After a long period of working with the US FDA, we have finally achieved official notification of compliance.
This means we are now able to resume distribution of all products within the United States with the exception of our probiotics and Bio Silver. We send every batch of our supplements away for external laboratory testing to verify the quality of the product. Unfortunately, the cost of the testing on probiotic products is cost prohibitive at present. However, this is something we are working on and we will notify our American customers once we have achieved a resolution.
As one of very few UK supplement manufacturers to be inspected by the FDA, we are now one of the only UK supplement manufacturers legally able to supply dietary supplements to the United States.
As I’m sure you’re aware, all supplements supplied to the US must conform to Code of Federal Regulations Title 21, Part 111(often abbreviated to 21 CFR 111). If supplements are not compliant with 21 CFR 111, it is not legal to supply them within the United States.
Metabolics is in compliance with the cGMP regulation (21 CFR, Part 111), established for the food/dietary supplement industry and regulated and inspected by the United States Food and Drug Administration (FDA).
Metabolics also follows the IADSA (The International Alliance of Dietary/Food Supplement Associations) Global guidelines to GMP for food/dietary supplements.
These regulations ensure the identity, purity, strength, composition and quality of food/dietary supplements. They regulate virtually every aspect of manufacturing, including facility design and maintenance, raw material specification and control, supplier validation, product design and testing, and more.
The GMP regulations are set in place to guarantee to consumers that strength and potency claims and ingredients statements on Ingredient/’Supplement Facts label panels are accurate. GMP also makes food/dietary supplement manufacturers responsible for reporting product quality problems.
Be aware, there are manufacturers, both foreign and domestic, who falsely claim to be “FDA approved” in order to deceive their customers about the quality of their products.
If you have any suspicions about whether or not a supplement manufacturer has been inspected by the FDA, you can check whether or not they appear on the FDA’s list of inspected facilities by clicking here.
Thank you once again for your continued patience and support during this period of organisational developments, we hope it gives you peace of mind that the supplements you order from Metabolics are of the highest quality, and legal within the USA.
Metabolics is registered with the U.S Food and Drug Administration pursuant to the Federal Food Drug and Cosmetic Act, as amended by the Bioterrorism Act of 2002 and the FDA Food Safety Modernization Act.
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