Raw Materials: How We Source Them & Assure Their Quality
Adapted from an article by Dr Lelah, Ph.D., Technical Director for one of America’s foremost natural health and dietary supplement manufacturers - and one of Health & Herbs primary international manufacturing and supply parnters.
October 13, 2009
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| Dr Lelah inspecting organically grown crops |
We often receive inquiries on our raw materials from consumers. Consumers want assurances that the natural products they consume are pure and safe, especially in light of recent problems with food safety, both in the United States and globally. For example, many consumers are aware of the recent issue of adulteration of milk protein with melamine by certain manufacturers looking to squeeze every cent they can out of their milk protein raw materials. Naturally, these consumers are looking for assurances that they’re not the recipients of this “economic adulteration”, and rightfully so. These days it’s tougher than ever to know which manufacturers are ethical and have the consumer’s best interests at heart and which are only looking at the bottom line.
Our company are acutely aware of food quality and supply chain issues. As an ethical manufacturer, it’s our responsibility to safeguard the quality and safety of the products that we manufacture and sell, the products that both you and we consume. We take product safety very seriously, and in this article I’d like to give you an overview of the processes and procedures we use to ensure product safety. You deserve to have a certain comfort level with regard to the safety and purity of products we manufacture for our local brands and our international partners like the Radiance brand in New Zealand.
Let’s start with our ingredient/raw material supply. While we prefer to source our raw materials from local US vendors, this isn’t always possible or the best source of some ingredients, so we do source materials from all over the world. Most major countries are growers and/or producers of natural products, some of which are traditional products that have been produced for centuries. Some countries have applied millions of dollars into research and development of their traditional products, making them specialists and experts in producing the very best products. Examples include lavender from Europe, ginseng and ginkgo from China, Ayurvedic herbs and spices from India, cod liver oil from Norway, acai from Brazil, maca from Peru, whey protein from New Zealand and the U.S., red mineral algae from Ireland, mangosteen from Thailand, pycnogenol from France, lycopene from Israel, hoodia from South Africa, echinacea and saw palmetto from the U.S., and CoQ10 from Japan.
Other raw materials are not native to certain countries, but over time these countries have become the primary source of these ingredients. A prime example is stevia and United States Pharmacopeia (USP) quality vitamins from China. In fact, many of the ingredients that we source from China are produced under the strictest pharmaceutical standards and meet the highest purity standards required to be pharmaceutical grade. Keep in mind that no country produces raw materials or ingredients that are of uniformly good or bad quality.
We source ingredients from any country that provides a value source, that is to say, a high quality ingredient at a fair price. Our experience is that it’s not the country that counts, but rather the diligence in auditing and testing. This is what determines good quality, and ultimately leads to assurances of safety and purity. We utilize an extensive audit program. We obtain information on the quality of the production source from both the manufacturers themselves and third party auditors as well. In addition, for key products in our line, we personally audit the farms and/or production facilities to ensure the thoroughness of their quality control measures.
I’m an experienced auditor, and in the last few years I’ve personally audited facilities producing CoQ10, spirulina, psyllium, stevia, amino acids, fish oils, spices, herbal extracts, and many other raw materials. After audits, I write detailed reports that are included in the quality files we maintain in-house.
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| Looking through the microscope at organic spirulina algae |
Our diligence doesn’t stop here. One of the most important and expensive procedures we perform is in-house raw material and finished product testing in our state-of-the-art testing facilities here in the USA. We employ analytical, physical, sensory, and microbiological laboratories staffed by degreed technicians and Ph.D. scientists. We test our ingredients for identity, potency, purity, contamination, and adulteration. We have the capability to test for pathogens such as E. coli and salmonella; we have the capability to test for heavy metals such as lead and mercury; we have the capability to test for the potency of extracts and the purity of vitamins. All of our ingredients are subjected to testing. We’re aware of ingredients with a history of adulteration and/or contamination, and we put extra effort into testing these ingredients. This rigorous approach to testing is the cornerstone of our quality plan, and our quality commitment to you.
Another extremely important aspect of our quality assurance program is our adherence to GMP (Good Manufacturing Practice). We follow the new federal FDA dietary supplement GMPs (cGMPs), current food GMPs, and we are a certified GMP manufacturer by the Natural Products Association (NPA). We’re also certified Halal, and we’re certified as an organic manufacturer by Quality Assurance International (QAI), which also certifies every organic product that we produce. In Canada we’re site licensed by the Canadian Health Products Directorate (NHPD). We have a Hazard Analysis and Critical Control Points (HACCP) program in place, which is designed to identify potential hazards in our production procedures and put in place barriers to prevent contamination. We have a food safety plan in place that is designed to meet the FDA’s bioterrorism requirements, and we have an allergen program designed to reduce the potential for cross-contamination, including gluten contamination. We have a dedicated team of Quality Assurance and Quality Control specialists who monitor that we establish, follow and document all GMPs. In this way, we erect significant barriers to contamination and adulteration at our own production facilities.
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| Dr Lelah planting a tree to enhance water catchment at an organic psyllium farm |
Sourcing of our raw materials is more dependent on where quality materials are grown and produced, not public perception. Above and beyond this however, the quality and safety of our ingredients are more so dependent on our rigorous and robust auditing, testing, and manufacturing programs than anything else. In today’s unsure world, the safety of the food you ingest is largely dependent on the manufacturer. As an ethical manufacturer, we promise to do whatever is necessary to ensure the safety of our products.
About Dr Lelah
Dr. Lelah, Technical Director, has had a great impact on the company’s quality control and assurance efforts since joining our team in January 2004. Dr. Lelah came to us with over 20 years experience in research and development, quality, and manufacturing management in the fields of pharmaceuticals, healthcare, foods, packaging, and plastics. Dr. Lelah is an accomplished scientist, having earned his Ph.D. from the University of Wisconsin-Madison. After college he was the author of numerous research publications, and was awarded several patents in a number of scientific disciplines. From this research base he went on to develop many unique consumer and medical products. During this time Dr. Lelah gained a reputation as scientist who worked very hard to ensure that the products he developed were safe and worked as intended.
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