About Us

Manufactured to GMP Standards

Biosyntrx products are manufactured to GMP standards and above.    
 
Biosyntrx products adhere to all FDA, GMP guidelines for authenticity, potency, finished goods and documentation protocol.  The manufacturing facility is NSF certified and also audited by other independent outside agencies to certify and prove compliance with GMP guidelines and quality assurance practices. The Biosyntrx third party auditor is eurofins. 
 
Quality assurance checkpoints are built into the entire process, including multiple checks on raw material weight, proper grinding and mixing of raw material blend to assure uniform dispersion, multiple capsule weight checks throughout the encapsulation process, accurately filling the bottles with the proper number of capsules or softgels, and final testing of finished product for quality and label claims.
 
All these check- points guarantee that what's indicated on the label, matches the content of the bottle. A certificate of composition accompanies each product batch, which ensures that potency meets stated label claims of potency.

The state-of-the-art Biosyntrx manufacturing facility, Vitamin Research Products (VRP) in Carson City, Nevada maintains NSF registration. NSF is recognized around the globe for its scientific and technical expertise in the health and environmental sciences.

 

Since 1944, NSF International, an independent, not for profit global organization, has been committed to making the world a safer place for consumers. NSF works with regulators and companies to identify risk management solutions that best protect public health.

NSF supports the work of regulatory officials around the world, including standards development, product testing and certification, as well as onsite audits and inspections. NSF is accredited by the American National Standards Institute (ANSI), Occupational Safety and Health Administration (OSHA) and the Standards Council of Canada (SCC).

NSF registration is not a one-time activity. The registration  requires regular on-site inspections of the manufacturing facility.

The nutritional ingredients in Biosyntrx products are either non-GMO or comply with EU regulations for non-GMO labeling requirements. 


Our Manufacturing Flowchart
 
 
About NSF
 
Since 1944, NSF International, an independent, non-profit global organization, has been committed to making the world a safer place for consumers. NSF works with regulators and companies to identify risk management solutions that best protect public health.

NSF supports the work of regulatory officials around the world, including standards development, product testing and certification, as well as onsite audits and inspections. NSF is accredited by the American National Standards Institute (ANSI), Occupational Safety and Health Administration (OSHA) and the Standards Council of Canada (SCC).

NFS Certification is not a one-time activity. The certification requires regular on-site inspections of the manufacturing facility.

In the last decade, the dietary supplements industry has grown rapidly, while FDA funding for manufacturing site inspection has all but disappeared. This has led to outside certification of manufacturing facilities and products to ensure consumer confidence in nutritional supplement safety. Unfortunately, a number of for-profit companies have jumped on this market opportunity. A few of these companies “seal-certify” facilities and product ingredients for cash-up-front. This does not serve the supplement industry or the public well and these companies should be censured by the government.

Frequently Asked Regulatory Questions:

Does the Federal Government regulate dietary supplements?

The answer is a qualified yes, in spite of the public being told the government has no control over dietary supplements. Congress established the Dietary Supplement Health and Education Act (DSHEA) in 1994 to create a regulatory framework to address the safety and labeling of dietary supplements. Recent regulations have also been adopted to require manufacturers to observe good manufacturing practices (GMPs), including ingredient testing.

In contrast to prescription and over-the counter drugs, dietary supplements covered by the Act do not normally need approval from the Food and Drug Administration (FDA) prior to being marketed. The main exception is for products introducing a new dietary ingredient, where pre-market review for safety data and other information is required before the ingredient receives "generally recognized as safe" (GRAS) status.

Does the Federal Government regulate the advertising of dietary supplements?

Yes. The Federal Trade Commission (FTC) regulates advertising for supplements and most other products sold to consumers. Advertising and promotional materials received in the mail are subject to U.S. Postal Inspection Service regulations.

How do regulations for dietary supplements differ from those that cover prescription or over-the-counter drugs?

Dietary supplements are classified under the general category of food products, not drugs.

Because targeted pharmaceutical drugs have such serious side effects, they must undergo clinical studies to determine their effectiveness, safety, possible interactions with other drugs, and appropriate dosages. The FDA then reviews data to determine whether to authorize use of the drugs, or not.

Ellen Troyer,  with Spencer Thornton, MD and the Biosyntrx Staff.