Author: HealthyWay Staff Writer

Most Americans have some experience with dietary supplements.
Head into any grocery store or pharmacy and you’ll see them: Dozens of lime-green bottles, carefully arranged under a big sign that says something like “nutrition” or “natural health.”
Each bottle is packed with tablets, capsules, and pills, with labels extolling the virtues of things like fish oil and probiotics. Look closely, and you’ll see asterisks beside these benefits, and on the back of the bottle, a disclaimer from the U.S. Food and Drug Administration (FDA).
Whether you give your kids Flintstone vitamins (the most delicious cartoon-based vitamin, in our humble opinion) or you’re hopping on the collagen powder trend to try to improve your skin health, you’re likely using some type of dietary supplement in your everyday life.
About 76 percent of Americans take dietary supplements, according to the Council for Responsible Nutrition (CRN), a supplement industry advocacy group. The majority of Americans express confidence in the safety, effectiveness, and quality of those products.
Still, unless you’ve made a concerted effort to learn about the supplement industry, you might not know exactly how those supplements work—or whether they even contain the active ingredients you’ve paid for. As we learned, dietary supplements vary greatly in terms of benefit, risk, and even product quality. If you’re considering any type of supplement, here’s everything you need to know to make an informed decision.

How does the FDA regulate dietary supplements—and why aren’t they more strictly regulated?

Let’s start by addressing the most common criticism of dietary supplements: They’re poorly regulated.
Pick up any bottle of vitamins and you’ll see the word “supplement” somewhere on the label. You might also see this message: “This product is not intended to diagnose, treat, cure, or prevent any disease.” You’ll almost always see this one: “These statements have not been evaluated by the Food and Drug Administration.” Why doesn’t the FDA take a bigger role?
That’s a somewhat complicated question, because the FDA does regulate the industry to some degree. Dietary supplements have been popular for decades, but the industry has changed substantially since Congress passed the Dietary Supplement Health and Education Act of 1994.
According to the law, supplements aren’t medications, they’re a class of food. And they’re not subject to the rigorous FDA oversight afforded to medications. Supplement manufacturers have to clearly label their products, but they don’t have to explicitly prove that they’re safe before bringing the products to market.

“A dietary supplement is defined as a food,” says Joseph Feuerstein, MD, who is a board-certified physician practicing at Stamford Hospital and assistant clinical professor of medicine at Columbia University College of Physicians and Surgeons. “But while [a supplement] may come as a capsule in the same way as a medication comes in a capsule, you can’t assume that it has the same quality of manufacturing and safety as a medication.”

That’s not to say that the market is completely unregulated. The FDA explains their approach on their website:  
“In general, FDA’s role with a dietary supplement product begins after [emphasis added] the product enters the marketplace,” the site reads. “That is usually the agency’s first opportunity to take action against a product that presents a significant or unreasonable risk of illness or injury, or that is otherwise adulterated or misbranded.”

In other words, if a supplement seems dangerous, the FDA will step in.

Dietary supplement manufacturers are legally required to report “serious adverse events” that occur after a product hits the market. They’re also required to keep records of those events and present them to the FDA as needed.
“Dietary supplements are absolutely regulated,” says Steve Mister, president and CEO of the CRN. “The FDA has oversight over our labels, they control what ingredients are considered legal, and they oversee the manufacturing of the products. …Food products don’t have the adverse event reporting requirement, but supplements do. Our regulations are quite a bit more stringent than [regulations] are for food.”
The FDA can recall supplements if they make misleading claims or if they present a serious danger to consumers. Supplement manufacturers must also register their facilities with the FDA, and they’re subjected to fairly strict labeling requirements.
Still, our sources agreed that supplements aren’t held to the same rigorous standards as pharmaceuticals. What’s to stop a supplement manufacturer from selling sugar pills as multivitamins?
Dietary supplement manufacturers are required to follow the Current Good Manufacturing Practice (CGMP) rule, which ensures that supplement manufacturers follow the same practices established for food manufacturers. Violators face fines and recalls. Additionally, many manufacturers are part of industry trade groups that enforce their own standards (as we will discuss later).
Mister says that the FDA has plenty of power, but he believes that the administration doesn’t always have the resources to exercise that power.

