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False Advertising & Label Claims in the Dietary Supplement Industry

Nutritional Products International (NPI) has written an article on false advertising and label claims within the dietary supplement industry.

According to this recent article, the dietary supplement industry is growing at a rate of 7-10% per year in the US. With this growth, the number of different dietary supplements available on the market also continues to increase. As consumers continue to purchase supplements in order to help solve a variety of health issues and to improve general health, it is more important than ever that any claims being made are accurate.

In the US, the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) regulate any health claims being made. Any false advertisement or inaccurate label claims being made for dietary supplements are picked up by these authorities. Any company found to in breach of applicable regulations can face consequences of a class action lawsuit and even fines. Read the full article here.

In the UK, food supplements are regulated under the food law, which falls under the Food Safety Act of 1990. The Health and Food Supplements Information Service (HSIS) provide really useful information on the regulation of food supplements (see the link here).

The general advice is to contact your local authority and specialists to ensure that any advertising or label claims meet all relevant regulations. As well as this, laboratory testing of your product will help you ensure that what is written on the label is actually present within the product. Laboratory testing can also ensure that any prohibited or undesirable ingredients are not present.

The ultimate goal is to ensure that the safety and the quality of your products are of the highest standard. Introducing various analytical techniques can be a useful part of your quality control regime to help reach this goal.

If you need your label claims on your dietary supplement or nutraceuticals confirmed via laboratory analysis then contact us today.

Stability Testing of Supplements

Stability studies are useful tools to help you understand the stability of your supplements over a given shelf life.

Here at ICNE Ltd., we can help you manage all of your stability testing requirements. Read more about stability testing in our Stability Testing Guidance document for supplements by clicking the image below:

ICNE Stability Testing Guidance

If you are interested in stability testing on your supplements then contact ICNE today on 01253 737009 or email info@icne.co.uk.

Iodine Value – Method Validation

Iodine Value is the measure of unsaturation of an oil, fat or wax. Oils, fats and waxes contain hydrocarbon chains which can be saturated or unsaturated. A saturated compound contains only single bonds between carbon atoms. Unsaturated compounds contain double or triple bonds between carbon atoms. The higher the number of double or triple bonds in a molecule i.e. the higher the degree of unsaturation, the more reactive and therefore the less stable the molecule is. This means that with a higher unsaturation level, the more prone a compound is to oxidation and rancidification.

How Does the Iodine Value Test Work?

The iodine value is determined by measuring the amount (in grams) of iodine in a solution that is taken up by 100g of oil, fat or wax. In comparison to unsaturated molecules, saturated molecules are not very reactive with iodine, therefore the iodine is not taken up by the saturated oils. As unsaturated molecules are more reactive they can more readily react with the iodine. In the iodine value method, a solution of iodine bromide is allowed to react with the sample. This will allow any double bonds in the sample to react with the iodine. Potassium iodide is then added which reacts with any un-reacted iodine bromide solution to form molecular iodine. The iodine is then titrated with Sodium Thiosulphate with an indicator of starch solution, until a yellow colour is discharged. A calculation is then made to determine the Iodine Value.

Testing Iodine Value at ICNE

Here at ICNE, we have validated the European Pharmacopoeia 2.5.4 Iodine Value (Method A). We are able to use this method for any raw material that has a Ph. Eur. Monograph, and where one of the tests listed is Iodine Value, Method A.

Assessments are made in duplicate along with a control blank sample. If you require Iodine Value analysis of your raw materials, using the Ph. Eur. Iodine Value Method A, then contact ICNE today for a quote on 01253 737009 or info@icne.co.uk.

Meet the ICNE team – Helen Zachariassen (Analyst)

Helen Zachariassen (Analyst)

BSc (Hons) Forensic Science

From 2004, Helen worked for the Individual Restaurant Company, where she started as an Office Junior. Within 2 years, Helen quickly progressed and was promoted to Payroll Manager. After 9 years with the company, Helen made the very big decision to leave that industry to attend university in order to follow her dream of working within the Science sector.

In 2013, Helen started a BSc Forensic Science undergraduate degree at the University of Central Lancashire. Helen gained experience in biological and chemical laboratory techniques and graduated from university in June 2016 with Honours.

Immediately after graduating, Helen was offered a temporary position as an analyst here at ICNE. Helen is now a permanent member of the ICNE team where she carries out a wide range of analytical techniques on raw materials and finished products, creates reports and performs routine equipment calibrations.

Meet the ICNE team – Stanley Graham (Analyst)

Stanley Graham – Analyst

BSc (Hons) and MChem Chemistry & Forensic Science

In 2016, Stanley graduated from Bradford University with a BSc (Hons) and MChem in Chemistry & Forensic Science. At University, Stanley learnt a variety of analytical techniques including (but not limited too) HPLC analysis, Electron Microscopy and UV Vis Spectroscopy.

In early 2017, Stanley joined the ICNE team as an analyst. He has since been in laboratory training at ICNE, and now Stanley routinely carries out a range of analytical techniques, creates reports and performs routine equipment calibrations.

