, stem or bark – so other tests are required to confirm the part of the plant. This is vital information as only a certain part of a plant may contain the active properties, and very importantly, another part of the plant could even be toxic. DNA barcoding is not usually suitable for botanical extracts either, as the more a plant is processed; the less original DNA is found within. Therefore at the stage of a botanical extract, very little, if any DNA remains.

In addition, DNA barcoding is still a challenge as the smallest contamination of the samples can alter the analysis and lead to false results.

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It is also worth noting that even if raw materials under the same name, such as Devil’s Claw, come from a different species of the same family, it is not necessarily a negative. In this particular case, both species (Harpagophytum procumbens and the closely related Harpagophytum zeyheri) have equal active properties. Here, it is more a question of transparency – clearly documenting and communicating the facts to avoid confusion or misinterpretation.

DNA barcoding to confirm the genetic origin of raw botanical materials is an exciting advance in the quest for full traceability, but it cannot tick all the required boxes. In the current state of research and knowledge, DNA barcoding is still a challenge and cannot be used as a routine test.

As shown in the graphics, a full suite of tests is required to measure and confirm plant parts and properties.

With a quality botanical ingredient supplier, traceability goes hand-in-hand with botanical expertise, supporting substantive studies, clean manufacturing practices, and systems and checks that go all the way back to the field in which the plant has grown.

BOTANICAL SUPPLEMENTS: TRACEABILITY, TRANSPARENCY AND TRUST

FOCUS

WHAT CAN’T DNA TESTING TELL US?

IDENTITY

QUALITY

STRENGTH

Am I using the right plant part?

What is the quality of the raw material used?

Is my extract rich in actives for the TARGET BENEFIT?

Are there contaminants or synthetic compounds?

DNA testing of plant material from the field

DNA testing of plant material during harvesting and processing

DNA testing of plant material after extraction and purification

DNA testing of plant material in a finished product

CANNOT distinguish if you are using the right plant part

CANNOT distinguish between quality & type of processing

CANNOT quantify the amount of an active compound available

CANNOT detect if high levels of contaminants are present

example

Ginseng Root or Ginseng Plant?

Field

example

Panax Ginseng or Red Panax Ginseng?

Harvesting Processing

DNA quantity/quality Intact plant material

example

Ginsenosides within ginseng root extract?

Extraction Purification

From harvest to finished product, as plants are processed the amount of DNA is damaged or fragmented

PURITY

example

Are pesticides present?

Finished Products Processed plant

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BOTANICAL SUPPLEMENTS: TRACEABILITY, TRANSPARENCY AND TRUST

SOLUTION

DELIVERING A QUALITY BOTANICAL INGREDIENT… WITH A CLEAR AND TRUE HEALTH STORY Dietary supplements don’t get much positive media coverage in the US. In the developed world, complementary remedy providers are often portrayed as selling snake oil to gullible consumers. Modern man perhaps forgets that Nature has developed and delivered medicinal compounds since the beginning of time, and that it is largely due to mankind’s traditional knowledge and use of such natural remedies that many allopathic medicines now exist.

As of 2012, some 35,000-70,000 plant species have been screened for their medicinal use.7 Despite scientific studies to the contrary, the ‘establishment’ is reticent to give health credit to herbal supplements. And yet, many millions of consumers from the four corners of the world continue to put their faith in natural supplements.

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BOTANICALLY DERIVED DRUGS7

BOTANICAL SUPPLEMENTS: TRACEABILITY, TRANSPARENCY AND TRUST

SOLUTION

DIETARY SUPPLEMENTING IS HERE TO STAY

TOP 6 HERBAL/BOTANICAL SUPPLEMENTS SALES IN US IN 20153

Naturally ‘supplementing,’ has always been around and allopathic medicine recognizes that nutrient needs change throughout a lifetime. In traditional systems such as Traditional Chinese Medicine or Indian Ayurveda, the approach is highly personalized – recognizing each individual’s makeup and needs, to concoct treatment combinations accordingly. Modern botanical supplements are a modern offshoot of these principles, enabled on a global level by today’s technology and science.

‘Modern’ people continue to research and seek professional medical guidance on natural ingredients that fit with their particular health and wellbeing needs, with 31% of US supplement users taking herbals and botanicals in 2015.3 And as product offers multiply, it is easier for consumers to move sideways, switching to products with better images, proven track records or clear brand stories.

TRANSPARENCY - CLEAR LABEL TO STORYTELLING It is vital for supplement retailers and their partners to source superior active botanical ingredients, conserve these actives during the manufacturing process and rigorously test, validate, document AND communicate their properties and benefits. It does not end with a marketing drive, but requires proactive, contextual storytelling, precise crisis communications planning and professional social media operations.