“We’re always talking to the FDA about doing more enforcement,” Mister says. “We do know, quite candidly, that there are products in the marketplace that should not be there. They’re patently illegal, because they’re putting [in] ingredients that shouldn’t be there, or they’re making claims that they shouldn’t be making. The thing is, they’re already illegal—what we need is a more active FDA with the resources to enforce existing laws.”  

When used properly, dietary supplements can be beneficial.

We love the idea of taking a tiny capsule that will instantly resolve all of our dietary deficiencies. As you might have guessed, though, that’s not exactly how supplements work. Used incorrectly, they’re potentially dangerous, but used under supervision, they can be an inexpensive means of improving health.
“Full disclosure, I use dietary supplements all the time,” says Feuerstein, referring to his medical practice. “It’s just that I do it in a clinical setting where I know what I’m giving, where it comes from, and what the purpose of it is—and it’s under a physician’s supervision.”
The FDA also specifically notes that certain supplements can be beneficial. Folic acid supplements, for instance, can reduce the likelihood of some birth defects, so obstetricians often recommend them to pregnant women.

We mentioned that to Feuerstein, who quickly noted that an overabundance of folic acid may increase the risk of certain cancers (although researchers are still studying the extent of the link). While a person is less likely to experience harmful side effects when taking water-soluble supplements—for instance, folic acid or vitamin C—Feuerstein recommends a cautious approach.

“All fat-soluble vitamins, in high enough doses, can cause toxicity,” he says. “You don’t get a prize for getting too much of a nutrient. You usually get a problem.”
Mister notes that according to the CRN’s research, most consumers tell their physicians about their supplement use.
“For consumers, their most trusted source of information [regarding supplements] is their doctors,” he says. “We encourage people to talk to medical professionals—nurse practitioners, doctors, naturopaths, and pharmacists—when making decisions.”

Herbal dietary supplements can present other issues.

There’s also a big difference between nutrient supplements (such as vitamin capsules) and botanical supplements.
“A botanical—an herbal supplement—has a myriad of physiologically active ingredients,” Feuerstein says, “and you can get [supplements] in a dose that would have a significant effect on the human body.”

Some toxicologists believe that the growing herbal supplement industry should be subjected to additional regulations or, at the very least, additional scientific study. Botanical supplements can have unexpected side effects, since they’re pharmacologically complex.
“If you’re using that type of supplement, you should be seeing someone who’s trained in herbal medicine, because it can interact in medications or other supplements and can be toxic,” Feuerstein says.
“It’s important to talk to [health professionals] about the supplements you take,” Mister says, “particularly if you’re also using prescription medications.”  

Is there a way to choose safer supplements?

If you’re thinking about taking a supplement, you might want to check to see whether you can get the same effect by modifying your diet. For example, if you are looking into taking a folic acid supplement, consider eating more cereals, leafy green vegetables, or pastas. If you believe you have a nutrient deficiency, you should speak with your physician.
“That doesn’t mean Dr. Google,” Feuerstein says. “Google isn’t your doctor. It’s basically a glorified medical textbook … it can’t provide the advice you need.”
He notes that dietary deficiencies can’t be self-diagnosed, since the human body is complicated. Vitamin D levels, for instance, typically rise in the summer months, since people are exposed to more sunlight. As such, a person who needs a vitamin D supplement in the winter might need to stop supplementing during the summer.

Some organizations analyze dietary supplements before they get to market.

Let’s assume that you’ve done your homework—or, rather, your clinical work. You’ve spoken with a medical professional, you’ve had relevant tests, and you’re fairly certain that you need a specific supplement. What’s your next step?
“Since 2002, some of the top United States [supplement] manufacturers have voluntarily undergone testing and supervision via the United States Pharmacopeia [USP], which supervises them independently of the government,” Feuerstein explains. “They voluntarily undergo testing by the USP, which also oversees medications … These supplements would be de facto pharmaceutical-grade substances.”
USP-verified supplements have a green symbol that indicates they’ve been tested for heavy metals and impurities. USP verification isn’t available for all types of supplements, however.
“USP is one type of independent certification,” Mister says. “NSF is another one, and UL is another. Those are probably the three best-known organizations for supplement testing.”
We should note that those organizations have different standards for evaluating supplements, so it’s important to research them carefully before relying on the labels. Feuerstein also recommends looking at other countries’ supplement laws.
“In Europe, herbal supplements are made by pharmaceutical companies that have herbal divisions,” he says. “For example, Madaus, which is a German pharmaceutical company, also makes herbal remedies. In Germany, these are prescription strength, and they are prescribed by physicians.”
“So I use the German pharmaceutical-grade product that I know is high quality, I know it’s at the correct dose, and I use it according to the specifications of Commission E [a German scientific advisory board]. I’m literally using this instead of a medicine.”