Importance of pH Testing in Finished Products

DEFINITION OF pH

pH is the measurement of acidity or alkalinity of a solution. It is the negative logarithm of the activity of hydrogen ions (H+). There is an inverse relationship between pH and concentration of H+, therefore when the concentration of H+ ([H+]) is high the pH is low. The pH is expressed as the concentration of [H+] (or acid) and the pH scale ranges from 0 to 14, whereby the lower pH is acidic, 7 is neutral and the higher pH is basic or alkaline.

ICNE pH Scale

As the measurement is logarithmic, the slightest change in pH can be significant. 1.0pH unit means the [H+] differs by a factor of 10. Therefore the [H+] at pH 3 is 10 times greater than at pH 4, and 100 times greater than at pH 5.

HOW DO YOU MEASURE pH?

PH can be measured in multiple ways, from the basic pH indicator strips, small pocket and handheld meters, to more comprehensive and accurate bench top meters. Using bench top meters, the pH is determined by measuring the potential difference between 2 electrodes which is analysed with a voltmeter. One of the electrodes is sensitive to [H+] (usually a glass electrode) and the other is a reference electrode (i.e. silver-silver chloride electrode). These electrodes are usually combined into one compact electrode.

WHY SHOULD YOU TEST FOR pH?

In development of a finished product, the pH is carefully considered in order to provide optimal conditions for certain ingredients. In cosmetics, some preservatives and active ingredients may only work or be active at a given pH. For example, enzymes work at a more alkaline pH. Also, the activity of amphoteric surfactants (a compound that can react as either a base or an acid) is dependent on the charge that they acquire, which is based on the pH. This can determine how the surfactants interact with other ingredients.

In developing a new cosmetic, the natural pH of the body must be taken into account. The natural pH of the scalp is slightly acidic whereas the skin is slightly alkaline. In order to maintain the optimal conditions, the pH of a product which is applied to the body must be controlled. In terms of functionality of a product, the pH can be very important. For example, hair dyes are alkaline which helps open the cuticles of the hair, therefore allowing penetration of the dye to the hair follicle. The hair dye conditioner used after the dying process is acidic, causing the cuticles to retract back and for the scalp to return back to a more natural pH.

For safety purposed, it is very important to avoid extremes in pH in order to protect the skin from damage. Extreme pH can damage the skin barrier which can result in transepidermal water loss, meaning that the skin can be more prone to chemical and microbiological attack. Also, a low pH can help reduce the growth of various microorganisms within a product. Some microorganisms can pose a safety risk and can also affect the shelf life and stability of a product.

The level of pH can also affect the organoleptic conditions of a given product. For instance the solubility of ingredients is determined by the pH, which in turn can alter the physical and microbiological stability of the product.

In the hygiene industry, the pH of the product can determine the end use of the finished product. More acidic cleaning products are de-scaling products, toilet cleaner, and sulphuric acid drain cleaners and alkaline products are bleach, ammonia and borax, all of which have completely different applications.

WHAT ARE BENEFITS OF pH TESTING FOR A COMPANY?

It is important for the pH to be analysed prior to authorising release of a batch to the consumer. If a product does not meet the pH specification, which has been carefully decided by the manufacturer, then there is a risk that the product will not perform as expected and as marketed and most importantly, may pose a major safety risk.

pH has an important role to play in various industries including cosmetics and hygiene. Analysis of pH levels is a relatively cheap, quick and effective way to perform a quality control check to see if a certain batch meets the products pH specification. Ultimately, it is one way of ensuring that you as the manufacturer are consistently producing high quality and safe products for your customers.

pH TESTING AT ICNE LTD

Here at ICNE Ltd, we routinely perform pH testing for our customers. The method for pH analysis appears on our UKAS ISO17025 schedule for accreditation and we are also enrolled on the PHARMASSURE proficiency scheme for pH testing, to ensure that our results are compared to a standards’ results. For pH analysis, we use a modified European Pharmacopoeia method, and use a bench top meter, with an accuracy of 0.01 pH units. Our pH meter is calibrated on a daily basis, more so if an extended low or high pH calibration is required. It is calibrated against a range of certified pH buffers covering the full pH scale. For every pH measurement, we perform a quality control check with a buffer of a certified value, and then perform the analysis in duplicate. The calculated uncertainty of our methodology is ± 0.05pH units.

If you need your finished products tested for pH levels by an independent accredited laboratory, then contact us today on 01253 737 009 or via email info@icne.co.uk

ICNE Ltd Business Ownership Transfer

The International Centre For Nutritional Excellence (ICNE) Ltd. business transfer to Tangerine Holdings.

From 11th August 2017, ICNE Ltd. (company number 6377561) legally transferred business ownership into the Tangerine Holdings.

Tangerine Holdings is a group of companies in Lytham, Lancashire and the name behind VetPlus, Carr & Day & Martin, Agri-Lloyd and other well-known brands. It has a clear aim to be the recognised market leader in each sector of their business by providing super premium products and outstanding service.

