It’s no secret that there are a lot of bad supplement companies out there selling poor-quality and ineffective products. Get informed and learn to tell the good from the bad with this crash course in supplement manufacturing courtesy of Nootriment.
How can you tell if the supplements you are buying are quality products or not? Supplements with the same ingredient names sold online or in stores might look like identical products, but differences in ingredient sources, manufacturing processes and testing procedures can mean the difference between a health-promoting product and a potentially dangerous pill.
Consumers and regulators are picking up on this variety of product quality in today’s supplement marketplace. Consumer concern is reflected in media stories on dangerous supplements contaminated with prescription drugs, heavy metals or other unwanted compounds. Even if a bad supplement doesn’t do you any harm, it may not do you any good: not all products contain the active ingredients they are supposed to in the proper dosages.
The FDA (U.S. Food and Drug Administration) does regulate supplement manufacturers and provides production standards, but not all manufacturers follow these guidelines. It’s no secret that there are a lot of bad actors in the market selling poor-quality and ineffective products.
So what can you do to prevent yourself from getting ripped off when buying dietary supplements? There are high quality products out there, but how do you separate the good from the bad? The answer: get informed.
Being an informed consumer demands understanding how supplements are produced and regulated. Here is the information you need to be an informed buyer and find products that will contribute to your good health and not take away from it.
Controversy over Herbal Supplements
In February 2015, the Attorney General of New York sent cease-and-desist letters to four major retailers—GNC, Target, Walgreens and Walmart—ordering an immediate stop to their sale of store-brand herbal supplements like Echinacea, St. John`s Wort and Ginseng.
When these supplements were tested using a process called DNA barcoding, only 21 % of the samples contained DNA from the plant species listed on the label. [1]
For the AG, this result constituted a public health risk. And while the method used to test these supplements has been debunked, it raised a lot of questions for consumers.
The story was profiled in major news outlets across North America and the implication was hefty: not only was the efficacy of dietary supplements questionable, a bottle labeled Echinacea may not even contain Echinacea. The bad press associated with this story only worked to entrench concern among supplement users.
Fueling Consumer Concern
Researchers have identified consumer confidence as one of the main obstacles for the natural health products industry. [2] But this lack of confidence is contrasted with the number of Americans who take dietary supplements: A 2012 study conducted by the Council for Responsible Nutrition found that 68% of Americans take supplements on a daily basis. [3]
Although there are many reputable supplement suppliers and manufacturers, there is still reason for consumer concern: the FDA does not have the resources to enforce many of the regulations regarding dietary supplement manufacturing. Much of the quality control is left in the hands of manufacturers. Unscrupulous brands can take advantage of this to bring products to the market that don’t meet industry standards and consumers often have no way of telling the difference.
Added to this is understandable consumer confusion: the reality is that the science behind supplements is at times limited and always complex. The complexity of supplements is well illustrated by the questions that emerged after the AG’s cease-and-desist order: is DNA bar coding really an effective test for supplement purity? Most scientists said no.
In a recent article published in The New Yorker magazine, Markus Lipp, a senior director at the United States Pharmacopeial Convention (USP), noted that DNA can be destroyed during industrial processing, the same kind of processing involved in the production of supplements.
Some of Lipp’s colleagues at the USP (a non-profit organization that sets scientific standards for ingredients contained in food, medicine and dietary supplements) also noted that chemicals used in the extraction process can damage and degrade DNA. The researchers suggested that while DNA barcoding may be a powerful tool, it may be the wrong one for this particular job.
Think of it like this: if you were to test a cup of coffee using DNA bar coding, you might not actually find any DNA from the coffee beans. This is because DNA is a fragile molecule and is often destroyed by the heat from the brewing process. But just because there is no DNA in the cup of coffee doesn’t mean that there is any doubt about the origin of the beans (or the caffeine content of the beverage).
GNC provided a similar DNA-degradation argument in a press release issued only days after the cease-and-desist order. The company maintained that it followed all requirements of the FDA for good manufacturing and labeling practices for dietary supplements. [4] The AG eventually agreed and in March 2015 the AG’s office conceded that GNC followed established FDA protocols.
The two parties also reached an additional agreement where the company pledged to be an industry leader and work to improve manufacturing processes and practices for consumer transparency, beyond those required by the FDA. This would help the company meet New York State’s consumer protection laws, which the AG’s office suggested may not be appropriately covered by FDA regulations. [5]
But this whole episode left some consumers wondering: how are supplement’s regulated? How is the consumer protected?
The FDA and Dietary Supplements
Talking about regulation and government oversight is often enough to put most people to sleep, but understanding how dietary supplements are regulated is a key to becoming an informed consumer.
