Being in the industry for 25 years, you see a lot of companies that are non-compliant with FDA regulations. Here’s a little overview on how you can shop smarter and beware of the scams. For claims made on the front of the supplement label to be compliant and substantiated, a consumer should be able to turn the product around to the supplement panel on the back and see that the front label claims match up to the back supplement panel.
Naturally-Occurring Beneficial Components
There is a supplement brand out there that claims their protein will “Accelerate Recovery [with] 8300mg [of] BCAAs” (Branched Chain Amino Acids). They not only tout this on the front of their protein label, but in product videos as well. Yet, if you look at the supplement panel on the back of the product, there are no BCAAs to be seen. Where do BCAAs come from? BCAAs occur naturally in protein. In fact, ALL protein powders contain BCAAs, even the lowest-grade protein profile on the market has BCAAs.
Each batch of protein varies and the BCAA content would need to be assayed separately to even validate the naturally-occurring BCAAs. Does this company assay each batch of protein for the 8300MG of BCAAs it is claiming on its label? Undoubtedly, no. Even if no expense was spared, and each and every batch of protein was assayed, it is impossible to guarantee 8300 mg of BCAAs, because each batch of protein has varying amounts of naturally-occurring BCAAs, not a consistent amount of 8300 mg. This is a prime example of un-substantiated and non-compliant supplement labeling that is rampant in this industry. This type of labeling is false and misleading to the consumers.
Now, take notice of the little “†” superscript next to the claim on the picture. This superscript references the FDA Structure Function (SF) disclaimer. When a SF claim is followed by the 8300 mg BCAA, it reads to the consumer that they can accelerate recovery by providing 8300 mg BCAA per serving. Not only does this appear to be a guarantee, but it could even imply they are free form amino acids. By not qualifying that the BCAAs are naturally occurring from the protein and potency may vary as they have no means to guarantee the 8300 mg, this constitutes a deceptive and unsubstantiated Structure Function Claim as such a claim must be truthful and non-misleading to the consumer.
So if you are shopping for a supplement and you see a claim on the front like this one, turn the supplement around to the supplement panel. If the ingredients claimed on the front are nowhere to be seen in the panel on the back, you will know that it is an un-substantiated and non-compliant supplement label. Unfortunately, once a company has made one false claim, there are usually many more un-substantiated claims to follow in the rest of their product line.
How can BCAAs be claimed and substantiated on a protein powder? The consumer conscious way of describing existing beneficial ingredients would be to list them as “naturally-occurring”. As in our example above, the protein should note that the BCAAs are naturally-occurring (both on the front of the label and the back) and then reference a typical amino acid profile type on the back panel next to the supplement panel.
Antioxidants health benefits have been enjoying the limelight for awhile now. Many people are well-versed on the positive roles an antioxidant can provide for the health-conscious consumer. Thus, it has become quite popular to list that this supplement and that supplement contain antioxidants. How do you know what’s substantiated and what’s not?
The antioxidant nutrient content claim as defined by the FDA states that when using the words “High” to describe the amount, the supplement would have to contain 20% or more of the Daily Reference Value (DRV) or RDI per serving for that specified antioxidant. Furthermore, the names of the nutrients that are the antioxidants must appear in the claim. (Reference section 21 CFR 101.54 of FDA claim regulations)
One supplement brand makes the front label claim to have a “High Antioxidant Complex,” but there is no description or naming of these antioxidants. Upon turning the product around to the back panel, since again no antioxidants are specified, we will make the assumption that they are claiming the vitamins as antioxidants. As you read through the panel, you notice that many of the vitamins are less than 100% of their daily value. This is yet another example of a misleading and unsubstantiated claim that a consumer would be getting a “high” amount of antioxidants when in fact, the label proves otherwise.
A correct antioxidant claim can be made by saying “contains antioxidants A, C, & E” if the daily values of those vitamin components are in fact present at 100% and can be listed as “High in antioxidants” if the daily values of those vitamin components are present at 20% above their daily value potency.
Supplement brands always tend to be jockeying for position on the shelves and claiming more of this or less of that. An uninformed consumer might think this makes one product better than another. Product formulations should follow industry-based standards from leading authoritative researchers in the industry. However, certain companies strive to stand out as being different by using unsupported research to support formula irregularities.
There is a supplement brand that purports amino acid profiles that are far out of balance, like a 6.4:1:1. The balanced, standard ratio in nature is 2:1:1. The largest, most well-funded research companies that maintain expert scientists on staff continue to abide by this long-standing standard of 2:1:1.
For many years leucine, a Branched Chain Amino Acid (BCAA) has repeatedly been shown to stimulate the process of skeletal muscle protein synthesis (MPS) via the mTOR signaling pathway (Tipton 2009, Suryawan 2008, Norton 2006, Shimomura 2006, Anthony 2000). This signaling process sets the stage for the synthesis of skeletal muscle proteins (repair, rebuild, grow), and also the inhibition of muscle protein breakdown. These positive effects have caused additional research to be done that brings clarity to how supplement companies should be formulate their BCAA and protein supplements.
The majority of positive research has been done using a ratio of 2:1:1 for the BCAA’s, respectively leucine, isoleucine and valine (Shimomura 2009, 2010, Tang 2006) By looking at studies with whey, casein and total milk proteins we can see that 20-25 grams of protein or 2.0 to 2.5 grams of leucine (dairy proteins are roughly 10% leucine) will maximally stimulate the process of skeletal muscle protein synthesis (MPS) via mTOR
This is the also the upper limit for adding leucine to dairy proteins or BCAA formulas (Tipton 2009, Pasiakos 2011) The limiting factor is that once the signaling process has been set in motion, a complete protein or essential amino acid mixture must be co-ingested for any skeletal muscle protein synthesis to occur; “Our results indicate that the whey protein plus leucine in healthy young volunteers results in an anabolic response in muscle that is not greater than the previously reported response to whey protein alone” (Tipton 2009).
Moreover, BCAA formulations that over-emphasize leucine over isoleucine and valine (beyond the 2:1:1 ratio found in nature) are now showing to be problematic. Isoleucine has now been shown to ramp up glucose uptake in muscle (Morato. 2013), making a strong argument for NOT formulating BCAA supplements with unproven ratios.
So when you are comparing supplements, look at the formulations. Do they make sense? Do they have impartial, un-biased scientific evidence that supports it or are they skewing the research to generate sales? The latest and greatest supplements that claim ingredients and ratios never-before-used are usually the first to be hit with lawsuits and subsequently, FDA fines and cease-to-sell enforcement nationwide.
Look at these supplement brands as renegades more interested in bucking the standards than in consumer’s safety. They are seeking to enhance their image with faulty information that cannot be sustained. Misleading clients with false claims can never be a way to boost your image. Truth in labeling and consumer safety should always be the number one priority in building a supplement brand’s reputation.