Saturday, December 3, 2022

Supplements: The hidden dangers of unknown sources

There is a lot of scientific chaos about the use of supplements. Claims and counter–claims abound. Those who trust their supplements swear by their use. For the non–believers, there are multiple supporting papers that show little benefit.

However, the biggest risk to the supplement world is not the non–acceptance. It is the fake or adulterated supplements.

In this article, I will give you an insight into why you need to be absolutely sure about your source of supplements. First, we will see how things can go against you. Then, we will learn about real–life issues that have happened in multiple countries. In the end, I will give you some suggestions on what to do about that.

Supplements supply chain

There are three main entities involved before a supplement reaches you. And each of them can introduce problems:

  • Someone who produces the raw material can supply an inferior ingredient;
  • Someone who combines and packages the raw materials into the supplement can knowingly use an inferior ingredient, or worse, adulterate with a dangerous chemical;
  • Someone in the distribution chain might introduce a counterfeit product that looks like the original, or tampers with the genuine product.

Thus, the thing that can protect you is the regulatory oversight. And, as you will see later, the regulators are often sleeping at the wheel.

Raw material production

Supplement manufacturers source their products from existing raw material producers because it takes a different expertise to produce high quality lutein extract from marigold flowers than marketing a eye–health supplement.

To save costs, the raw material manufacturer may use lower–grade materials or processes. In turn, the supplement manufacturer might buy a lower–cost ingredient that is lower in quality, or has lesser shelf life.

For example, some giant global companies such as DuPont Nutrition and Health manufacture more than a hundred varieties of soy protein. The soy protein for use in horse feed, or pet food, will obviously be cheaper than that for human consumption. How do you know your supplement manufacturer is not buying the animal–grade soy protein instead of the human–grade one?

And even in the soy protein for human consumption, there are grades, or qualities. How do you know which one was used by your manufacturer?

When it comes to plant sources, the issues such as soil health, irrigation water supply, pesticide use, GM–seeds, processing time, and species selection can decide the cost of raw materials, as well as their efficacy.

Supplement packaging and marketing

The supplement manufacturer may use false claims, and aggressive marketing. They can use celebrity endorsements. If there are strong marketing incentives, they may get retail shops pushing the product. Some manufacturers, knowingly, add harmful chemicals to their supplement blends to get better effects. For example, adding steroids to body–building products can increase their efficacy. However, the side effects can be severe, and long–term.

Distribution chain

Often, this is the weakest link in the developing countries. Since the distribution chain there is largely unorganised, some crooks may introduce a counterfeit product that looks similar to the original. In some other situations, the original product is tampered with, or adulterated.

The real danger

The main issue with supplements is adulteration. Often, this is found in cheaper brands but that is not a necessary condition, as you will see.

Thus, the issue is not whether they work. After all, if they do not work, all you have lost is some money. If they are natural food supplements, mostly they will not cause any harm or side effects.

But, if you bought them because of some high–flying health claim, you are taking a risk. If your supplement claimed things such as improving your sexual prowess with some exotic herb that is found only in Amazon rain–forests, or jungles of Borneo or Irian Jaya, then you should be downright worried.

Let us see what problems arise due to these issues.

The U.S.A.

Let us first look at the situation in the USA. This is because most of the world looks at the USA as the benchmark, for setting their procedures.

The U.S. Food and Drug Administration (US FDA)

The Food and Drug Administration (FDA), USA is the watchdog for foods and drugs sold in the USA.

The medication industry in the USA is regulated by the FDA. Before any medication hits the store shelves, they have to be thoroughly tested in humans. The ingredients have to be listed accurately on the labels. If there are medical or marketing claims, they have to be approved by the FDA, after verifying the evidence.

As a result, if you swallow any medical tablet in the USA, you can be reasonably sure what you are swallowing.

The 1994 Dietary Supplement Health and Education Act (DSHEA)

As per the DSHEA, the above rules are only for the pharmaceutical industry. The supplements you buy in the USA are not required to follow them.

The main difference is what happens before the product reaches store shelves. While the pharmaceutical products need to follow rigorous testing before a customer can touch them, the supplements don’t need any FDA nod before they start selling.

Before the launch, it is not required to prove that the supplements are safe or effective. One can make any claims about their efficacy, as long as the ingredients are accurately labeled. Only thing that a supplement company is not allowed to do is to make a specific claim for a specific medical disease.

Here is the official statement about what FDA is supposed to do about supplements. It should be an eye–opener.

Federal regulations of dietary supplements

Dietary supplements are products intended to supplement the diet. They are not drugs and, therefore, are not intended to treat, diagnose, mitigate, prevent, or cure diseases. The FDA is the federal agency that oversees both dietary supplements and medicines.

