Dietary Supplements and New Manufacturing Regulations

[Guest guest]

Dietary Supplements and New Manufacturing Regulations

 

Americans are realizing that their health is linked to the nutrients their

bodies demand, and sales of dietary supplements in the U.S. bears this out. In

2004, sales of U.S. dietary supplements reached $19.8 billion, according to the

Nutrition Business Journal.

 

Naturally, dietary supplement manufacturers have responded to the public’s

increasing enthusiasm for dietary supplements by increasing their supply. But

the dizzying abundance of products on the market today and the equally dizzying

variability in their quality has left consumers puzzled. How can we be assured

that we’re getting what we’re paying for, and that we’re getting a product

that’s actually beneficial to our health?

 

The need for improved quality control has been broadly recognized within the

industry and by federal regulators and has inspired dialogue and action

regarding quality assurance in the supplement industry.

 

Good Manufacturing Practices (GMPs) have been standard in the industry since

1994. They were designed as a means to assure the safety of a product and to

properly inform consumers by stating ingredients on the label. To do this, GMPs

address issues as raw materials quality, record-keeping of substances throughout

the manufacturing process, cleanliness and safety standards, manufacturing

personnel qualifications, in-house testing, production and process controls,

warehousing, and distribution.

 

In March 2003, the FDA published its proposed GMPs for dietary supplements,

which are still available for public comment. At the end of the comment period

the FDA will consider all comments and will publish the final regulations.

Companies will have approximately 1-3 years to comply, depending on the size of

the company. Just last November, the FDA announced its initiatives designed to

provide a strategy for improved quality standards. Once regulatory standards

have been established, some of the burden placed on practitioners and consumers

to determine the quality and safety of supplements will be alleviated.

 

To make the FDA GMPs more accessible, the NNFA collaborated with other industry

authorities to revise them, allowing for flexibility in how companies meet the

requirements. NSF International has done something similar, requiring product

testing, GMP inspections, and label evaluations. When companies meet the

requirements of the NNFA or NSFI, they may label their products with the

appropriate mark of certification.

 

It should be noted that while NNFA certification indicates a company has met

their standards, the absence of their certification does not necessarily imply a

product’s poor quality. Many responsible companies create their own GMPs that

may even be even more stringent than other organizations’. Some companies export

their products and are required to meet other stringent pharmaceutical GMPs that

exceed any in the U.S.

 

Currently it is difficult to know which companies are producing high quality

products without doing your own investigating. But until agreed upon standards

are established, the consumer is well-advised to establish a relationship with a

health care practitioner trained in nutrition and botanical medicine that can

help guide them to high quality dietary supplements appropriate for their

individual needs. Naturopathic physicians are well suited to play that role.

Learn more about how you can investigate product quality and ensure that you are

buying good quality products.

 

 

 

http://bastyrcenter.org/content/view/289/

 

 

 

Writer: Paul Dompe, ND

Sources: Nutrition Business Journal

2005

 

 

 

 

 

AIM Barleygreen

" Wisdom of the Past, Food of the Future "

 

http://www.geocities.com/mrsjoguest/Diets.html