Presentation Transcript

1. NOW InternationalQuality

   Michael Lelah, Ph.D. Technical Director May 2010, Geneva
2. Topics Overview of NOW Quality How we are addressing specific product issues of concern to you How can we can better meet your needs?
3. Family-OwnedBusiness Personal commitment to health and wellness We consume our own products Quality is of paramount importance to us We choose to run our business this way
4. Quality Topics Products That Work Focus On Ingredients Manufacturing Practices Accurate Labeling
5. Our mission is to provide value in products and services that empower people to lead healthier lives. Our fundamental proposition is that our Products Work.
6. Products That Work Contemporary products Effective potencies – single ingredient products and formulas Synergistic ingredients Claims supported by scientific data and clinical studies Advanced & innovative formulas Formulated by professionals
7. In-House Clinical Studies M.D. study director Blinded studies Completed studies include – pain, cholesterol, antiperspirant Ongoing study - sleep
8. University Studies Completed & Ongoing NOW SAMe vs. Celebrex (Joint Pain) NOW Red Yeast Rice (Cholesterol Reduction) NOW Vitamin C (Asthma and Exercise) NOW Whey vs. Soy Protein (Exercise) NOW Ojibwa Tea Extract (Quality of Life) NOW Allibiotic (Bacterial) NOW Pain Actin (Joint Pain) NOW L-Citrulline (Vascular Disease) NOW Alpha-Sorb C (Vitamin C Absorption) NOW Astragalus (Quality of Life)
9. Scientific Formulation Staff 1 M.D. 4 Ph.D.s – chemistry, food science, microbiology, chemical engineering 2 adjunct Ph.D.s – microbiology, chemistry 5 M.S. – chemistry, biochemistry, food science 3 Nutritionists (C.N., C.C.N.)
10. Quality Topics Products That Work Focus on Ingredients Manufacturing Practices Accurate Labeling
11. Product Quality Starts With Quality Ingredients
12. Our Approach To Ingredients We search for the Best ingredients – quality and price We choose Natural ingredients We look for the Science behind the ingredient We set Specifications for identity, potency, safety We find the best Sources We Test Ingredient suppliers are notoriously the weakest part of the supply chain – look for alternative suppliers
13. Specifications
14. Testing In State-of-the-Art Labs Industry-leading laboratories Fully equipped for both QC and special testing Professional staff Strong background in chemistry and microbiology
15. Every Ingredient Is Tested for Identity Chemical Testing
16. Identifying Purity CoQ10 Ginkgo Biloba
17. Potency Testing Scientific expertise in developing methods Professional analytical chemistry staff Over 100 methods Many methods published Some methods have become Industry Standards
18. We Create The Highest Standards
19. Glucosamine and Chondroitin Analyses Chondroitin Glucosamine AOAC Method AOAC Official Method
20. NOW’s Vitamin C Method is More Accurate USP Standard Titration Method can’t distinguish between oxidized and non-oxidized forms
21. Safety Testing Bacteria, pathogens Heavy metals Pesticides Adulteration Contamination
22. Contamination Testing Heavy metals Micro Irradiation PCBs Pesticides Solvent residues BAP
23. Micro Safe Bacteria Yeast and Molds Pathogens Mycotoxins
24. Metals Testing
25. Adulteration Testing Melamine Sudan Red dyes Steroids Hormones Weight loss drugs Erectile dysfunction drugs Different botanical species
26. No Melamine in Rice Protein
27. FTIR Screening
28. Degradants Peak E in Tryptophan Peak X in 5-HTP and Melatonin
29. L-TryptophanTested for Safety
30. Stability Testing BEST PRACTICES – SHELF LIFE Alcohol Liquid extracts 5+ yrs Minerals 5+ yrs Herbal extracts 2 – 4 yrs Capsules, Tablets, Softgels 2 – 3 yrs Formulated liquids 1.5 – 2 yrs Probiotics 1.5 – 2 yrs
31. Supply Chain Safety Buy Local Buy Global
32. Auditing Our Supply
33. Our philosophy – organic is better Focus on products taken in large quantities Identity-Preserved certifications To NOP standards Watch for microbial contamination Organic/Non-GMO Certification
34. Ingredients We Use and Don’t Use “At NOW Foods, we sell natural and nature-identical products – natural supplements, foods, and health & beauty products. We differentiate ourselves from the mass market, where synthetics are rampant. We also distinguish ourselves from many who claim to sell natural products, but whose products are far less than natural.” Item # 8912
35. Quality Topics Our Products Work Focus on Ingredients Manufacturing Practices Accurate Labeling
36. We Care Consistent manufacturing practices Hygiene and cleanliness Process control to minimize errors Corrective actions and continuous improvement
37. GoodManufacturing Practices
38. FDA cGMP Compliance 2000 Natural Products Association (NNFA) GMP Certification 2008 NPA Certification continues June 2009 – new FDA cGMPs
39. Canadian Compliance NOW Foods Site License in compliance with Canadian NHPD requirements NOW products manufactured in Canada meet NHPD GMP requirements
40. The GMP Process
41. Dietary Supplement cGMPs Covers Personnel, Plant, Grounds, Equipment, Utensils, Process Controls, Quality Control, Components, Labeling, Packaging, Batch Records, Laboratory Operations, Manufacturing Operations, Packaging and Labeling Operations, Holding and Distribution, returns, Complaints, Recordkeeping FDA Inspection of our Facility March 2010 4 day inspection Covered all aspects of cGMPs Inspector comments – clean facility, we understand the regulations, cooperative, responsive FDA issued 2 observations related to documentation of complaints and to batch processing. Both issues addressed.