That doesn’t mean that you should rush out and load up on those supplements, of course.

“I do not advise that people do this via Google,” Feuerstein warns. “I advise they go see someone who knows how to supplement safely and is medically trained.”

With all that said, are dietary supplements worth the trouble?

Well, yes. They can be helpful, even if they’re not officially “intended to diagnose, treat, cure, or prevent any disease.” They’re also fairly inexpensive, for the most part, especially when compared with medications.

We asked Feuerstein whether he’d endorse new regulations on the dietary supplement industry. He says that that decision is best left to other people—in particular, patients.
“I do like the availability of supplements,” he says. “I’m not sure that introducing more layers of regulation, so that they’re regulated like medications, would be a good thing. But my primary concern is the health of patients, so I think it’s important to emphasize that people should make these decisions with the help of appropriately trained medical professionals.”
Mister agrees with that assessment.
“The 1994 law carefully balanced consumer safety with consumer access,” he says, “and we think the law struck the right balance. We wouldn’t want to see pre-market approval for these products. That would resemble the way that pharmaceuticals are regulated, and it would absolutely cut down access. It would increase prices and limit consumer choice.”

We can’t stress this enough: If you’re considering taking any dietary supplement regularly, speak with a physician.

We realize that we’re repeating that point, but that’s because it’s absolutely critical. To take supplements safely, you need to speak with a medical professional who can assess possible interactions, monitor side effects, and recommend a safe dosage.
“It is important to talk to one of those people about the supplements you take, particularly if you’re also using prescription medicines,” Mister says. “Research brands individually, and then, of course, talk to your healthcare practitioner. Talk to them about the supplements that you use and ask if they have recommendations.”

Sean McCaffrey, doctor of chiropractic, is an internal health specialist with post-doctoral licenses in internal and digestive health. It’s the second specialty that guides his approach to a supplement like collagen powder. After all, if you can’t digest a substance, what’s the point?
“With collagen, when you bring it in, can the body absorb it? That’s the question. And once it gets absorbed, can it be utilized and transported to where it needs to be used by the body?”
The research he’s reviewed doesn’t contain anything that’s convinced McCaffrey to recommend collagen supplements over, say, bone broth and a healthy diet.
“Everything that I’ve seen to this point, and that I’ve seen in clinic, says … hit and miss,” McCaffrey says. “More miss than hit.”     
But there is a growing body of research that points, however vaguely, toward very particular health benefits associated with collagen products. According to the PubMed timeline, interest in the health benefits of pharmaceutical collagen began in the early 1990s, when researchers began to study the effects of collagen-laced bandages for wounds (they do help).
Collagen powder, on the other hand, is a form of the protein designed to be ingested, and it doesn’t appear to have entered the medical literature until the mid-1990s. One early study found that 10 grams of collagen hydrolysate per day improved the effect of the bone-strengthening drug calcitonin in women with postmenopausal osteoporosis.
That’s terrific if large-scale follow-up studies confirm the findings—and you have postmenopausal osteoporosis and a prescription for calcitonin—but it’s a far cry from the age-defying skin improvements featured in many manufacturers’ claims. Before you buy a $50 jar of a supplement, it’s important to figure out if collagen powder is worth the expense.
But before we go any further, we need to define some terms. Let’s dig into the language that producers use for their collagen-based supplements.

What exactly is collagen? What about collagen peptides, hydrolyzed collagen, and collagen powder?

Collagen is the most common protein in the human body. It’s present in skin, bones, teeth, muscles—you name it. Collagen is made of three chains of polypeptides, or strings of conjoined amino acids, which form triple-helix patterns. Animal cells produce these triple-helices, then secrete them into the extracellular regions of the body, where they bind together into collagen fibers. These fibers are tough and flexible. In other words, they give the structures of our bodies their strength and elasticity.
You can see why it makes a kind of instinctual sense that consuming collagen could improve the skin and joints, which are partially made of the substance, after all.
But what exactly goes into our collagen supplements? These products are typically marketed under three different names: collagen peptides, hydrolyzed collagen, and collagen powder.

