Only 22% of supplement brands share lab-test results (A study by bodylink)

In a post-pandemic world where health, wellness, and longevity have taken centre stage, consumers are more concerned than ever about what they put into their bodies. According to Grand View Research:

The health education space is rapidly growing too, podcasts such as The Huberman Lab by Dr. Andrew Huberman have soared to become some of the most popular podcasts in the world this year. Tongkat Ali & Magnesium L-Threonate have exploded in popularity since being discussed on The Huberman Lab in 2022.

With rapid market growth, there is an increasing need for responsibility and transparency from supplement brands to communicate that their products are clean and authentic. Multiple studies have found supplement products to have discrepancies when it came to their labelling. Contamination is also a problem as discovered by this study. So which brands can we trust to be safe?

We wanted to find out what the current level of transparency was within the top supplement brands on the market. To get this data, we needed to ask these important questions as potential customers.

We started by asking 100 of the top supplement brands in the UK and USA, if they could provide a third-party testing certificate (a certificate of analysis) for one of their listed products. This simple certificate would allow us to attain the safety of the brand's product. Let us get straight to the results.

The results

🥇 4% of brands already had public results

While investigating, we found that this group of brands had existing links to the product's certificate of analysis publicly available on their website. This should be the gold standard for complete transparency.

🎖️ 18% replied with a lab-test certificate

Just 18% of brands were able to reply to our request with a certificate of analysis. These brands should be celebrated for investing in trust and transparency with their customers. We have provided a list of these brands at the bottom of this article.

😞 29% replied with no certificate

Disappointing. These brands responded with various reasons as to why they couldn't supply a certificate. We've outlined some of the common reasons below. While they couldn't provide any factual documentation for their lab-testing, they 'assured' us that their product was free from bacterial contamination and heavy metals.

😡 49% of brands failed to reply

While it was disappointing to not receive a certificate of analysis from some brands, at least they valued their potential customer enough to reply to our query. Almost half of brands contacted in this study couldn't reply to a customer confirming safety of their product. These results are alarming and re-enforces our mission at bodylink to demand more transparency in this industry.

Study methods

For full transparency, below is the script that we used to send to each company. Some very minor details may have been changed for each brand. For instance, the supplement of interest was changed where our preferred option wasn't available.

Our preferred supplement of interest was Ashwagandha. 75% of all requests were made for Ashwagandha due to its popularity and many supplement brands offer their own branded product. With the majority of Ashwagandha being supplied from India, Africa and the Middle East, contamination of the product is a legitimate concern due to the length of the supply chain.

We first wrote to companies on 7th October 2024. We decided to allow brands two weeks to reply before publishing our findings to allow for any internal discussions and cooperation between product and sales teams to retrieve a certificate of analysis. However, any subsequent replies from brands will be updated here with the results updated.

What is a Certificate of Analysis?

A Certificate of Analysis or 'CoA' is a document issued by a third-party independent laboratory that verifies the ingredients and quality of a supplement. The document usually includes but is not limited to the following:

1. Product verification

Verification that the tested supplement is in fact what it is supposed to be.

2. Purity

Detailing the concentration of the main active compounds within the supplement.

3. Heavy Metals

CoA's commonly test the presence of harmful substances such as lead, arsenic, cadmium and mercury. Keep reading for details of specific regulations on heavy metal levels.

4. Bacteria levels

Highlighting any dangerous levels of different types of bacteria or contaminants like E.coli.

5. Harmful chemicals

Testing for residual solvents or chemicals used during manufacturing.

While CoA's are important and valuable for creating consumer trust. It is important they come from high quality and reputable laboratories. The following laboratories are well trusted and often used by companies testing dietary supplements.

• Eurofins
• NSF International

Laboratories with the ISO 17025 accreditation are seen as the gold standard for issuing an accurate certificate of analysis.

What is Informed Sport certification?

Informed Sport is another testing and certification programme that supplement brands can use to certify their products, which is more targeted towards sports use. LGC Assure, who manage the Informed Sport program test supplements with a strict anti-doping laboratory, testing for banned substances in sport. Like other laboratories LGC use ISO 17025 accredited methods.

For companies who have joined the Informed Sport programme, consumers can search the Informed Sport website for the manufacturer, brand or product to view their certification status.

What are the laws around supplement safety and testing?

Supplement regulations are stronger in the USA than the UK. The Dietary Supplement Health and Education Act (DSHEA) of 1994 is the primary law that governs dietary supplements in the USA. This law separates supplements from food and pharmaceutical drugs, stating that they do not require pre-market approval from the US Food and Drugs Administration (FDA). The Federal Trade Commission (FTC) regulations also state that companies must provide evidence to back up health claims made in advertising.

1. Good Manufacturing Practices (GMPs) regulations

Good Manufacturing Practices are a set of regulations set by the US Food and Drugs Administration (FDA) to ensure that food supplements are manufactured safely with the highest quality. Any company selling dietary supplements in the United States must abide by these regulations.

1. Quality

GMP states that supplements must be produced with he ability to guarantee identity, purity and strength. This includes product testing to ensure these standards.

2. Equipment standards

Manufacturers must maintain clean and sterile facilities and equipment must be maintained.

3. Raw Material testing

Any ingredients must be tested before use to confirm their identify. This is a potential area of weakness for the supplementation industry as the raw ingredients are often shipped from various parts of the world. CoA's from suppliers are often used here to verify ingredients.

