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Year End Report

Friday, December 27, 2013


The last Friday Pearl of 2013 assures our valued customers that Biosyntrx does not believe good is good enough for our valued customers. Our stated mission has always been  to produce the safest and most efficacious nutritional products available in the eye care sector.  
 
Our manufacturing partner, Vitamin Research Products (VRP), in Carson City, Nevada, is certified by the state of Nevada, as well as NSF, which is recognized around the globe for its scientific and technical expertise in the health and environmental sciences.  Our products are guaranteed to include the amount and type of nutrients stated on the label. 
 
Biosyntrx formula design and raw ingredient selections are meticulously researched by our in-house science staff in Colorado Springs, with input from members of our esteemed scientific advisory board, which includes thought leaders in nutritional biochemistry, molecular biology, ophthalmology and optometry. The formulations and raw ingredient specifications are then presented to the outstanding team of chemists at VRP for current good manufacturing practice (GMP) and encapsulation.
 
The NSF Good Manufacturing Practices certification reflects continued commitment to ensuring quality and satisfaction.  GMPs are regulatory requirements that provide guidelines for necessary processes, prodecures and documentation to assure the products produced have the identity, strength, composition, quality and purity they are represented to possess.
 
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. 



PEARL

We invite our readers to review the Biosyntrx Core Values.


A Reminder: IRS Publication 502

"You cannot include in medical expenses the cost of nutritional supplements, vitamins, herbal supplements, “natural medicines,” etc. unless they are recommended by a medical practitioner as treatment for a specific medical condition diagnosed by a physician. Otherwise, these items are taken to maintain your ordinary good health, and are not for medical care."

The cost of Biosyntrx formulations recommended by a medical practitioner to treat diagnosed eye disease qualify as a 2013 medical expense deduction. 

We wish for our customers and Friday Pearl readers a Healthy and Happy New Year. 


 

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