Are Your Supplements Safe? (How to Know)

Are Your Supplements Safe-How to Know-Blog Cover-Seeking Health

If you’re reading this, you are likely among half of the U.S. population buying dietary supplements. (1) Amid the pandemic, global dietary supplement sales reached $140 billion, as demand for supporting health and wellbeing skyrocketed. (2)

It is estimated that around 85,000 dietary supplement products are currently available in the U.S. alone. (1) Unfortunately, this demand also invites increased exposure of adulterated products, contaminated ingredients, labels not meeting potency claims, and even products advertised as “drugs.” Since the beginning of the pandemic crisis, Amazon has proactively stopped more than 6.5 million natural products with inaccurate claims. (3)

When you’re shopping for supplements, it’s critical to choose a company that is transparent about its internal procedures, and that you are confident is providing you a high-quality product.

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Are Your Supplements Safe?

You can rest assured that your dietary supplements are tightly regulated at Seeking Health. We have several governing efforts supporting top-notch quality standards.

Dietary supplements are regulated by the Food and Drug Administration (FDA). More specifically, the FDA’s Center for Food Safety and Applied Nutrition (CFSAN). This resulted from the Dietary Supplement Health and Education Act of 1994 (DSHEA), which classifies dietary supplements as a special category of food. In addition to classifying dietary supplements, DSHEA also outlined the legal definition, labeling requirements, and the process for adverse event reporting for dietary supplements. (4)

Regarding safety, the FDA regulates the safety of both finished dietary supplement products and dietary ingredients. Over a decade ago, the FDA issued formal guidance known as the FDA 21 CFR 111 final rule on current Good Manufacturing Practice (cGMP). The cGMP regulations provide a system of preparation, packaging, labeling, storage of supplements and raw materials. These processes must be documented to meet specifications to ensure identity, strength, quality, and purity.

CGMP Supplements

You may find it comforting to know that dietary supplements are indeed regulated in the supplement industry and that there are laws behind these regulations. But, do these regulations alone protect you and ensure that your supplements are safe?

The answer is no.

Under the Dietary Supplement Health and Education Act of 1994 (DSHEA):

“Manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded. That means that these firms are responsible for evaluating the safety and labeling of their products before marketing to ensure that they meet all the requirements of DSHEA and FDA regulations.” (4)

From the National Institute of Health (NIH) Under the Office of Dietary Supplements: 

“Research studies in people to prove that a dietary supplement is safe are not required before the supplement is marketed, unlike for drugs. It is the responsibility of dietary supplement manufacturers/distributors to ensure that their products are safe and that their label claims are accurate and truthful. If the FDA finds a supplement to be unsafe once it is on the market, only then can it take action against the manufacturer and/or distributor, such as by issuing a warning or requiring the product to be removed from the marketplace.” (5)

The FDA puts the burden of responsibility on the manufacturers/distributors with the expectation that they follow the cGMPs. It is by law that supplement manufacturers ensure their products are safe for consumers and labeled properly.  If not, the FDA is responsible for taking action against any adulterated or misbranded dietary supplement product after it reaches the market.

Often, with the assistance of the Federal Trade Commission (FTC), they will go after the brands and take action. It’s not all that uncommon to read about armed agents showing up onsite to seize the adulterated products when regulations are not followed.

Supplement Research Not Required-NIH

Unsafe Supplements on the Shelves

Next, let’s illustrate some examples of how potentially unsafe products hit the shelves.

The 2015 announcement from the New York Office Attorney General Eric T. Schneiderman is one such example. His office sent letters to four major retailers (GNC, Target, Walmart, and Walgreens) for selling store-brand herbal nutraceuticals in New York that could not be verified to contain the ingredients listed, or had ingredients contained in the nutraceutical that weren’t listed on the label (6). Even for well-recognized brands, it is essential to do your due diligence. Your health is your responsibility to own and manage.

Is Your Supplement Brand Trustworthy?

Knowing that the FDA mandates cGMP standards for dietary supplements is reassuring.  The bigger question is to know which brands follow the mandates in areas of advertising, labeling, manufacturing processes, and procedures.