Tangerine Holdings have made the acquisition of ICNE Ltd to further strengthen and develop the capabilities of ICNE as a testing facility within the raw material and nutraceutical industry.

The transfer of business will have no effect on our accounts, customer relations or quality management system. There will be no impact to our VMD GMP or UKAS ISO17025 accreditation and will continually work as we always do to ensure the highest quality of laboratory work to all our customers. Your point of contact, process of sample submission and all testing services will remain the same.

If you have any queries then please contact us on 01253 737 00 or info@icne.co.uk.

Regards,
Pam Mitchell
(Head of Quality for Tangerine Holdings)

Meet the ICNE team – Tom Kelsall (Analyst)

Tom Kelsall – Analyst

Tom Kelsall

Chemistry (MChem)

Tom has over 5 years’ experience in an ISO 17025 accredited laboratory.

After graduating from Bangor University, Wales in 2011, Tom joined a Global inspection and testing Company, Inspectorate International. Working within the metals and minerals division, Tom started as a Chemist, testing a variety of ores and concentrates through the application of fire assay methods. Within 3 years Tom progressed to a Team Leader position, combining technical analysis with a supervisory role, training and organising chemists within the laboratory. Tom also gained an NVQ in Business Improvement Techniques whilst at the company.

In 2016, Tom joined ICNE as an Analyst. Tom routinely carries out a wide range of analytical techniques on a variety of raw materials and finished products, creating reports and performing routine equipment calibrations.

Importance of QC Testing in the Herbal and Botanicals Industry.

A recent article in Nutraceuticals World, ‘Reviewing the state of the Herbs & Botanicals Market’, by Danielle Rose, focuses on topics such as understanding the market, new trends, challenges and quality control issues. In particular, this article looks into adulteration of raw materials and finished products in these markets and ways in which this can be controlled.

Raw materials testingThe dietary supplement industry regulations can vary from one country to the next. The lack of strict regulations could potentially lead to adulteration or mislabelling of products. As there is not one defined set of regulations to ensure harmony between different countries, self regulation is very important for quality control.

Due to competition in these markets being high, companies want to gain business by reducing the cost of their products whilst also increasing profit margins. This can sometimes lead companies to purchase the cheapest raw materials, which may be adulterated or ‘cut’ with other much cheaper materials. In many cases, the purchasers of the raw materials may not be aware that the purity of the raw materials may be compromised.

Testing is necessary to confirm to the industry and the consumer that you are, in fact, selling what you say you are’.

QC Testing The article encourages increased quality control measures with the aid of product testing. In being able to clearly state what you are selling, and by backing this up with the correct laboratory analysis, you will give consumers the confidence to trust your products and company and therefore win their business. In order to give complete and accurate information on the raw material, various types of analysis may need to be performed. It may be necessary to identify the product initially using ID tests such as Fourier transform infrared spectroscopy (FTIR), optical rotation, Thin Layer Chromatography (TLC) etc. This could be coupled with a purity test for the active component using high performance liquid chromatography (HPLC), titrations etc, whilst running the sample alongside a certified reference standard for traceability, and a placebo or blank (sample containing no analyte of interest) to prove the method has no interference from other components.

It is always good practice to have a flexible risk based approach on a testing regime for each raw material or finished product. Part of this testing regime can be to set up product specific specifications, which would include results that you should be expecting from the analysis of the raw material.

As well as being an excellent review of the herbs and botanicals market, this article strongly encourages laboratory testing in order to ensure the safety and quality of any raw material being purchased. If you require any raw material or finished product testing for your quality control procedures, then contact ICNE on 01253 737 009 or email us at info@icne.co.uk.

To see the full Nutraceuticals World article, click here

Meet the ICNE team – Lily Giles (Technical Sales Support)

Lily Giles – Technical Sales Support

Lily Giles

BSc (Hons) in Biomedical Science

Since graduating from Cardiff University, Lily has worked in customer facing roles in various industries. From 2013-2014 Lily worked as a New Product Development Assistant at Abergavenny Fine Foods Ltd, working with major retailers with the development of novel food products. This involved assisting with quality assurance standards and specifications, food regulations and NPD trials.

After this, Lily undertook a temporary role as Sales Completion Coordinator for a Property Development company, IDM properties LLP, London. This was a customer facing role, whereby she managed introductions of buyers to their new property. Lily organised all snagging of the properties, working closely with buyers, company directors, site managers and contractors.

In 2015, Lily took up a role at Steritouch Ltd as a Customer Service and Development Scientist. Lily managed projects and customer enquiries regarding incorporating silver, as an antimicrobial agent, into paints, plastic masterbatches and various other materials.

Lily started at ICNE Ltd at the start of 2016 as Technical Sales Support. She is able to combine her science degree and experience in customer facing and sales roles for this position. Lily works with all our customers, assisting them with all their enquiries, researching new methods and also attends trade shows to meet with new and existing customers. She also helps with business development, marketing, organising external laboratory testing, accounting, laboratory work and general day to day office tasks.

 

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