While having an honest and clear label is an important and essential first step, it is not enough to successfully position products above the hubris of information overkill. Depending on the active ingredients, health claims and brand promise, each product or active ingredient needs its own story. Not so much technical jargon and formulas, but a story in words and images of the ingredient’s lifecycle, its traditional heritage, modern scientific backing and the quality and ethics of its manufacturing process.

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BOTANICAL SUPPLEMENTS: TRACEABILITY, TRANSPARENCY AND TRUST

SOLUTION

DEMANDING THE VERY BEST FROM BOTANICAL INGREDIENT SUPPLIERS Whether a supplement manufacturer or a botanical ingredient distributor, there is a checklist of boxes that a quality botanical ingredient supplier should be able to tick off:

Is the supplier a member of major industry groups: international, regional or national?

Does the supplier have in-house testing facilities, or work with accredited testing agencies?

Is the ingredient’s efficacy supported by substantive studies and/or approved health claims?

Does the supplier have local purchasing offices, close to the ingredient sources?

Are the supplier’s processes and products compliant with local legislation? does the supplier provide all the elements of a good ingredient story?

Is there documented evidence of systematic audits on raw material suppliers?

Does the supplier produce formal documentation on plant identity, actives, standardization etc.?

Will the supplier’s processes and products stand up to regulatory scrutiny?

Is the supplier engaged in a sustainability program?

It may seem like a lot to expect from a supplier, but clean and clear ingredients from the very outset will positively contribute to a superior product, brand value and the assurance of regulatory compliance.

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BOTANICAL SUPPLEMENTS: TRACEABILITY, TRANSPARENCY AND TRUST

SOLUTION

TWO RAW MATERIALS: TWO FULLY TRACED AND CONFIRMED PROFILES Naturex has developed a comprehensive document : the ID pack, currently available for 50 plants.

Green Tea Leaf extract, an example of a fully traced and confirmed profile: discover the video on Naturex’s Youtube channel.

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BOTANICAL SUPPLEMENTS: TRACEABILITY, TRANSPARENCY AND TRUST

SUMMARY

8.566

US herbs & botanical

million in 2019

sales could reach

TOP 6

herbal/botanical supplements sales in US in 2015

TURMERIC

CRANBERRY

48.913 million in 2019

US dietary supplements

sales could reach

SAW PALMETTO

ECHINACEA

GREEN TEA

MILK THISTLE

$163M $149M $145M $140M $135M $131M

78% OF US CONSUMERS think dietary supplements are

SMART

and have overall confidence in

SUPPLEMENTS

CHOICE

LABELLING

3 MAIN

SUPPLIERS

of natural ingredient

manufacturers

distributors

brokers

NATUREX GUARANTEES FULL TRACEABILITY & SUSTAINABILITY WITH TRACE & PATHFINDER PROGRAMS

NATURES’ ID PACK ENABLES CAREFUL TESTING

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BOTANICAL SUPPLEMENTS: TRACEABILITY, TRANSPARENCY AND TRUST

SOURCES

SOURCES/LINKS: 1/ S. Daniells, The NY AG’s herbal probe so far: From GNC to devil’s claw; NutraIngredients-USA, 11 September 2015 http://www.nutraingredients-usa.com/Manufacturers/The-NY-A G-s-herbal-probe-so-far-From-GNC-to-devil-s-claw 2/ Healthy Solutions Report 2015: US Nutrition Industry Sales by Product, 2004-2020e; Nutrition Business Journal, April 2016.

Available at http://newhope.com/catalog/back-issues 3/ Council for Responsible Nutrition, The Dietary Supplement Consumer, 2015 CRN Consumer Survey on Dietary Supplements. Available at http://www.crnusa.org/CRNconsumersurvey/2015/what.html 4/ Google search at https://google.com/ 5/ Google Scholar at https://scholar.google.com/ 6 / Amazon.com at http://www.amazon.com/s/ref=sr_nr_n_1?fst=as%3Aoff&rh=n %3A3760901%2Cn%3A3765381%2Ck%3Acranberry+supplem ent&keywords=cranberry+supplement&ie=UTF8&qid=1463221 470&rnid=3760931

Design & supervision: Havas Worldwide Paris / writing: Mensquare / pictures: Shutterstock.

Non-contractual pictures and illustrations.

7/ C. Veeresham, Natural products derived from plants as a source of drugs; Journal of Advanced Pharmaceutical Technology & Research. 2012;3(4):200-201. Available at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3560124/

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Looking after one’s health is even better when it’s done with efficient and natural solutions!

Our customers put their trust in our knowledge of plants and our continuous innovation process because we are committed to helping them switch from synthetic to natural.

Your Natural Selfcare Team.

For more information, please contact : Email: naturex@naturex.com Phone: +33 (0)4 90 23 96 89 | Fax: +33 (0)4 90 23 73 40 Naturex SA - 250 rue Pierre Bayle - BP 81218 84911 AVIGNON cedex 9 - FRANCE www.naturex.com

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