It may surprise you that in 2010, researchers found 14 of 20 dietary supplements marketed for weight loss to be adulterated with prescription weight-loss drugs. Many contained sibutramine, a weight-loss drug withdrawn from the market because it increased the risk of heart attack and stroke.

Many of the Chinese patent herbal formulas also contain undeclared pharmaceutical drugs. There was a sexual enhancement product line labeled “all-natural” that was found to contain prescription sildenafil (Viagra) and tadalafil (Cialis) (10). Ultimately, it is up to the consumer to learn how to discern and make safe choices, and it starts by looking at the advertising.

Trust Your Gut

When Grandma said, “trust your gut,” there was wisdom behind that. If you can learn how to rule out companies that aren’t following regulations, you will save yourself both time and money. Trust your instincts and common sense.

If there are any disease claims, “cures,” or verbiage that feeds excessively on fear or desperation, consider it a red flag. If it comes across as “too good to be true,” honor your skepticism. Following these practices alone will help you steer clear of companies who are not following FDA advertising requirements. You can also preview the FDA website for warning letters issued to supplement companies.

Identify the Brand

It is a red flag if you cannot find a supplement brand/company on a Google search. If you cannot acknowledge any “people” behind the brand, this can also be an early indication of a brand you cannot trust. If the company doesn’t list their direct contact information on the label, be warned!

The FDA has identified addresses on labels to later discover that the addresses correspond with post office box locations, which are prohibited.

If the lack of information on the label prevents you from contacting the brand directly, you are better off selecting a different brand from the hundreds of thousands of choices out there.

Valid contact information is imperative in the event of an adverse reaction.

Key Things to Look for in a Supplement Company

After getting a read on the marketing and advertising, look to see if there are any statements regarding cGMPs or just GMPs. These two acronyms are often used interchangeably to describe the Good Manufacturing Practice (GMP) regulations enforced by the FDA.  The ‘c’ stands for current, which requires companies to use up-to-date technologies and systems to comply with GMP regulations.

Trusted brands invest significant resources and dollars to ensure their products meet the higher cGMP quality standards. Always verify by going to the company’s website to see if their products are manufactured in a cGMP-registered facility. Registration provides reassurance that finished products are manufactured to these high-quality standards. If there’s no mention of cGMPs, you can contact the brand directly.

Some brands go as far as elaborating on detailed measures they take to ensure that ingredient identity, strength, quality, and purity for all their products are met. The most trusted brands are willing to share certificates of analysis (C of A). These scientific documents detail the identification, test results of heavy metals, microbiology, and other contaminants. These documents are all a part of required cGMP documentation. Seeking Health is happy to provide C of A for any of our products upon customer request.

GMP Registered vs. GMP Compliant

GMP Registered_Dietary Supplements

When asked the question, supplement manufacturing companies may say they are GMP compliant. Or they may even say they are GMP verified or approved. All of these are not the same as GMP registered. To be GMP registered, the manufacturer must invest money in retaining a third-party certifying GMP firm. This third party regularly audits and inspects their facility to validate they are indeed GMP compliant.

The three most common agencies are NSF International, TGA International (Australian Therapeutic Goods Association), and NPA (Natural Products Association). The FDA recognizes these agencies as “accrediting bodies.”

The NSF seems to be the most recognized of the three. NSF International is a non-profit health organization with a long-standing history of 65 years. Its mission is to improve global human health.

Manufacturers that are GMP registered demonstrate excellence and commitment in their practices across the board. This even means holding their raw material suppliers accountable by quarantining and re-testing all ingredients upon entering the building.

NSF International’s requirements under the NSF/ANSI 173 Dietary Supplements standard:

“Manufacturers must meet the GMP requirements, and products must be evaluated to confirm that they contain the ingredients and quantities shown on the label and ensure they do not contain potentially harmful levels of impurities like heavy metals or pesticides. Certification must be renewed annually to ensure each product continues to comply with all requirements to maintain product certification. Manufacturers are audited to verify they are following best-practice procedures for production and process control systems, personnel, the physical plant and grounds, equipment and utensils, holding and distribution.” (7)

FDA Supplements

Who Manufactures Supplements?

