Heavy Metals‘ is a term used to describe certain elements which are known toxins to the human body. Lead, mercury, cadmium, arsenic, and chromium are the elements that are most-often discussed in the context of supplements and nutritional products. Heavy metal testing is a cornerstone of any GMP-certified manufacturer’s quality assurance program, and an absolute must to ensure consumer safety.

Toxic Heavy Metals

Heavy metals testing helps to identify the amount of certain toxic elements within consumer products, especially supplements. The most-commonly tested for compounds are those which are found in the highest amounts naturally in living matter like plants. These are of the highest concern because they are most-likely to be in organic compounds such as foods and dietary supplements. The term ‘heavy metals’ is a bit non-descriptive of the actual cause for concern — which is focused only on a handful of elements. The FDA doesn’t explicitly state which compounds qualify as toxic metals, though it is generally regarded as being lead, mercury, cadmium, arsenic, and chromium. These are inorganic metals that have been known to cause toxic effects in their naturally occurring forms.

Sources of Heavy Metals

Heavy metals are naturally occurring compounds found in the Earth’s crust. These compounds are generally regarded as being unable to be created or destroyed; only able to be redistributed throughout the soil. For this reason, every farm on Earth has a unique profile of heavy metals found in its soil. In most cases the levels of these compounds aren’t of concern. Most cases of contamination stem from man-made issues such as pollution and commercial waste disposal. Many plants absorb these heavy metals as they grow as part of their natural growth cycles. This causes no issues in most cases, though science has shown that sometimes different species are capable of absorbing higher levels 1. There are many other potential avenues by which supplements can be exposed to these types of materials. Water supplies and non-Food Grade manufacturing equipment can also pose potential exposure risks. Heavy metal contamination is still a risk even in the face of robust quality assurance measures. Shifts in topsoil composition, wearing of equipment, and undetected contamination all pose very real threats. The best approach for manufacturers to ensure consumer safety is to establish effective pre-production and post-formulation testing practices.

FDA Regulation

The FDA has a complex set of guidelines to ensure supplements sold in US markets aren’t a danger to consumers. This set of rules is referred to as the Current Good Manufacturing Practices (cGMP), and is often seen as a certified seal on dietary supplements. Violating cGMP guidelines results in action from the FDA, but supplement makers aren’t required to submit products to regulatory testing before sale. Instead, cGMP outlines manufacturers should develop and have in place a robust series of quality assurance practices and monitoring systems to ensure “identity, purity, strength, and composition” 2 The FDA conducts random inspections of manufacturers to ensure adherence to cGMP, but there is no formal certification program manged by the FDA. Third party agencies such as NSF International offer registration programs where manufacturers can gain cGMP certification. This is a popular means of boosting consumer credibility, and supplements labeled as being NSF-GMP registered are of a much higher-quality than non NSF-GMP supplements. Typically, these products will bear an NSF certification on the label, but if you are unsure you should check with your supplement brand before purchasing.3

Per-Ingredient Regulation

In one response to how manufacturers should consider toxic substances and how they relate to natural compounds, the FDA responded as such: “We do not have a “zero tolerance” policy for such unavoidable contaminants but we have issued some regulations and guidance to address certain common contaminants4 There’s a lot of discussion surrounding this topic, and the essence is that GMP asserts that manufacturers establish and maintain a method of testing for these contaminants. The types of ingredients to be tested are subject to manufacturer knowledge, and their testing methods are established by the manufacturer as well. This is (kind of) an honor system inasmuch as the effectiveness is established by the manufacturer, and it’s adherence to that established quality program is what’s enforced by the FDA. With specific regard to heavy metals, the FDA has relied on manufacturers to establish their own upper limits on an ingredient-specific basis. In our opinion, this is pretty Willy Nilly and it’s best to defer to trusted third party organizations such as the American Herbal Products Association (AHPA) for more holistic guidance.

Upper Limits for Heavy Metals

The AHPA is a consumer advocacy organization that is heavily focused on natural plant-based ingredients found in consumer products. As a demonstration of their commitment to consumer safety, they devote a considerable amount of effort into aggregating industry standards, regulatory guidelines, and current scientific data to establish best-practices for heavy metals found in consumer goods. The latest guidelines, updated July 2012 5, lists the following recommendations for heavy metals and consumer goods:

  • Inorganic Arsenic: 10mcg/day
  • Cadmium: 4.1mcg/day
  • Lead: 6mcg/day
  • Methyl-Mercury: 2.0mcg/day

It’s important to note that these are recommendations for products based on their daily recommended dosages. For example, a product containing 1.0mcg of trace methyl-mercury per serving should advise to not exceed 2 servings per day. Unfortunately, this still places a lot of burden on consumers to consider the net total of heavy metals they are exposed to on a daily basis. For example; if one product you take contains 8mcg of inorganc arsenic per daily recommended dose — you could take it and still be within APHA guidelines. If you were taking a second product that contained 4mcg of inorganic mercury as well — that’d but your daily total to 12mcg of inorganic arsenic.

