Quality Standards

Skip Lot Testing Misses the Mark

by Beth Baldwin-lien, ND
For all other information about potential contaminants in a supplement, the manufacturer is currently allowed to rely on a certificate of analysis from the raw material vendor. The supplement manufacturer does bear the responsibility for verifying the authenticity of the certificate of analysis, but vendors may be “qualified” using a vendor qualification process, after which the manufacturer may perform skip lot testing to periodically confirm this “qualification.”

Who Makes These Dietary Supplements, Anyway?

by Lise Alschuler, ND, FABNO
While we all have our favorite brands of dietary supplements, the brands may not be as distinct as we think from a manufacturing perspective. Dietary supplement manufacturing spans a wide spectrum. One of the most common manufacturing methods is for a finished product company to contract the manufacturing to another entity.

Recalls of Dietary Supplements

by Lise Alschuler, ND, FABNO
Several of my colleagues and I had an interesting conversation the other day about product recalls. As we traced through the FDA requirements for product recalls, we realized that many practitioners may be unaware of their role in the process. As a result, many may not have practices in place to efficiently fulfill recall obligations. In the absence of these business practices, patients' safety could be jeopardized.

Ensuring Probiotic Quality

by Lise Alschuler, ND, FABNO
Probiotics are a very significant category of dietary supplements, and integrative practitioners frequently recommend them. Their popularity has fueled significant growth of this segment of natural products. However, as we all know, growth is not always good. In the case of probiotics, this booming growth has introduced a variety of products into the market that span the quality continuum from excellent to harmful.

The Truth About Medical Foods

by Lise Alschuler, ND, FABNO
Have you ever looked at a label and noticed the term medical food? Although medical foods have been around for decades, many healthcare professionals may not recognize this term, as it was not part of our standard medical training. As these therapeutic medical foods become more and more popular it is our responsibility as healthcare professionals to understand what they are, their significance, and how they compare to functional foods.

The World in a Capsule

by Lise Alschuler, ND, FABNO
The globalization of the food and ingredient supply chain is quite significant. It is not unheard of to have ingredients sourced from Asia, the Middle East, Europe, and North America all within one product. Even relatively simple products with one active ingredient can have inactive ingredients sourced from all over the planet.

The Who, What, When, Where and Why of Serious Adverse Event Reporting

by Lise Alschuler, ND, FABNO
One of the key aspects of dietary supplement regulations is the opportunity for consumers, healthcare providers, and manufacturers to report serious adverse events. The Dietary Supplement and Nonprescription Drug Consumer Protection Act took effect in 2007. The intention of this act is to provide a way to identify potentially harmful supplements and prevent harm to future consumers. Adverse event reporting is a cornerstone in the safe use of dietary supplements.

On-site Audits

by Lise Alschuler, ND, FABNO
One of the most revealing aspects of evaluating a dietary supplement manufacturer is an onsite audit. There is nothing quite like seeing the production processes with your own eyes to determine the quality of the manufacturer.

Change is Good, Right?

by Lise Alschuler, ND, FABNO
The dietary supplement world is awaiting some critical guidance regarding new dietary ingredients from the FDA due to arrive by the end of June 2011. In anticipation of this guidance, chatter in the industry has increased, and this has even made the news.

Radiation in Dietary Supplements

by Lise Alschuler, ND, FABNO
The potential health implications caused by the nuclear disaster in Japan may extend beyond Japanese citizens. The wind and water currents have carried radioactive materials to many parts of the world. Furthermore, concerns are arising regarding consumable goods exported from Japan. Included in this category are dietary supplement ingredients and their finished products.

The Winding, Global Path of Dietary Supplements

by Lise Alschuler, ND, FABNO
One of the pleasures of winter in New England is its revelation of the wonder of my dog's nose. During our walks at any other time of year, with her nose pressed to the ground, it appears as if my dog is enthusiastically, albeit randomly, on the hunt for something she hasn't found yet. However, in the winter, those apparently random sniffs are transformed before my eyes into a precise tracing of an animal's trail. With the help of tracks left in the snow, I can now see the trail that my dog's nose is leading her along. It amazes me how accurate she is in staying on the trail, and I know that, with enough time, she could easily follow the trail all the way to its source.

Beyond Testing: Ensuring Supplement Quality

by Lise Alschuler, ND, FABNO
This issue of the "Natural Medicine Journal," we debut a column on quality in which various aspects of quality assurance in the dietary supplement industry will be addressed. It will be a practitioner's journey into the world of dietary supplement manufacturing. As we travel, we will learn the route, appreciate the landscape, and take some keepsakes back into our clinical practices.