One of the most common methods within supplement manufacturing is for brands to outsource their manufacturing services to contract manufacturing or outsourced manufacturing.  Contract manufacturing companies are manufacturing specialists. Nowadays, with all the cGMP mandates, manufacturing is costly to ensure adherence to proper sourcing, infrastructure, quality control, regulatory compliance, laboratory testing, and technology regulations. Manufacturing large-scale run sizes applying the latest technology in manufacturing helps to guarantee brands can get the highest quality products. State-of-the-art manufacturing facilities can cost tens of millions of dollars on up.

In today’s regulatory environment, brands work very closely with their contract manufacturer, as if they are an extension of their own company, which requires extensive communication. There’s a high correlation between transparency and trust every step of the way as they exchange quality documents, validate test results, and conduct in-person visits so the brands may audit the facilities. A trusted manufacturer encourages the audits and is proud to show off their commitment to quality and innovation to ensure they produce the highest quality products. If they are unwelcoming, this would be a reason for concern.

Manufacturing Specialists are Experts

Manufacturing specialists offer guidance for product development. They advise brands on how to achieve the best stability profiles. For example, the majority of probiotic strains on the market have proven to be far more stable in a vegetarian capsule than in a gelatin capsule. Probiotics made with bottling in polyethylene terephthalate (PET) bottles should never be used. This material and structure allow for more moisture than high-density polyethylene (HDPE). While costly, the CSP® brand vials, with a desiccant in the bottle wall, have proven to be highly effective at maintaining the low water activity of the probiotic contents throughout shelf life, even at high-humidity storage conditions. (8)

Supplement manufacturing specialists know how to formulate in ways that ensure the product meets the expiration dates. You may not realize that most formulas have extra amounts of each ingredient to meet the label claim at the time of expiration.

As much as brands get excited about new product launches and may want to combine many ingredients into one formula, a high-quality manufacturing specialist will decline the business if they know the formulation can’t be made to high-quality standards. For example, combining most of the common strains of probiotics with botanicals that contain high water activity poses a problem to probiotics.

Brands and their manufacturing specialists have a symbiotic relationship such that both need one another to thrive in their businesses. Therefore, brands that put quality first will pay top dollar to select manufacturers they can rely on and trust. After all, the end product will be a reflection of the brand.

cGMP Supplement Manufacturing Requirements

The FDA has close to 100 pages of audit items for dietary supplement manufacturers to ensure they comply with the cGMP mandates. Along with 3rd party certifying cGMP agencies, the FDA also conducts audits. It is not uncommon to take an entire week to complete their audit.

To provide an overview of manufacturing cGMP requirements:

  • Suppliers must be qualified by the manufacturer to determine compliance with cGMP requirements related to the quality, testing, and documentation of raw materials.
  • Manufacturers are to quarantine all ingredients entering the building until test results are completed.
  • Ingredients are re-tested and do not rely on the raw material supplier’s test results alone.
  • Ingredients are tested for identity to ensure there is no adulteration.
  • Ingredients go through potency analysis.
  • Ingredients are tested for heavy metals such as lead, cadmium, mercury, and arsenic.
  • Ingredients are tested for microbiological analysis, such as mold, yeast, salmonella, and E. coli.
  • Allergens are separated from non-allergens and handled by trained personnel only.
  • Rigorous sampling and inspections are documented throughout the entire manufacturing process.
  • Quality documentation and retained samples must be maintained for a specified number of years.

There’s a big emphasis on testing and confirmation testing every step of the way in the cGMPs. If any of these steps are missed, there can be serious consequences. Sadly, there was a recent Salmonella outbreak in 2021 traced back to an herbal supplement in Denmark. There were 33 hospitalized, and three died. The product has been recalled and is currently under investigation. (9)

Throughout the entire manufacturing process, there are multiple cross-checks and sign-offs by Quality Managers. The processes and procedures are equally as important as the ingredients. It’s no wonder you can find up to 100 pages of audit items throughout the entire manufacturing process. If you have any questions regarding manufacturing, always ask your brand!

Heavy Metals in Supplements

The Bottom Line

When evaluating supplement brands, it is necessary to validate honesty, transparency, and integrity for your own safety.

Cheaper brands do not always hang around for the long haul. Products are continually being recalled. The FDA continues to issue warning letters. With recent all-time high sales of $140 billion in the global dietary supplement market, unsafe products are somewhere on the shelves or online.

