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Ensuring supply chain integrity before beginning supplement operations

Ensuring supply chain integrity before beginning supplement operations

In this remarkable age of international supply chains, instant transmissions of electronic information and voice communications, and the varied impositions of tariffs by different governments, the need for supply “country of origin” transparency has never been greater.

Recent statements from FDA Commissioner Scott Gottlieb, M.D., showed the agency believes it needs to step up its enforcement of the abuses of the dietary supplement industry that have been exposed in recent years. Concerns associated with imported goods remain, including the undisclosed presence of active pharmaceutical ingredients or their analogs, which have been identified by agency laboratories. The agency realizes to safeguard the consumers, it needs to step up enforcement of quality checks for imported materials.

One mechanism of this guardianship is the policing of new dietary ingredient (NDI) submissions by issuing timely acknowledgements of notification acceptance and better managing import alerts to customs and border officials to prevent adulteration, misbranding and potential harm to the consumer. This mandates transparency in the supply chain and honesty in disclosure documents.

Supply chain integrity rests squarely with the finished brand, which is tasked with the selection, handling, testing and processing of ingredients and components, as well as the composition, dose and shelf life of the finished product, whether it be a powder, liquid, tablet or capsule or in confectionery form. This elevation of responsibility was defined in statute with the passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA) and the subsequent imposition of the cGMP (current good manufacturing practice) requirements.

What remains a mystery is why almost half of the cGMP inspections conducted annually by FDA still result in either official or voluntary actions being taken by the firms inspected to correct deficiencies in some of the most basic components of a cGMP system, according to information obtained in a Freedom of Information Act (FOIA) request.

Supply chain transparency, or lack thereof, can contribute to significant problems with the agency and the products intended for commerce. Either producers of products in our industry are naïve, or they are willfully ignorant of their responsibilities. In certain circumstances, importers are willfully ignorant of what is in their products. Those that engage in such deception should be met with the full force of federal law, and the offending products should be subject to immediate seizure, no matter where or how the products are being sold in the United States.

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NutraCap Labs

About NutraCap Labs

OUR MISSION:
NutraCap Labs’ mission is to provide our customers with the highest quality products and an industry-best customer service experience. Based in Atlanta, GA, NutraCap Labs is a manufacturer of Nutraceuticals/Dietary Supplements and we are experiencing explosive growth. As a GMP compliant and an FDA registered company, we specialize in encapsulation manufacturing, sports nutrition and raw health powders, product formulation, brand design and distribution. Private Label manufacturing is the fastest growing sector of our business and our biggest strength due to the relationships we have built with our customers.

OUR GOAL:
Our goal at NutraCap Labs is to partner with our customers to create the best products possible through custom formulation, in-house label design and other services that we offer. Additionally, through our sister company, Active Sports Distribution, we market and sell some of the health and fitness industry’s most popular supplements to retail stores worldwide. With the Nutraceutical industry approaching $85 billion annually, we are excited to become a leader in this arena. Our experienced management team is committed to bringing ethics and professionalism to the forefront of the industry.

At Nutracap Labs we aim to lower what has always been a high barrier to entry into the dietary supplement industry. Our minimums start at 144 units per product and allows lower risk for two categories of customer. 1. Those who may be working with limited capital and cannot tolerate much risk. 2. Those who have the capital but are interested in testing the market before they scale their business
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