Last week news took hold on the contamination and adulteration of herbal products.
According to this study, Canadian researchers looked at numerous bottles from 12 companies and found that what was on the label was different than what was about 30% of bottles tested. Many of the herbal products were adulterated with fillers such as wheat, rice and soybeans.
My Take On This
Unlike the popular belief, the dietary supplement industry is regulated by the FDA. In 1994 the Dietary Supplement Health and Education Act (DSHEA) and in 2006 by the Dietary Supplement and Nonprescription Drug Consumer Protection were developed to regulate the dietary supplement industry. The confusion is that dietary supplements are not regulated like drugs but regulated like food.
The rub is that there is no premarket approval for supplement production. Another words, there is an honor system in place that allows supplement manufacturers to produce products until proven unsafe.
How does DSHEA work?
DSHEA placed dietary supplements as a category of food and created a specific definition for dietary supplements. Further, DSHEA provided FDA with additional enforcement authority, including the ability to remove a dietary supplement from the market the agency considers unsafe.
It’s also the law for companies to abide by Good Manufacturing Practices (GMPs) rules enforce the following:
• the design and construction of physical plants that facilitate maintenance, cleaning
• proper manufacturing operations
• quality control procedures
• testing final product or incoming and in-process materials
• handling consumer complaints, and
• maintaining records.
More on FDA regulations with dietary supplements GO HERE to the Council for Responsible Nutrition (CRN)
Again, the FDA does not have the resources to closely oversee over 1000 manufacturing facilities to assure that GMP rules are followed. So there are some companies that intentionally or unintentionally do not follow the rules – and no one will know it until a dietary supplement proves to be unsafe and then it’s tested.
So clearly this is a problem.
People are buying dietary supplements and not always getting in the bottle what is written on the label.
DNA barcoding has been questioned by experts in the botanical medicine field as not being an accurate method of measuring adulteration in herbal supplements – CLICK HERE for more on this from the American Botanical Council (ABC).
What should you do?
If your healthcare practitioner is versed in the field (Naturopathic doctor or Integrative MD) no need to worry. Such doctors typically have access to the highest quality of dietary supplements.
For example the nutritional supplement companies I use for patients are from companies with very high manufacturing standards that go beyond what the FDA requires. 90% of dietary supplements I use are from Designs for Health (DFH) or Douglas Labs (DL).
How DFH does things
In addition to strictly following GMP laws, DFH seeks third party company , namely the National Sanitary Foundation (NSF) who frequently visit manufacturing facilities to assure the highest level of manufacturing practices.
Every DFH dietary supplement:
• Is evaluated and monitored for potential contaminants such as heavy metals, pesticides, and microbiological organisms
• Is analyzed to confirm the quantity of all dietary ingredients, thereby ensuring the consistency and accuracy of our label claims
• Methods to test for yeast and mold counts and pathogen screens for e.coli, staph and salmonella
• Complete analytical screening of all raw materials and finished goods
◦ Independent third party residual solvent screens
◦ Potency verifications and pesticides tested at the Designs for Health analytical lab via High Performance Liquid Chromatography (HPLC) and Gas Chromatography (GC)
◦ Independent third party heavy metals analysis via Inductively coupled plasma mass spectrometry (ICP-MS)
How DL does things
Douglas Laboratories has similar manufacturing standards to DFH including ISO-9001 Certification and ISO-17025 Accreditation for in-house laboratories as well as NSF Certification. DL are FDA compliant and have rigid procedures and manufacturing practices that are designed to monitor and verify quality throughout every step of the production process.
Their in-house laboratories test and monitor for quality and safety from the raw materials as they enter our facility through to finished goods. Materials are kept in quarantine until they have passed testing specifications. Materials and formulas are tested for potency, purity, disintegration/bioavailability and stability. Additionally, this year ConsumerLab.com rated DL #1 Rated Healthcare Practitioner Brand Based on Consumer Satisfaction.
Doggy Bag Message
The study by the BMC should not deter consumers from consuming beneficial botanicals that have minimal to no side effects and can be very effective. There are over 1000 dietary manufacturing supplement companies and for sure, not all have the same manufacturing practices mentioned above – but most do – especially practitioner brands. A fabulous resource for consumers , for about $36 a year, that randomly selects dietary supplements and independently test them for purity is ConsumerLab.com.
I hope this clears up most of the confusion.
Let me know if you have any questions