There’s a right way to manufacture, and there is a cheap way. Be picky in selecting brands. Trust your inner guidance. Do your due diligence by getting to know your supplement brands more. Verify that their manufacturing practices are 3rd party cGMP registered. Most importantly, know that you can always achieve better health, no matter where you are on your health journey. Nutritional supplements are often an important part of that journey.

Here at Seeking Health, we are committed to providing you with high-quality, bioavailable supplements that you can trust. We do not sacrifice quality for profit. We strive to go above and beyond the average supplement company. We do this by allocating significant resources to testing all of our supplements for purity, potency, and label claims. Click here to learn 10 ways we test your Seeking Health supplements.

Our founder, Dr. Ben Lynch, is genuinely committed to sourcing the highest quality ingredients we can find. He founded Seeking Health over a decade ago because the supplements he saw on the market were lacking potency, purity, and effectiveness. He created Seeking Health to fill this need. Ultimately, Dr. Lynch wants you to be empowered in your own health, which starts with understanding how to find and choose the best supplements for you.

Learn more about our core values here.

Seeking Health is proudly cGMP registered with NSF. Click here to see our GMP certificate.

Seeking Health is cGMP Registered


References

  1. https://doi.org/10.1080/10408398.2018.1524364
  2.  https://www.grandviewresearch.com/industry-analysis/dietary-supplements-market
  3.  https://www.ice.gov/news/releases/hsi-partners-pfizer-3m-citi-alibaba-amazon-merck-protect-consumers-against-covid-19
  4. https://www.fda.gov/food/dietary-supplements
  5. https://ods.od.nih.gov/HealthInformation/ODS_Frequently_Asked_Questions.aspx#Information
  6. https://ag.ny.gov/press-release/2015/ag-schneiderman-asks-major-retailers-halt-sales-certain-herbal-supplements-dna
  7. https://www.nsf.org/knowledge-library/supplement-vitamin-certification
  8. https://doi.org/10.3390/microorganisms7030083
  9. http://outbreaknewstoday.com/denmarks-salmonella-outbreak-linked-to-herbal-products-19422/
  10. Low Dog, Tieraona, M.D. (2016). Fortify Your Life. National Geographic Partners.

Dietary Supplement Resources

PubMed®

A service of the National Library of Medicine, PubMed® contains publication information and (in most cases) summaries of articles from scientific and medical journals. For guidance from NCCIH on using PubMed, see How To Find Information About Complementary Health Approaches on PubMed.

Website: https://pubmed.ncbi.nlm.nih.gov/

Office of Dietary Supplements (ODS), National Institutes of Health (NIH)

ODS seeks to strengthen knowledge and understanding of dietary supplements by evaluating scientific information, supporting research, sharing research results, and educating the public. Its resources include publications (such as Dietary Supplements: What You Need To Know) and fact sheets on a variety of specific supplement ingredients and products (such as vitamin D and multivitamin/mineral supplements).

Website: https://ods.od.nih.gov/

Email: ods@nih.gov

U.S. Food and Drug Administration (FDA)

The FDA oversees the safety of many products, such as foods, medicines, dietary supplements, medical devices, and cosmetics. See its webpage on Dietary Supplements.

Toll-free in the U.S.: 1-888-463-6332

Website: https://www.fda.gov/

Center for Food Safety and Applied Nutrition (CFSAN)

Part of the FDA, CFSAN oversees the safety and labeling of supplements, foods, and cosmetics. It provides information on dietary supplements. Online resources for consumers include Tips for Dietary Supplement Users: Making Informed Decisions and Evaluating Information.

Toll-free in the U.S.: 1-888-723-3366

Website: https://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CFSAN/

Federal Trade Commission (FTC)

The FTC is the Federal agency charged with protecting the public against unfair and deceptive business practices. A key area of its work is the regulation of advertising (except for prescription drugs and medical devices).

Toll-free in the U.S.: 1-877-382-4357

Website: https://www.ftc.gov/


These statements have not been evaluated by the Food and Drug Administration (FDA). This product is not intended to diagnose, treat, cure, or prevent any disease.

This information is for educational purposes only. No product results are implied.

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