Hello everyone and thanks for coming to check out our Synutra Pure Blog! In this piece we will be revisiting the important difference between food grade supplements vs. pharmaceutical grade. This distinction is very important, as it can help provide certainty in quality while choosing the right supplements to add to your diet. In this updated blog, we will also be discussing the middle ground between food grade and pharmaceutical grade, the USP (United States Pharmacopeia) standard for supplements.
Starting with food grade, let’s discuss what these terms mean. For something to be food grade, it has to either be a material/ingredient that is safe for human consumption or a material that can safely come into contact with food products.1 This means that food grade can be applied to both a product and the materials or equipment used to make that product. All in all, the takeaway is that for something to be food grade it has to be safe for humans to consume. A fair assessment, but being food grade just means a product is very unlikely to harm you if you consume it. It doesn’t mean it works, or that the product is pure enough or high enough quality to work the way the supplement is intended.
As you shop for supplements, you may notice a massive price difference among supplements in different stores. For instance, there are some supplements you can find in a dollar store, for a dollar. The initial thought is often; “Great! I can get what I need for a dollar!” And while yes, you can get a bottle of something for a dollar, the question you should ask is “Should I?” When looking after your health, you should do what you can to educate yourself as a consumer. One of the facts of the matter is, quality tends to increase a product’s price range. This doesn’t mean that the most expensive product is the best, but it does mean you should consider making purchases using second or even third thoughts. If you spot something for a dollar, and the next cheapest alternative is twenty dollars at another store, consider that food grade rules only set standards for safety, not quality. So while a dollar store item is likely safe and made to food grade standards, think about why it is only a dollar.
If you want to talk about something that has a higher quality to it, it's time to talk about pharmaceutical grade standards. For something to be pharma grade there are certain standards for it to meet. First off, that means finding, identifying, and quantitating every impurity.2 From there, there are these things called monographs, a detailed study written about a very specific subject or aspect thereof. These monographs define what it is to be a verifiable version of a substance or compound. It sets the standard that has to be met by all ingredients of that type that claim to be pharma grade. So the pharmaceutical monograph defines what it means for an individual item to be pharma grade, then all products that want to meet that standard have to reach the same values of quality set forth by the pharmaceutical monograph indexed by the FDA. To meet this standard, all sorts of Good Manufacturing Practices (GMP) have to be designed and followed, including anything covered in the monograph for production of an ingredient so that the producer can reach that monograph standard, which is very difficult. This results in a much higher quality product than a food grade alternative, and in turn can mean the difference between a product that has an effect or not.
Our resident expert Jana Hildreth, our Director of Technology and Scientific affairs has the following to say on the subject: “So basically if you are looking for an efficacious material, say for your joints, one has purity, potency, and efficacy requirements in regards to dosage that fulfill the whole monograph while the other, food grade, is just assumed safe for consumption with no standards or monographs set.”
The third aspect of standards is USP verification. The USP, or United States Pharmacopeia, is an independent non-profit scientific organization that works to provide standards in the supplement industry and the pharmaceutical industry. The USP is known for setting federally recognized standards. For drugs, meeting USP standards is a given. A drug cannot be sold if it doesn’t meet pharmaceutical standards that are often set by the USP and federally reviewed. No drug will say USP Verified in the way a supplement does, because all drugs meet that standard in order to be legal.
On the supplement end of things, food grade is the minimum federal requirement. USP verification for supplements sits firmly above food grade standards as a sort of middle ground between food grade supplements and pharmaceutical grade supplements. A USP verification covers four things during their auditing process.
First, they verify that the product contains all of the ingredients declared on the label and that it meets the potency and quantity stated on the product label.3 It has been found over the years through testing that many supplements do not meet their own label claims. The contents of some products either don’t match the label, or contain varied amounts of key ingredients (some times more, some times less) that are listed on the label. A USP label essentially says, “We’ve looked at this one and the contents match the label claims.”
