NatureRich Responds to FDA and Health Canada Notices
From the beginning, the mission of NatureRich is to offer high quality, natural products. The company’s foremost concern is, and always will be, the well-being of its customers.
When NatureRich (formerly The Master’s Miracle) started; the soaps, skin moisturizer, gel, and Neutralizer were manufactured by an outside source – Tedco, Inc. in Louisiana, which was founded by Clayton Tedeton (ie; Miracle II). When Tedco failed to improve their manufacturing practices and product quality to meet NatureRich’s standards and began selling direct to their customers, NatureRich was forced to find an alternative source. In April of 2004, NatureRich began to manufacture its own line of natural products.
FDA INSPECTED
The FDA has inspected NatureRich’s Maple Grove food production manufacturing facility on several occasions. The company has been implementing the FDA recommended changes and reports their progress to them on a monthly basis.
The FDA issued a notice regarding the Fortified Mineral Neutralizer. The notice revealed bacterial contamination and aerobic plate counts through FDA analysis (including Pseudomonas aeruginosa). This product sample was taken from a field sample, not a product at the warehouse. The Neutralizer is a natural product it does not contain a preservative. The tested Neutralizer product was manufactured in December ’04 and January ’05. NatureRich has had no such occurrence in any Neutralizer prior to or since then.
The FDA did not require NatureRich to issue a recall on the Fortified Mineral Neutralizer. The FDA did not view the product as a health risk, as long as it was not used in the eyes. FDA regulations require that all products need to be sterile for use in the eyes. NatureRich conducted a recall of any “marketing materials” that stated that the Neutralizer could be used in the eyes.
FDA also conducted an analysis of a sample of the NatureRich Skin Moisturizer. This analysis revealed bacterial contamination. The tested sample was taken from one rejected batch of skin moisturizer that was inadvertently shipped. NatureRich has since corrected their inventory system to prevent this from ever happening in the future. The shipped items from that batch were also recalled. There has been no such occurrence prior to or since then.
HEALTH CANADA NOTICE
NatureRich was sending product internationally to Canada. In May of 2005, Health Canada, a similar government agency to the FDA, sent NatureRich a notice indicating that during testing of the Neutralizer taken from the field, they found it to be contaminated. This notice was also issued to the public.
Unfortunately, an Escherichia coli (E-coli) contamination found in Tedco’s Miracle II product was mentioned within in the same Canada Health warning letter. NatureRich had no association with Miracle II/Tedco at that time. This may have created confusion to their consumers and NatureRich would like to reiterate that their products have not been associated with Miracle II since April of 2004.
All of the Neutralizer products manufactured at the Maple Grove plant are tested in triplicate for microbial contamination at a prominent outside testing facility. Products cannot be shipped until they have passed this thorough testing. There has been no such occurrence prior to or since Health Canada did the testing.
MARKETING CLAIMS
Many of the FDA recommended changes to NatureRich were in regards to the labeling and marketing claims only. For example, the Neutralizer cannot be labeled as a cosmetic (for bathing use) and a dietary supplement (for drinking) on the same label or bottle. NatureRich has revised all their labeling to comply with current regulation and even released a new product called Energizing Mineral Bath. This product replaces the Neutralizer for bathing use – and doesn’t need refrigeration since a natural preservative could be added: grapefruit seed extract. Other changes included