Good regulations balance the right of consumer to access a product with evidence about the safety of that product and its possible risks. National regulatory approaches for dietary supplements are usually a hybrid of food and drug regulation systems, but in most countries dietary supplements are regulated more like a food than a novel pharmaceutical.
In these cases, registration or notification systems are often used to manage the release of new products into the market.
In the US, the FDA must be notified of any new supplement that contains a New Dietary Ingredient (NDI), that is, a dietary ingredient that has not been used before 1994. This notification process does not constitute an approval of the supplement by the FDA.
Instead, the manufacturer maintains responsibility for ensuring the safety of the product before it is brought to market. The manufacturer must also establish and oversee proper production of the supplement in accordance with FDA regulations.
These requirements highlight how important industry compliance and self-regulation is in the production of supplements. While the FDA and the Federal Trade Commission (FTC) provide requirements for industry practices, following these practices is largely the responsibility of producers.
The FDA does have the right and is responsible for “taking action against any adulterated or misbranded dietary supplement product after it reaches the market”, [6] but prior to any action by the FDA it is the producers responsibility to conduct their business within the confines of federal policy.
Regulating Dietary Supplements in the United States
The Dietary Supplement Health and Education Act (DSHEA) of 1994 established the manufacturing and labelling requirements for dietary supplements in the United States. The FDA provides regulations for both the finished dietary supplements and its ingredients. More detailed regulations for the manufacturing, testing, transportation and storage of dietary supplements was released in 2007 when the FDA established current Good Manufacturing Practices (cGMPs)
The cGMPs are industry-wide standards that apply to both domestic and international companies that sell their products in the US.
These rules for good manufacturing practices apply to the entire production chain: beginning with the design, construction, maintenance and cleaning of the production facility, to product and material testing and labelling. [7]
Accurate Supplement Labels
GMPs are extremely detailed documents that are really set up to ensure that one simple but important goal is achieved: that dietary supplements contain what is listed on the label – nothing more, nothing less.
This seemingly simple requirement actually demands significant oversight by the supplement industry. It means that ingredients must be tested to make sure they do not contain adulterated products like pesticides, heavy metals or other impurities. It means that batches need to be frequently tested and the outcomes recorded to ensure that the ingredient concentrations are accurate.
It also means that the manufacturing facility has to be appropriately set up and staffed with trained people to prevent contamination (either via bacteria or inappropriate ingredients) during the production process. This all requires oversight, planning and consistent testing.
Although the FDA has the authority to inspect plants and ensure companies are adhering to cGMP standards, many companies seek independent third-party certification to verify that their production processes and products meet FDA standards. Third-party verification and adhering to cGMP standards communicates to consumers that a company takes quality production seriously.
Third-Party Registration
One of the most respected third-party certifiers is NSF International. Established in 1944 in the University of Michigan’s School of Public Health, NSF is now an independent organization accredited by a number of organizations, including the US Occupational Safety and Health Administration (OSHEA) and the Standards Council of Canada.
NSF provides a GMP Registration Program for manufacturers of dietary supplements. The Program applies to ingredient manufacturers, supplement producers, warehouse storage suppliers and any other group involved in the production and distribution chain. The Registration Program relies on the NSF’s GMP standards, which have been developed in accordance with the FDA’s cGMP requirements to meet or exceed national protocols.
Supplement manufacturers that participate in the program carry the mark of the NSF GMP Registration Program, which communicates to consumers that the company is committed to public safety.
Look for supplements with the NSF logo or another quality third-party verifier to ensure that the supplements you take are produced using best practices.
GMP Standards and Product Quality
GMP standards are important in producing safe and effective products. A lot can go wrong in a largely self-regulated marketplace and unscrupulous producers can sometimes fall through the cracks. This means navigating the supplement market can be daunting for consumers, but a better understanding of the supplement production chain can give you the information you need to make informed decisions about what you put into your body.
Natural vs. Synthetic Ingredient Sources: A quality supplement cannot be produced without quality ingredients. Whether ingredients are derived from natural sources or synthetically produced, they are often made by a bulk supplier who sells the ingredient to the supplement manufacturer.
The FDA defines natural ingredients are those derived from a natural product (like lecithin from soybeans or corn, and beet powder from beets). Alternatively, artificial ingredients are those synthesized by manufacturers.
Sometimes these so-called artificial ingredients are ones that can be found in nature, but can be more effectively synthesized in the lab (like vitamin C or ascorbic acid extracted from an orange or manufactured in a lab).
Regardless of if it’s made with natural or artificial ingredients, it is important to buy supplements made with products that have been batch tested by the producer or supplement manufacturer. This practice helps to make sure ingredients are free from any products that can be detrimental to your health (including heavy metals, pesticides or other contaminants, such as glass or regulated medications).