The second step is verifying that there are no harmful contaminant levels within the product.3 At certain quantities, contaminants can pose a health risk. Contaminants may include heavy metals such as lead, as seen in some turmeric adulteration cases, or pesticides that may pose a health risk. The USP verification process checks that these things aren’t present in harmful quantities. A lot of the time when quantifying content levels of some trace elements we’re talking in parts per million, or PPM. Some substances are regulated in PPB, or parts per billion, as well. In a monograph there will be “acceptable” levels for contaminants and rules for the PPM or PPB you can’t exceed for a specific item. As an example, the acceptable PPB for lead in bottled water is 5 PPB.4 What this means is that 5 parts out of a billion parts looked at in testing are allowable as lead. An overwhelmingly miniscule percentage.
Step three is to make sure that the supplement in question can break down and spread throughout the body in a specified amount of time.3 If a supplement doesn’t break down and absorb into the body properly then you are not getting the full benefit of the product. The process makes sure that the ingredients break down correctly and are absorbed properly, meeting performance standards.
The fourth and final step in the process is making sure that the product has been produced to the standard of the FDA’s current Good Manufacturing Practices.3 cGMPs, as we’ve discussed earlier, are a vital piece of verification that a product is made in sanitary conditions with well maintained procedures. Part of this includes making sure the entire process is well planned, well documented, and well recorded. cGMPs help maintain consistency in products by providing a step by step methodology for producing a product so that it comes out the same every time. This helps regulate quality from batch to batch.
So, there are three degrees of standards in the dietary supplement industry. To be a dietary supplement, a product has to meet food grade standards for safety. The middle ground, USP verification, is optional and not required by the Federal Government to be a supplement. The standards are higher, but it is typically something companies opt in to. Worth noting is that nowhere in the USP process are purity requirements set, other than meeting those a company has set for themselves with label claims. They test to make sure you are what you say, not that you meet a purity standard they have set. Pharmaceutical Grade, what is often considered to be the highest tier, maintains even higher standards and to get there uses most of the procedures USP uses in verification. cGMPs are written up and met, standard operating procedures are designed, monographs are referenced, and so on.
As an example of grading, our newest batch of Green Formula Chondroitin Sulfate is classed as pharmaceutical grade. You may ask, “If Chondroitin Sulfate is a dietary supplement in the US, how can it have a pharmaceutical grade?” And this is a great question. The European Union recognizes Chondroitin Sulfate as a drug, and not a supplement. While the US does not share that recognition, we produce our chondroitin sulfate to the high production requirements of the EU Pharma Standard anyway. When we first got into the business we recognized that we had the option to produce a food grade supplement, but such a decision did not meet our personal standards. So we determined it was necessary to walk the path less traveled, and aim for high purity and high quality. The EU Pharma Standard is a much harder mark to hit, but that’s our target anyway! If you have any questions regarding our purity claims, we have a “Traceable Quality” tab on our website where you can enter your product Lot Number and receive access to CoA, or certificate of analysis, that provides data verifying our label claims.
In this blog we cover a topic near and dear to our hearts, standardization and verification in dietary supplements. For some, this may be your first experience with a Synutra Pure Blog and we wanted to thank you for reading! To those coming back, thank you! We hope our expansion of this topic to talk about USP verifications in addition to the Food Vs Pharma Grade conundrums has answered some of the questions we’ve been seeing recently. We hope you’ve found our expanded discussion on this topic beneficial!
As always, this information is not intended to diagnose or treat any illness or disease. No information in any of our blogs should ever be used as a substitute for medical advice from your doctor or another qualified medical professional.
References
1) Matt Krysiak
“What Does Food Grade Mean and Why is it Important?” June 23, 2020
https://www.mpofcinci.com/blog/what-does-food-grade-mean-and-why-is-it-important/
2) Vitality Aesthetic & Regenerative Medicine
https://varmedicine.com/how-do-you-know-if-a-vitamin-is-pharmaceutical-grade
3) “USP Verified Mark”
https://www.usp.org/verification-services/verified-mark
4) “Lead in Food, Foodwares, and Dietary Supplements” June 29, 2022
U.S Food and Drug Administration
https://www.fda.gov/food/metals-and-your-food/lead-food-foodwares-and-dietary-supplements
5) 'Conscious Consumer: The Reality of Pharmaceutical-Grade Supplements'
https://www.thefacilitydenver.com/post/pharmaceutical-grade-supplements