42. Testing from Start to Finish In-Process Pre-Shipment Sample Incoming Lot Identity, Potency, Safety, Organoleptic Micro, Potency Physical Retained Samples Finished Product Potency, Micro, Organoleptic Potency, Micro, Physical, Disintegration Organoleptic
43. Allergen Control A Top Priority Peanut-free processing facility Cross-contamination prevention procedures in place Allergen identification during processing Cross-contamination testing
44. Freshness Control Anti-Oxygen Packets Desiccant Packs Nitrogen Flushing Barrier Containers Shelf-Life Testing 275+ Products With Ageless
45. Quality Topics Our Products Work Focus on Ingredients Manufacturing Practices Accurate Labeling
46. Labeling - The PrimaryPoint of Reference For Quality For Retailers & Consumers
47. Accurate Labeling Full Disclosure Allergen “Free Of” Info Protein Free Gluten Free GMO Free Serving Size and Usage Best By date Freshness Control Cautions/Interactions
48. Probiotic Potencies at Time of Manufacture AND at Expiration Date
49. Quality Topics Our Products Work Focus on Ingredients Manufacturing practices Accurate Labeling
50. Product Information Services Live call answering Nutritionists have access to detailed product information 800 e-mails a month Priority for retailers; support for consumers Specialized training through NOW University
51. Slide on taking pills
52. Product Related Issues Irradiation Heavy metals Chloramphenicol PAH/BAP Micro GMOs Ingredients not allowed Expiration dating Proprietary ingredients
53. Irradiation No irradiation standard – EU and US NOW’s policy – no irradiation – on PO T&C Testing by PPSL and TLD Focus on high intermediate (3000 – 5000 counts) and positives Some botanicals and minerals naturally fluorescence Effect of light on natural fluorescence Takes time to address
54. Examples Water Out – found the problem to be Dandelion and Goldenrod Sourced new herbs
55. Nightime herbs Problem was passion flower Worked with vendor – ingredient now not irradiated
56. Kelp Tabs Irradiation and heavy metals (Arsenic) Finding that ingredients not irradiated have high Arsenic and vice versa New product from France going through testing
57. Goldenseal Tested high for irradiation Worked with vendor who confirms not irradiated Vendor observed light effect Study at NOW confirmed vendor observation Sampling and testing now done in the dark
58. Bentonite Irradiation and heavy metals (lead) NOW does not sell this product for internal consumption Labeled in US as a “chemical”, topical use Vendors won’t sell us product not irradiated – red flag for micro Looking for other sources
59. Chitosan High radiation Investigation – false positives due to high silicates content Vendor has provided no irradiation statement
60. Psyllium Husk Caps Cannot test finished product because of matrix interference Vendor no–irradiation certificate
61. Heavy Metals Testing done in-house on all ingredients Significant investment in equipment and chemists Standards difference between US and EU EU based on ppm ingredient US based on mcg/day
62. Problem Ingredients/products Kelp (arsenic) Chondroitin (lead) Bentonite (lead, Cadmium)
63. Chloroamphenicol Used on bee products Illegal in US and EU Different tests used in EU and US lead to different “no detection” limits – cause early confusion We’re now using 300 ng/kg EU standard, tested by ECCA Labs, Belgium (ELIZA method) Royal Jelly – OK Bee pollen granules – looking to source alternatives – very expensive Propolis - ongoing
64. PAH/PAB Polyaromatic Hydrocarbons. Benzo(a)pyrene is the marker EU limits for oils, fats 2 mcg/kg Dutch regs – 2 mcg/kg food supplements, 10 mcg/k herbal preparations ?? Not a major problem, but could be for some herbs Feverfew and Valarian – looking to source alternatives
65. Micro Sophisticated in-house micro lab Generally issues are taken care off at ingredient stage Issue with white rice flour – used as a natural filler in many capsules, tablets Found a very low micro source – have converted all supplements
66. GMOs Significant differences in approach between EU and US Products labeled non-GMO in US – are IP (identity preserved) Many other products not labeled GMO free because of lack of IP We buy from the most natural sources – chance of getting GMO ingredients low Looking at testing for confirmation – focus on Round-Up Ready corn and soy testing
67. Ingredients Not Allowed Custom formulations very expensive and time consuming – try to harmonize Vanadium – also not allowed in Canada – changing formulations Forms – ge Boron, amino acid chelates, etc European Multi 1 – create special formula to meet EU requirements
68. Expiration dating Expiration dating based on data Shelf life studies Accelerated testing Retained sample testing Vendor data Short dated products problems for all Looking at ways to extend shelf life using Ageless, different packaging, encapsulation
69. Proprietary Ingredients Historically, vendors have withheld information in order to protect copying New cGMPs in the US, and most countries do not allow this Focus on getting vendors to disclose and list all ingredients and in order
70. Stevia NOW enzyme treated Stevia Improved taste profile – reduced bitter aftertaste US GRAS April 2010 Presentation at SteviaWorld, Geneva, May 2010 Evaluating against JECFA standards
71. Hope this leaves you with: Better understanding of our commitment to quality Our commitment to meeting your needs The challenges facing us in meeting your needs What else are we not doing?