HERB & SUPPLEMENT QUALITY

The first step in treating Environmental Illness is avoidance, which involves identifying and minimizing contact with environmental toxicants. How do you know the herbs and supplements you prescribe do not have concerning levels of metals, pesticides, solvents and other toxic compounds?

• Assessment and Level of Concern
• What are the Potential Risks
  • Which chemicals are the biggest concern and why?
  • Which type of products have greater risk?
• What current regulations are in place to protect us?
• What do 3rd party certifications mean? Which are the best?
• How do I read a Certificate of Analysis
• Why is it essential patients buy from a verified source - and NOT Amazon?

Assessment and Level of Concern

As with all other potential environmental toxicant exposures, acceptable levels of risk have been established for herbs and supplements due to known issues of ubiquitous low-level chemical contamination. However, regulatory bodies, public watchdogs and experts in the field often disagree on specific levels of concern for health impacts. Additionally, the industry itself often sets and meets quality standards. Understanding the various standards and certifications for herbs and supplements can help you choose the cleanest products.

What are the potential risks?

Contamination, adulteration, fraud, and piracy of herbs and supplements are common. Contamination can be the result of raw materials being grown in or harvested from toxic environments, during the manufacturing process, and/or from packaging, while adulteration, fraud, and piracy occur for financial gain.

Which chemicals are the biggest concern and why?

Metals bioconcentrate in many plants and can be found in high levels in herbal products and superfoods. Since even small amounts of metals can be dangerous, they are the most concerning.

Pesticide contamination is undoubtedly common. However, the amount of pesticides in supplements is likely minimal compared to exposure from conventionally grown food due to a lower volume consumed. Exceptions are higher volumes of superfoods, powders, and herbal teas.

Solvents are used to manufacture herbal tinctures and some essential oils. While ethanol alcohol extraction is considered safe, heptane may be a component in some ethanol products, while toxic solvents such as hexane may be substituted.

Plastics can become part of the finished product during the manufacturing and packaging processes and can also be absorbed from the soil by plants.

Which types of products have greater risk?

Herbs have the potential to bioaccumulate metals, can be exposed to pesticides and solvents, and are prone to a variety of fraudulent practices that may increase toxicity. Stay tuned for a NAEM handout on herbs that are more vulnerable to contamination (contamination and fraud).

Fish and algae oil may be contaminated with mercury and POPs such as chlorinated compounds and PFAS due to bioaccumulation (contamination).

Protein powder with added melanin to increase nitrogen so that product will appear to have more protein (fraud).

Capsules may contain phthalates and lead (packaging). 

Regulations

The EPA sets Maximum Allowable Limits (MALs) of a large list of toxicants for foods and supplements which are reviewed and updated daily. MALs are set based on health risks modulated by feasibility of industry to meet the standards. MALs are commodity specific, meaning that not all raw materials are deemed susceptible to all contaminants (e.g., pesticides contaminate herbs but not B vitamins). The EPA does not set a MAL for glyphosate.

Major Regulatory Programs

The current Good Manufacturer Practice (cGMP) is monitored by the FDA. cGMP requires supplement manufacturers to set meaningful specifications for identity, purity, strength, and composition of purchased raw materials and their finished products. EPA MALs guide, but do not dictate, acceptable limits of chemicals set by each manufacturer in their cGMP documents. The FDA occasionally audits manufacturers cGMP practices and even less frequently sends finished products provided by the manufacturer for 3rd party verification by an independent lab..

The United States Pharmacopoeia (USP) is a highly regarded non-profit that helps set quality standards for the supplement industry. Levels of concern overlap but are different from the MALs set by the EPA.

California’s Prop-65 sets standards with Level of Concern (LOC) for an array of chemical toxicants including some but not all toxic metals, additives or ingredients in pesticides, common household products, food, drugs, dyes, or solvents. Each chemical has a “Safe Harbor” level based on risk of causing cancer or harm to developing babies. Prop-65 LOCs are significantly more stringent than EPA MALs and USP standards. Includes Glyphosate.

Third Party Certification

Notes on 3rd party certifications

• Guided by the regulations above. Some certifications require significantly lower levels of concern. 
• Best practices include utilizing Prop-65 Safe Harbor (potentially a large array of chemicals) and Certified Organic (pesticides only). Note that many certificates use Prop-65 LOCS for 4 toxic metals only and do not test for pesticides or other chemicals.  
• Process-based verification such as Certified Organic, requires the manufacturer to meet defined standards of organic practice. Only a small percentage of finished products are tested by independent labs . 
• Consumer chain of custody verification involves random samples of finished products that are purchased from retailers  (e.g., Clean Label Project). 
• Certifications can expire due to the need for periodic audit or due to the certifying body no longer offering certification. Fact check is often needed to confirm up-to-date validation.

Examples of 3rd Party Certifications

Clean Label Project Certification based on Prop-65 Safe Harbor Levels. Certifies individual finished products, not brands. Consumer chain of custody verification.

Clean Label Pesticide Free tests for less than 5% EPA MALs for 208 pesticides including glyphosate (comparable to certified organic). Consumer chain of custody verification.

Consumer Labs Certified based on EPA MALs, USP for all compounds and Prop-65 for metals only. Consumer chain of custody verification.

Fairwild Certification (note, I have contacted this organization to see if they assess chemical contamination of the wildcrafted herbs they certify)

NSF Certified tests for 185 pesticides at EPA MALs (does not include Glyphosate). Tests for 4 toxic metals at Prop-65 levels. Process-based verification.

USDA Certified Organic sets levels for 188 pesticides at less than 5% of EPA MALs. Standards are established by the National Organic Program (NOP), while certification is granted by USDA- accredited independent agencies (e.g. MOSA, Oregon Tilth). Process-based verification.

Regenerative Organic Certified (ROC) builds upon the foundation of Certified Organic by adding requirements for soil health, animal welfare, and farmer/worker fairness. ROC represents a higher bar for agricultural practices, aiming to actively improve the land and its ecosystems. Process-based verification. 

Certificate of Analysis (COA)

COAs are documents created by the manufacturer demonstrating either third party or in-house test results for purity as well as identity and potency. Each manufacturer determines which chemicals to test for, how often to test, how many samples to take from each shipment of raw materials and each lot of finished product. They established their own LOCs that are guided by but not held to any specifics of the above regulations and third party certifications. The manufacturer must demonstrate per cGMP rules that they are testing appropriately with meaningful specifications. 

As a practitioner, you can request COAs for products from the companies you recommend or purchase supplements from. Note that COAs are often generated from in-house rather than third party testing. However, they do hold weight as they are a component of cGMP and are on file for a potential FDA audit. 

While it can be an arduous process for a busy practitioner, it is a good way to keep manufacturers accountable. It also demonstrates the level of transparency of the nutriceutical companies you depend on to provide effective and safe products for your patients. It is an excellent way to build trust with your key manufacturers and to assure that chemically sensitive and other vulnerable populations are receiving reasonably clean products. 

Stay tuned for an NAEM handout on how to request and interpret a COA.