Supplement contract manufacturers are critical in the supplement industry as evidenced by the regulatory actions taken over the last decade. This decade of increased awareness for the element that best helps maintain a robust industry has dramatically changed the landscape. The implementation and enforcement of GMPs (good manufacturing practices) for dietary supplements is the impetus…
Supply chain management involves the careful oversight and organized handling of a product’s development flow, from purchase and receipt of the raw materials to its manufacturing, testing, label development, labeling, packaging and distribution processes with the various service providers in each segment of the supply chain. Supply chain management is crucial for contract manufacturer selection…
Patent filings directed to sports nutrition continue to generally grow year over year. The trend is particularly pronounced on a global scale. The increase in patent filings (through 2016) of sports nutrition products has been occurring outside the United States, with a large portion of filings in China. Brazil and Russia, which are not usually…
FDA investigators who inspect dietary supplement manufacturing facilities for compliance with cGMPs (current good manufacturing practices) are still often finding the same deficiencies more than a decade after the regulations were adopted. In fiscal year 2018 (FY18), 75 inspections—or about 24 percent of firms that received a Form 483 inspection report for “observations,” or alleged…
Over the past several years, the Food and Drug Administration (FDA) has focused its attention on compliance issues related to the dietary supplement industry, generally, and on current good manufacturing practices (cGMPs), in particular. Indeed, we have seen an increase in the issuance of 483s and warning letters to Private Label Distributors (PLD) for failing…