California & Scary Labels

Some States such as California have established their own guidelines for disclosing potentially dangerous products to consumers. Legislation such as the 1986 Safe Drinking Water and Toxic Enforcement Act (Proposition 65) require manufactures attach warning labels to products containing any traces of harmful compounds such as mercury and lead.6 These labels are often very scary, and contain statements like “This product contains a compound known to the State of Californian to cause Cancer and birth defects.” The truth is that most of these toxic heavy metal compounds are found naturally in the Earth’s crust. Plants used in herbal supplements naturally absorb trace amounts of these compounds when they grow. For example; you’d likely get the same trace amounts of heavy metals from a whole food vitamin C supplement that you would from eating the foods listed on the label. The only difference is that in California bananas aren’t labeled as carcinogenic — but the supplement would be. Buying form supplement brands that contract with quality manufacturers can help ensure you aren’t being exposed to dangerous levels of these compounds.

GMP Manufacturing

GMP manufacturing guidelines are a powerful framework to help consumers ensure adequate safety from their supplements. The ambiguous nature by which the FDA regulates many such facets of product quality still allows this to leaves much interpretation up to manufacturers. For this reason, it’s important for supplement brands to assert the practices established and maintained by themselves or manufacturers to safeguard against these types of issues. When purchasing supplements, always look for labeling to indicate NSF-GMP compliance. The vast majority of supplement brands don’t actually manufacturer their own products, but contract out that process to larger more qualified facilities. This is ideal in many cases as it allows larger manufacturers to dedicate more resources to maintaining GMP practices effectively, while brands can focus on R&D and product development. This separation between seller and manufacturer can cause some disconnect in monitoring GMP practice however, and you should always seek to understand where a brand manufacturers their supplements. There are several steps that consumers can take to help ensure supplements are produced in quality GMP conditions.

1. Ask Brands Where Their Supplements Are Made

Most supplement brands don’t make their own products. They conceive the formulation in many cases, but the vast majority of supplement brands utilize contract manufacturers. In most cases this is actually a good thing for consumers, as it ensures new brands are able to have access to cGMP certified manufacturing facilities. Before buying supplements from a new brand, you should always ask them who manufacturers their products. Many times, you will get a response similar to ‘we manufacture all our own … “ when they really don’t. There’s no advantage in misrepresenting oneself here; if your brand won’t tell you exactly where their product comes from you shouldn’t buy from them. Open and transparent manufacturing is the best way to ensure quality throughout the supply chain. Modern logistics have allowed brands to offer better products to larger markets, especially in the context of supplements and food. Anyone with a bit of extra cash can start a supplement company, but only those willing to invest in quality manufacturing and quality assurance should be considered. If a brand isn’t open about where their products are made, it’s likely because they’re skimping on quality control and ingredient quality in order to make larger profits.

2. Check Manufacturer NSF-GMP Facility Registration

When manufacturers describe where and how their products are made, it’s important you audit their responses. NSF International maintains a full listing of supplement manufacturers that have been registered through their cGMP certification program. This includes cGMP and cGMP For Sport as well, and can take some time to peruse in it’s entirety. Some brands have invested a considerable amount of money into maintaining their own manufacturing facilities. These are typically the practitioner chain brands, but some other supplement brands have made such investments as well. If you don’t see you brand on that list don’t worry — it’s more than likely the use a contract manufacturer. If your brand tells you their manufacturers name, and you don’t see them on they list — then you should reconsider the products you buy.

3. Check FDA Warning Letter database for Manufacturer and Retailer

Another valuable tool for consumers to use in assuring supplements are safe is the FDA warning letters database. The FDA makes public all findings of cGMP violations — spanning from mislabeling to inadequate qualification of raw material providers. These letters offer insight into manufacturers that have had infractions in the past, as well as the steps taken to regain compliance. Additionally, NSF International maintains an active listing of complaints, notices, and enforcement actions of manufacturers that are found to violate the terms of their NSF-GMP certifications. By consulting these two resources, you can stay up-to-date on violations of supplement manufacturers. It’s important to note; there are reports of companies that receive violation notices simply closing their doors and opening as another business to clear this record.

Final Considerations

Heavy metals are a bit of a misnomer, though the term has come to be accepted as a description for potentially toxic compounds such as lead, methyl-mercury, cadmium, inorganic arsenic, and chromium. These compounds are natural components of the Earth’s crust, and are absorbed by plants during their natural growth cycles. Herbal supplements are therefore susceptible naturally for these types of trace elements to be found, though usually they are present in safe amounts. Manufacturing processes often expose products to these types of compounds. To ensure consumer safety, it’s vital that manufacturers adhere to rigid quality heavy metals testing programs as an integral part of their overall quality assurance program. The FDA’s cGMP guidelines help to establish best practice within the industry. Organizations like NSF International help protect consumers by offering cGMP certification programs. This certification ensures products are meet identity, purity, strength, and composition standards set forth by the FDA. By being mindful of total heavy metal contents of all your supplements, and checking that your brands are NSF-GMP certified — you can rest assured you are doing as much as possible to avoid heavy metal toxins in your products.

Notes:

The article Heavy Metals Testing Ensures Better Supplement Safety was originally published on the Isotrope website.

References:

https://bmcplantbiol.biomedcentral.com/articles/10.1186/1471-2229-13-103

https://www.fda.gov/Food/GuidanceRegulation/CGMP/ucm110858.htm

http://www.nsf.org/consumer-resources/look-for-the-nsf-mark

https://www.federalregister.gov/d/07-3039/p-1503

http://www.ahpa.org/AboutUs/AHPASPolicies/GuidancePolicies.aspx

https://oehha.ca.gov/proposition-65/general-info/proposition-65-plain-language