Trusted Ingredients and Good Manufacturing Practices?

I have taken vitamins and supplements with virtuous intentions and hopes of maintaining good health.  I got a big dose of reality when a friend who has been the model of health got rushed to the intensive care unit and the first question the doctors asked her was, “What supplements do you take and where do they come from?”

The American Botanical Council reports that total annual sales of herbal dietary supplements increased over 17.3% in 2020 and consumers spent over $11B on these products.  The Chicago Sun Times reports that there are “an estimated 90,000 products on the market, including vitamins, minerals, herbs or other botanicals, amino acids, probiotics, or other substances in pill, capsule, tablet, or liquid form. About half of American adults take at least one dietary supplement for health or wellness, or to fill nutrition gaps.”  Supplements are big business and consumers should beware.

The FDA does not test or regulate dietary supplements.  Although supplements often come in bottles and look like medicine, we cannot rely on the promises on the label.  I have asked some experts how we can be sure that the supplements we take are healthy for us and how we can determine where they come from.

The decision to take dietary supplements to enhance the nutrition you receive from a healthy diet is between you and your doctor.  When you choose supplements, you should look at where they are manufactured.  I am told that products manufactured in the US have the best chance of meeting the quality standards set by the FDA.  When you read labels, you will find that ingredients are sourced from around the world.  You will need a trusted manufacturer who will source safely.

Since January of 2021, Amazon has required its sellers of dietary supplements to provide a certificate of analysis (CoA) from an ISO/IEC 17025-accredited laboratory for each supplement; product images; and a letter of guarantee from the product manufacturer, including an assurance that the supplement is produced under FDA’s cGMPs (current good manufacturing practices).

The US Federal Government, FDA, sets quality standards and ‘good manufacturing practices’  for dietary supplements.  Three independent organizations test products and give their ‘seal of approval’.  They are US Pharmacopeia (USP), NSF International and Consumer Labs.

Good Manufacturing Practices.

 When a company puts a GMP label on their package, it claims to be using US Food and Drug Administration approved Good Manufacturing Practices. The FDA standards are in place to require that manufacturers of supplements (and drugs and some food) ensure that their products are safe, pure, and effective. GMP is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production. The GMP certification means that the manufacturer has registered with the FDA and is complying with the FDAs production standards. Compliance is mostly self-reported, but the FDA does inspections.  If you followed the Theranos story as I have, you may not rely entirely on companies to comply and self-report.

CGMP refers to the Current Good Manufacturing Practice regulations enforced by the FDA. CGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities.  CGMP from the FDA.

Three independent companies offer certifications that manufacturers have met FDA GMP and CGMP standards.  Manufacturers pay these independent companies to test their products and certify their quality.

This National Science Foundation (NSF) helps set standards for manufacturers, regulators, and consumers.  They test products and offer certification programs for food and dietary supplements. The NSF mark is one assurance that a product has been independently tested and reviewed and that you can trust the claims made on the label. NSF Certification

The United States Pharmacopeial Convention (USP) Dietary Supplement Verification provides consumers with an independent verification of the accuracy of the supplement label and the standards with which it is produced. Costco and NatureMade are two of their customers.  A doctor friend, who studies health and nutrition suggests that the USP review process can be trusted.

“Seeing the USP Verified Mark on a dietary supplement label indicates that the product:

• Contains the ingredients listed on the label, in the declared potency and amounts. Tests have shown that contents of some supplements don’t match the label and some contain significantly less or more than the claimed amount of key ingredients. USP Dietary Supplement Verification helps assure customers that they are getting the value they expect from a product they are purchasing.
• Does not contain harmful levels of specified contaminants. Some supplements have been shown to contain harmful levels of certain heavy metals (e.g., lead and mercury), microbes, pesticides, or other contaminants. At specific levels these contaminants can pose serious risks to one’s health.
• Will break down and release into the body within a specified amount of time. If a supplement does not break down properly to allow its ingredients to be available for absorption in the body, the consumer will not get the full benefit of its contents. USP Dietary Supplement Verification tests products against performance standards.
• Has been made according to FDA current Good Manufacturing Practices using sanitary and well-controlled procedures. Assurance of safe, sanitary, well-controlled, and well-documented manufacturing and monitoring processes indicates that a supplement manufacturer is quality-conscious, and that the supplement will be manufactured with consistent quality from batch to batch.”  ~The United States Pharmacopeial Convention

Consumer Lab offers product reviews and comparisons on a large number of dietary supplements and vitamins.  They also test and review health products like masks and oximeters. You will need to join for $4.50 a month in order to get their information.

The CL Seal of Approval means…

We need to pay attention to what we are putting into our bodies.  It is tempting to grow some of the herbs in supplements ourselves.  The American Botanical Council offers an herbal library  with a database of healthy ingredients.  I was interested in their virtual tours of gardens (free) including a first aid garden, a children’s garden and antioxidant garden.  They have an extensive online guide to herbal products, but it requires a $150 subscription.

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