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Protecting Public Health

Friday, December 28, 2007


The state-of-the-art Biosyntrx manufacturing facility, Vitamin Research Products (VRP) in Carson City, Nevada, was awarded NSF certification on December 19, 2007. NSF is recognized around the globe for its scientific and technical expertise in the health and environmental sciences.


Biosyntrx products are researched and developed by an in-house science staff with input from our esteemed scientific advisory board that includes "thought leaders" in ophthalmology, optometry, nutritional biochemistry, and molecular biology. The formulations and raw ingredient specifications are then presented to the outstanding team of scientists at VRP for current good manufacturing practice (cGMP) manufacturing and encapsulation.

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 censored 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, MT MA
Biosyntrx Chief Research Officer

PEARL

The side effects associated with dietary supplement are rarely any more serious than an upset stomach or headache. Therefore, the FDA does not consider it necessary to authorize nutritional products, particulary if the products include GRAS status ingredients, as do Biosyntrx formulations. However, the FDA does order the removal of a dietary supplement from the marketplace if they feel it is unsafe for consumers, or if outlandish health claims are being made.

The ingredients in all Biosyntrx eye health formulations are supported by large amounts or peer-reviewed published science, which is available under the "scientific rationale" web site link for each of our products.

The Biosyntrx founders, staff, and scientific advisory board wish our Friday Pearl readers and customers a safe and properous New Year.

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