GMP guidelines require that supplement manufacturers verify the purity of their ingredients (see below) so look for evidence that your manufacturer is following the rules.
Herbals and other natural products can present a particular buying challenge for consumers. It’s not only necessary to ensure the supplement is safe and free from contaminants, but that the plants used to make the supplement were grown with good health in mind. The quality of soil, pest-management practices and irrigation can all impact the nutritional value of the plant.
When buying herbals it is especially important to do your research and find a producer committed to producing high-quality products using high-quality ingredients.
Ingredient Testing
GMP standards demand that supplement manufacturers verify the composition of all ingredients used to produce their product. This verification can be completed by the manufacturer or be based on a certificate of analysis (COA) from the ingredient manufacturer.
A reputable supplement manufacturer should have COAs available for all their ingredients and be able to provide the results of heavy metal and microbial screening. These verification processes should be standard procedure, so it is important to make sure your manufacturer is compliant.
A good way to do this is to make sure that the manufacturer publishes a COA on their website – a certificate of analysis – for the ingredients used in every batch and for the final product. If you cannot find it on their website, consider contacting the manufacturer directly to request a copy.
5 Tips for Buying Quality Supplements
The supplement industry is international, meaning it is more important than ever to buy from producers who exercise stringent testing practices to make sure that supplements are safe and contain exactly what is listed on the label.
The complexities of the supplement supply chain and the many vendors involved means it is extremely important to buy from supplement manufacturers that are committed to high-quality ingredients and good manufacturing practices.
Armed with an understanding of the manufacturing and regulatory processes, here are Nootriment’s top 5 tips for buying quality supplements:
- Make sure the product is made by a GMP-compliant manufacturer. Look for a GMP certification label from an independent auditor, such as NSF or USP. Or check the vendor’s website to make sure they specify the product is manufactured in a GMP-compliant facility. (Nootriment only works with manufacturers who show a commitment to product quality by following cGMPs.)
- Examine the supplement label. A proper label should include the manufacturer’s address and a complete list of ingredients. Also, look for ingredient lists that break down the content by individual ingredients instead of grouping them together in proprietary blends. Quality supplements will also list the concentration of each ingredient in the supplement.
- Seek out test results for supplements. Certificates of analysis (COA) for individual ingredients should be available on the manufacturer’s website or by directly contacting the manufacturer. Also, the manufacturer should be able to provide results of heavy metal and microbial screening.
- Research product efficacy. Every supplement is different and may be best used in a specific form. Make sure you do your research to know the ingredients, forms and concentrations that are best for each individual supplement. For example, research indicates that turmeric and curcumin supplements generally pass right through your digestive tract, but taking these supplements with piperine may improve bioavailability.
- Look for user reviews. Fellow consumers are a great source for honest supplement reviews. Once you’ve done your own background work, take a look to see how other consumers have to say about a product and its efficacy. User reviews provide a great opportunity to get a sense of how a supplement is used and how effective it is for other people.
Conclusion
One in four supplement manufacturers inspected by the FDA receives a warning letter for not properly following cGMP standards. At Nootriment, we’ve seen it all—from being taken to a “fake factory” in China to viewing shockingly inadequate manufacturing facilities right in the United States. These bad actors give a bad name to the vendors who do take the necessary steps to protect consumer health.
Many supplement manufacturers are committed to producing high-quality dietary supplements to help you achieve and maintain good health. Armed with the right information, you can find a trusted manufacturer to make sure you’re spending your money on quality, safe products.
Do your research. Ask questions. And insist on quality.
- Twilley N. How not to test a dietary supplement. The New Yorker. 10 February 2015. [Cited 11 January 2016]
- Almada AA. Nutraceuticals and functional foods: Aligning with the norm or pioneering through a storm. In: Bagchi D editor. Nutraceuticals and functional foods regulations in the United States and around the world. 2nd ed. Cambridge: Academic Press; 2014.
- Bagchi D. Preface. In: Bagchi D editor. Nutraceuticals and functional foods regulations in the United States and around the world. 2nd ed. Cambridge: Academic Press; 2014.
- Business Wire [www.businesswire.com]. GNC refutes New York State Attorney General's claims in full and robust response. 9 February 2015. [Cited 11 January 2015]
- Morrell A. GNC AG deal: Herbal supplements were in compliance, but new testing requirements instated. Forbes. 31 March 2015 [Cited 11 January 2015].
- U.S. Food and Drug Administration [http://www.fda.gov]. Dietary supplements [Updated 21 December 2015; Cited 11 January 2016].
- U.S. Food and Drug Administration [http://www.fda.gov]. Current good manufacturing practices (CGMPs) [Updated 14 July 2015; Cited 11 January 2016].
Article last updated on: May 9th, 2018 by Nootriment