A 2014-15 investigation by the New York Attorney General found:Isn’t supplement quality regulated? How could this be?
Aside from questions attempting to discredit the analysis (highly processed, dissolved, filtered, and dried supplements may not test similarly to high quality botanical or whole foods ingredients), there is not a lot of guidance from the FDA regarding quality control.
The 1450 supplement manufacturers are largely in charge of setting their own quality assurance programs for some 85,000 products including nearly 1000 new products introduced each year.
Many “dietary supplements” and “energy supplements” contain ingredients that are regulated as drugs. In fact, this explains why 42% of all ER visits alleged to supplement products are actually weight loss products where the vendor’s formulation included regulated substances.
Whole foods supplements vs. Synthetic
There are critical differences between vitamins found in food and synthetic “vitamins” created in a lab.
Every vitamin is a biological mechanism, not a chemical.
—Dr. Royal Lee
Our bodies are not designed to assimilate or use synthetic chemicals or test-tube vitamins.
Vitamins work in concert with other nutrients and with each other—never alone.
What makes a quality supplement?
The manufacturer consistently ensures the supplement raw materials and final products:
- contains what it says it contains; authentic
- contains the amount the label says it contains, in the form it says it’s in; authentic
- does not have contaminants
- the manufacturer tests every lot of both the raw materials and final product to ensure all of the above
And the manufacturing plant and staff operate in such a way to protect dietary ingredients and dietary supplements from becoming adulterated during manufacturing, packaging, labeling, and holding:
- trained staff follow written, standard operating procedures
- trained staff use appropriate manufacturing equipment
- trained staff follow specific cleanliness procedures to prevent cross-contamination as well as foreign
- keep written records of all raw and final lots, manufacturing procedures, and other production records for at least 1 year after their expiration date (or 2 years after last distribution).
- keep a written record of each product complaint
Is it Pure?
Example: Nordic Naturals purchases fish oil from a raw material supplier. They carefully test for a panel of possible contaminants including lead, mercury, PCBs, dioxins, and other toxic chemicals. They also test for the concentrations of the different omega fats and vitamin D, key therapeutic components.
Example: A low-cost supplement company will accept the raw material supplier’s Certificate of Analysis but not further inspect on their own.
Which will you choose?
Most people use supplements long term; if they are contaminated, they could cause harm—minimally toxic chemicals or metals may counteract the benefits you seek.
Is it Real?
Example: MediHerb Bilberry has 25% anthocyanosides for eye health, circulation, repairs blood vessels, and is an anti-inflammatory and antioxidant. A low-cost supplement can be manipulated by blending in cheaper berries like black current or elderberries, or even amaranth dye.
Example: Protein powder. With so many on the market these days, it’s important to match the amino acid composition with your health needs. Are these spelled out on the label? Are the ingredients that create this combination spelled out on the label? Is it contaminant free?
Addition of melamine, a plastic-like agent, can artificially raise the apparent protein level—it can also cause serious health problems including death.
Which will you choose?
The “economically motivated” vendor or one who doesn’t test their raw material suppliers may be dangerous to your health.
Is it Effective?
A gazillion articles saying that compound X is good for symptom Y. But does that mean the supplement you buy is going to produce the result you want?
First of all, compound X has to be what your body needs in order to handle symptom Y. That’s why we find out with Nutrition Response Testing.
Let’s say that by using Nutrition Response Testing we find that licorice extract containing 12% glycyrrhizin (an active ingredient) will help with heartburn.
Well, is it effective? Aren’t there variations between raw materials?
Yes—in fact the “enemy line” pharmaceutical companies use against herbs and whole foods is that you don’t know how much of the active ingredient you are getting (note: plants, animals, and their natural compounds cannot be patented—only synthetic substances that are then labeled and regulated as drugs).
The amount of active ingredient can be tested in each batch using testing equipment that has been available for decades (for the chemists out there, HPLC is one example). A high-quality vendor ensures the same level of active ingredients in each lot.
The answer is on the supplement label details:
Scenario 1: The supplement product label states: licorice extract 200mg. It does not specify the concentration of the active ingredient. All the manufacturer has to do is ensure there is 200mg of licorice root in the tablet. Could be 200mg of old, dead root with zero activity.
Scenario 2: The licorice product label or insert states: licorice extract (or glycyrrhizin) content 12% 200mg. To have make this claim the manufacturer must prove the final product has BOTH an active ingredient concentration of 12% and a dry licorice root weight of 200mg. Most supplement manufacturers who include this level of detail will test the raw materials first and refuse subpar raw materials because you cannot make up for low starting quality.
Which will you choose?
How long will the supplement last on the store shelf, in my pantry… ?
As a rule, potency tests evaluate the amount of remaining, non-degraded, active ingredient over time. The expiration date is usually set at half the time before there is noticeably less activity. Many dietary supplement companies have no data to support their “best used by” or expiration date.
Inquiring into a new supplement company, it’s a good idea to ask:
- Are you conducing stability tests on your products?
- If so, what testing? Potency? Bacteria, yeast, mold contamination?
- If no, how do you verify the strength/potency of the product for the claimed shelf life?
How can a consumer know they are getting high quality supplements?
Price does not always reflect quality—but no vendor of cheap supplements can afford to have good quality control.
Great vendors (including local resources for whole foods), the ones we love to work with, make known their quality management and good manufacturing practices. They answer our questions and offer up opportunities for our inspection.
And nearly all of them have a professional line available only to practitioners with the training necessary to understand and use their products properly. These companies provide quality research data to their professionals—not just “tug at your emotions” marketing
Make sure to check whether your health professional is sufficiently expert in nutrition and supplements to not be duped by glamorous advertising. We’ve been helping people restore quality of life using whole foods and targeted, high quality supplements for decades.
We continue our education several times a year to keep up on the latest.