Biosyntrx
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Friday Pearls
New Years Eve Report
December 31, 2010
We will use the last Friday Pearl of 2010 to assure our valued customers that Biosyntrx takes care to produce safe and efficacious nutritional products guaranteed
to include the amount and type of nutrients stated on the label.
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.
Biosyntrx formula design and raw ingredient
selections are meticulously researched by our in-house science staff in
Colorado Springs, with input from our esteemed scientific advisory
board, which 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 chemists at VRP for current good manufacturing practice (GMP)
manufacturing 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, MT MA
Biosyntrx CEO
Biosyntrx CEO
Chief Research Officer
PEARL
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 2010 medical expense deduction.
We wish for our customers and Friday Pearl readers a healthy and Happy New Year.
Crestpoint Management, LTD instrument announcement:
Round Handle Fujimoto CCC Guide - Ø5.6mm 9-518-2R
Round Handle Fujimoto CCC Guide - Ø5.6mm 9-518-2R