• Collagen peptides are short chains of amino acids that have been “unstrung” from their triple-helix structure. Their low molecular weight makes them easy for the body to absorb according to manufacturers of collagen peptide products. 
• Hydrolyzed collagen is just another name for collagen peptides. It refers to hydrolysis, the chemical process by which collagen helices are broken down into their constituent peptides.
• Collagen powder is the dry, fine particulate of collagen peptides, often mixed with other ingredients such as vitamin C, flavorings, or fillers. Scientists have identified at least 16 different types of collagen, although the first three are the ones typically associated with the skin, joints, and bones. That’s why most collagen powder formulas contain some blend of collagen types I, II, and/or III.

While those in the industry might use the above terms to differentiate their products from others, they essentially describe the same thing.
“You’ll see this a lot, in the supplement industry especially,” says McCaffrey. “They’ll use a catchy phrase, catchy terms, to try and make what they’re selling you look a little bit better.” The bottom line? “It’s really the exact same thing.”
Look closely at the small print on a package of collagen powder before you buy. It’s especially important considering the different sources of collagen—which brings us to our next point. Vegans and vegetarians, pay close attention.  

What are collagen powder supplements made of?

Your approach to collagen supplements is probably going to be similar to your stance on Jell-O, gelatin, and other seemingly meat-free foods that are actually made of animal by-products. In fact, gelatin itself is largely comprised of collagen that isn’t fully processed into its component peptides.
In 2016, the International Food Research Journal published a comprehensive piece on the process of extracting collagen from animal sources. According to that research, most collagen supplements start out as the otherwise-unused bits of pigs and cows, although products derived from fish and poultry are also available.
But which unused bits are we talking about? Well, researchers point to a handful of specifics from cattle, including the membrane that surrounds the heart, inner skin layers, and bones. Manufacturers may start with pig skin and lungs. Fish-sourced collagen might come from skin, scales, cartilage, fins, and/or swim bladders. Many—but not all—producers of collagen powder list the source animal on the product label.

How do producers manufacture collagen powder supplements?

Once producers obtain their raw materials, they extract the collagen peptides through hydrolysis, or the breaking down of chemical bonds using water. This process typically starts with pretreatment in an acid or base chemical bath, along with plenty of washing in distilled water.
Depending on the source material, manufacturers then use an enzyme or chemical solution to further break down chemical bonds and separate out the collagen peptides. At that point, all that’s left is to throw the filtered liquid collagen solution into a centrifuge to remove the moisture. In the end, you’re left with pure collagen powder.
So, to reiterate: Vegetarians and vegans might want to steer clear of collagen supplements, just as they would products that contain gelatin. Plant cells don’t make collagen. (Okay, there is one exception, but it relies on some next-level genetic engineering and isn’t available as a powdered supplement as of this writing.)

Does research back any claims of health benefits from collagen powder supplements?

Let’s break down the two major proposed benefits of collagen powder, one at a time:
[sul title=”The Skin Claim” subheader=”Collagen powder can improve elasticity, hydration, and reduction of wrinkles.”]
It makes sense, right? Collagen is the stuff your cells produce to support your skin in the first place. Aging naturally reduces your body’s production of collagen—we lose about 1 percent of our collagen production per year after age 20—which is what leads to the thin, dry, wrinkled skin that we associate with aging.
Indeed, there are some preliminary studies that seem to back up the oceans of online anecdotal support for collagen powder’s efficacy as an anti-aging supplement. One double-blind, placebo-controlled study did find improved skin elasticity in women who took a daily dose of collagen peptides. But there were only 69 subjects, and the study only lasted 12 weeks. This is a great start, but it’s a long way from establishing medical consensus.
A later study in the journal Nutrients found that collagen peptides sourced from cow bone tightened up lax, aged skin—in mice. That study was from November 2017, and as any medical researcher will tell you, it takes time to move from mice to humans when studying potential drugs. This, again, places us squarely in preliminary-study land.
In short, it is certainly possible that collagen powder can improve skin health. There just hasn’t been enough research on hydrolyzed collagen peptides to convince the healthcare industry at large.
“I have not seen enough research to validate it,” says McCaffrey. “I’ve just not seen enough behind it to validate what it does.”    
[sul title=”The Joint Claim” subheader=”Collagen powder can improve joint health and ease osteoarthritis.”]
Again, the logic of this claim comes from the idea that the articular cartilage found in joints is largely composed of collagen. Why wouldn’t eating collagen give your body more collagen to use in your joints?
The answer lies in your digestive tract, says McCaffrey. When we digest proteins—including collagen, whether in a slab of fish or something in supplement form—a healthy digestive system breaks them down into amino acids, which become basic building blocks for other proteins. There doesn’t appear to be a way to encourage these fundamental amino acids to form precisely the tissue that we want in precisely the preferred part of the body.
“The body will reassemble [amino acids],” McCaffrey explains. “Think of them like Legos. If I give you a bag full of Legos, and I say, ‘Hey, build me a car,’ you and 90 other little kids are all going to build different cars. It depends on where you put the red [Legos] and the blue ones, and so on. So the body can kind of selectively choose how it wants to reassemble these things into different forms of collagen.”
Even if you can digest a collagen supplement, there doesn’t appear to be a mechanism that controls the body’s use of amino acids to rebuild tissues in specific parts of the body.
That said, preliminary studies—emphasis on the preliminary—suggest that collagen supplements may help ease activity-related joint pain in athletes, and general joint pain for people 50 and older.    
To quote the conclusion of that latter study, though, “More studies are needed to confirm the clinical interest of this food supplement.”