4. Record keeping

GMP requires businesses to keep detailed records of each step of the manufacturing process.

Other regulations include

Good hygiene standards, correctly handling complaints, correct packaging and labelling and strictly no adulteration.

While GMP are an effective set of regulations, some companies voluntarily seek GMP certification from third-party organisations such as NSF International, the Natural Products Association (NPA), or USP (U.S. Pharmacopeia). The FDA does reserve the right to enforce GMPs but these third-party certifications provide extra assurance and transparency that a supplement manufacturer is working to the highest standards.

2. U.S. Pharmacopeia (USP) standards

The U.S. Pharmacopeia (USP) standards are seen as a benchmark for quality and safety in the supplementation industry. This non-profit organisation sets public standards for the identity, strength, quality, and purity of many products including dietary supplements sold in the United States. Brands can submit their supplements to the USP for testing and verification. Products that meet the USP's tests are awarded a USP verified mark.

One common area for concern that USP is testing against is the potential contamination of heavy metals. The USP upper limits for these are:

1. Lead

10 µg/day. Excessive lead is toxic for the brain and can cause kidney damage and reproductive issues.

2. Arsenic

10 µg/day. Carcinogen that can cause many cancers as well as cardiovascular and developmental issues.

3. Cadmium

5 µg/day. Excessive cadmium is toxic to the kidneys and can increase the risk of cancer.

4. Mercury

2 µg/day. Exposure can result in cognitive and motor dysfunction, as well as kidney damage.

California Proposition 65

California Proposition 65 (Prop 65) is a law passed in California during 1986 that was designed to protect drinking water and its exposure to toxic chemicals. Prop 65, requires business to provide packaging warnings on products that contain significant exposure to chemicals that cause birth defects, cancer or harm. The list of chemicals that cause such harm has over 900 substances, these include the heavy metals we mentioned above. If such product is sold in California that contains over the legal limit of a listed chemical, the packaging of that product must contain a Prop 65 warning.

Any supplement company selling supplements that can be delivered within California must abide to California Proposition 65.

Regulations for Dietary Supplements in the UK - The Food Safety Act 1990

The Food Safety Act 1990 is a general law that sets the legal framework for ensuring that all food, including dietary supplements are safe for consumption and are accurately described.

The UK doesn't have a comprehensive law like GMP in the US. Many UK supplement companies aim to adhere to the GMP guidelines without enforcement. British brands can seek GMP certification from NSF International or BRC Global Standards, which offer certification programs recognised internationally. Informed Sport as detailed above is a UK based certification program used to highlight high manufacturing standards.

Do companies have to provide a Certificate of Analysis?

No, supplement companies are not required to provide a Certificate of Analysis to customers.

In the US, under the Dietary Supplement Health and Education Act (DSHEA) companies are responsible for ensuring their products are safe and correctly labeled. They are not required by law to provide third-party testing documentation such as a CoA to customers.

It's a similar situation in the UK. Under the Food Safety Act 1990 and Food Supplements Regulations 2003, supplement manufacturers must ensure their products are safe and properly labeled but are not legally obligated to share CoA documents.

Why do we think sharing Certificate of Analysis is so important?

While regulations like GMP set the standard for how companies should conduct themselves, evidence suggests that not all companies are adhering to GMP correctly. In the UK, GMP regulations are not enforceable by law. Pair this with the low-barrier to market that companies now have with marketplaces such as Amazon and there's opportunity for bad or harmful products to hit the marketplace.

A simple way supplement brands can prove the identity, quality and safety of their product is to share their third-party Certificate of Analysis to their customers. This instantly creates consumer trust and confidence. If american brands adhere to GMP, then they should by law already have a third-party CoA to share. It's also a useful tool for british brands to highlight their own standards without the need for regulations.

It's our goal to highlight brands who do share CoA's with customers, which we believe takes the pain out of deciding which brands are safe and trustworthy.

Why couldn't companies provide a Certificate of Analysis in this study?

Surprisingly, brands that replied during our small study without a CoA stated a number of different reasons as to why they could not send a Certificate of Analysis. These include:

1. Proprietary reasons

This was the most common response. Brands that believe they have a unique formula for their product may not want to share details about the formulation in fear that it may be replicated. Another more valid reason could be that brands fear customers could misinterpret the data. However, many consumers and industry experts see this response as a red flag and would rather companies show a commitment to transparency. Brands can create redacted versions of a CoA to share with customers highlighting the important information.

2. Administrative burden

While the brand acknowledges that they do perform testing, they're openly stating that they do not care for transparency and are prioritising operational convenience, which is a poor way to build consumer confidence.

3. Transparency comes at a cost

This is a major red flag, transparency and access to safety information should not come at a cost to customers.

4. The most concerning response of all

This response from a US brand is an example of a GMP violation and further highlight the need for transparency in the market place.

Brand Heroes. Brands that replied to the study with valid Certificate of Analysis 🎖️🥇

All of these brands replied (typically within 48 hours) presenting a CoA with no additional questions or obligations required. This list also features the brands who displayed valid CoA's on their website to view.

• Applied Nutrition
• Life Extension
• Dr Mercola (Mercola Market)
• DIRTEA
• Gaia Herbs
• Global healing store
• Gorilla Mind
• Headstrong
• Himmense
• Nordic naturals
• Nutrition Geeks
• Puresport
• Shroom Shop
• Time Health
• Verve
• Vilgain
• Vitality Pro
• WowMD