Are there any risks associated with consuming collagen powder?

Remember that as dietary supplements, collagen powders aren’t subject to FDA oversight. It’s up to manufacturers to ensure that their products are safe before they bring them to market.
But MedlinePlus, the U.S. National Library of Medicine’s public-facing information site, lists the risks of consuming gelatin and related compounds, such as collagen powders, as “likely safe” in smaller doses and “possibly safe” in the doses recommended by many supplement manufacturers.
Barring the possibility of allergies, which are always a concern, McCaffrey doesn’t worry too much about the safety of collagen products.
“The supplement industry as a whole is pretty cautious,” McCaffrey says. “I think they tend to put things out—especially over-the-counter-type supplements…that [are] not going to hurt you. They don’t want to get sued. So when you’re putting a product out there, you make sure it’s not strong enough to hurt anything.”
The potential problem with animal-based supplements is that, well, they come from animals. Not every fish whose fins are destined for a beauty product swims the same clean waters.
“The real issue becomes where they’re getting their sources from,” McCaffrey says.
“When you’re getting your collagen, you get a lot of it from animals, and it’s gelatinous things. It’s leftover parts for the most part. [Manufacturers] aren’t sitting there with a $2,500 organic cow going after this stuff. They’re buying whatever they can get their hands on.”
There’s no way to know what an animal has been exposed to in its life, and it could be possible for contaminants to remain even in heavily processed byproducts like collagen powder.
“How was that animal fed in its life?” says McCaffrey. “Did it have hormones? Did it have this, did it have that? You can get into cross-contamination and things like that.”

Potential Side Effects of Collagen Powder Supplements

The main thing to avoid when taking collagen supplements is an allergic reaction. How do you know if you have such an allergy? Look to the source animal. If you’re allergic to chickens or eggs, avoid collagen supplements derived from poultry. If you have fish or seafood allergies, avoid collagen powders sourced from the sea.
MedlinePlus and WebMD list other potential side effects, ranging from the mild (leaving a bad taste in your mouth) to annoying (heartburn, belching), to frankly terrifying (potential contamination with animal-borne diseases—though this one is particularly unlikely, for the record).   

So should you take collagen powder as a dietary supplement?

That’s up to you and your doctor. In general, though, McCaffrey says he suggests getting your proteins, including collagen, from whole-food sources.
“You see a lot of your collagen in the skins of things,” he says. “You’ll see it in chicken skins…You can find it in the gelatinous portions, but people don’t tend to eat the joints and knuckles and things like that. That’s where making the broth can be really helpful.”
Broth? That’s right. McCaffrey is a big fan of bone broth, which he says makes it easy to get plenty of collagen into any meat-eater’s diet. He also recommends preserving the collagen that’s already in your body and working against the natural loss of collagen that inevitably accompanies aging.
“Are there things that we can do that slow the rapid decrease [in collagen production?] McCaffrey asks. “There are. I call it the three Ss. It’s sugar, sunshine, and smoking.”
Avoid these three things—the first two in excess and the third entirely—and you’ll get about as close to the fountain of youth as you can in this world.
“More than anything,” McCaffrey says, “don’t always look for the quick fix.”