In general, the FDA regulations for dietary supplements are different from those for prescription or over–the–counter drugs. Unlike drugs, which must be approved by the FDA before they can be marketed, dietary supplements do not require pre–market review or approval by the FDA. While the supplement company is responsible for having evidence that their products are safe and the label claims are truthful and not misleading, they do not have to provide that evidence to the FDA before the product is marketed.

Dietary supplement labels may carry certain types of health–related claims. Manufacturers are permitted to say, for example, that a dietary supplement addresses a nutrient deficiency, supports health, or is linked to a particular body function (like immunity or heart health). Such a claim must be followed by the words, “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”

Manufacturers must follow certain good manufacturing practices to ensure the identity, purity, strength, and composition of their products. If the FDA finds a product to be unsafe or otherwise unfit for human consumption, it may take enforcement action to remove the product from the marketplace or work with the manufacturer to voluntarily recall the product.

Also, once a dietary supplement is on the market, the FDA monitors information on the product’s label and package insert to make sure that information about the supplement’s content is accurate and that any claims made for the product are truthful and not misleading. The Federal Trade Commission, which polices product advertising, also requires all information about a dietary supplement product to be truthful and not misleading.

The federal government can take legal action against companies and Web sites that sell dietary supplements when the companies make false or deceptive statements about their products, if they promote them as treatments or cures for diseases, or if their products are unsafe.

Effectively, the FDA is relying on an Honour Code for the supplement manufacturers. I feel that is a bit risky, given the huge financial windfalls in breaking the code.

Also, for pharmaceuticals, it is the responsibility of the manufacturer to prove that its product is safe for use. On the other hand, for supplements, it is the responsibility of the FDA to prove that the product is unsafe for use.

Drug adulteration

In November 2015, the USA government prosecutors brought criminal and civil charges against more than 100 supplement manufacturers and marketers. They found many supplements either had no ingredient claimed or were laced with dangerous or untested chemicals.

Here are 850 supplements, and the pharmaceuticals they were laced with. While this was an article written in 2016, read further to learn that some of these products still have adulteration, years after being told to recall and change. So, this list may still be relevant.

In a paper published in Oct 2018 in the journal JAMA Network Open, the authors found that between 2007 and 2016, the FDA identified 746 brands of supplements adulterated with pharmaceutical drugs. The medications added to the supplements were prescription drugs such as sildenafil and fluoxetine, withdrawn drugs such as including sibutramine and phenolphthalein, and unapproved drugs such as dapoxetine and designer steroids.

Weight loss products

Sibutramine affects the chemicals in the brain that help in weight management. But, it was found to increase the risk of heart disease and stroke, and hence, is banned. It was added to weight loss products.

Phenolphthalein is a laxative drug, and hence, was mixed with weight loss products. It has been banned due to concerns about it causing cancer.

Fluoxetine is used for treatment of depression. But it can reduce appetite as well as the urge to eat. Hence, it was used in weight loss products.

Sexual enhancement products

Sildenafil citrate is also known by the brand name Viagra. It is used for treatment of erectile dysfunction. It was added to supplements for sexual prowess enhancements.

Dapoxetine is a product for premature ejaculation, and should not be taken by anyone who does not have that problem. It was added, too.

Body–building products

Designer steroids can help muscle growth; but have severe long–term bad effects. They were used in muscle–growth products.

As you can see, such supplements will give far better results than ordinary supplements. But you are running a significant risk of side effects. Thus, drug adulteration is a major concern, if you do not know your supplement’s manufacturer source.

Drugs that do not contain what they claim

Now, just because you deal with a manufacturer regularly, or its name is in your face daily, does not make it a safe source either. After all, Walmart, Walgreen, and Target are household names. Many of you have heard of General Nutrition Corporation (GNC), as the USA’s largest retailer of supplements.

When you buy herbal supplements from such brands, you may lower your guard down. Well, don’t yet.

New York

In Feb 2005, the New York State attorney general’s office accused these four major retailers of selling fake, and potentially dangerous, herbal supplements.

The authorities bought 78 bottles of the leading brands of herbal supplements from the stores of these companies. They analysed the products using DNA fingerprinting technology.

This technique allows one to identify plants and animals by looking up short DNA sequences which are unique to each species. The DNA sequences found in the product are matched to a large database of DNA sequences of different organisms. Thus, one can positively identify what is present in a supplement, and what is not.

80% of the products tested did not contain any of the herbs mentioned on their labels. The tablets that were labeled medicinal herbs contained cheap fillers like powdered rice, asparagus, and houseplants.

A ginseng tablet at Walgreens was promoted for ‘physical endurance and vitality’. But, it contained only powdered garlic and rice. Ginseng is an adaptogen, which helps increase mental and physical stamina. It has been used for thousands of years for stamina improvement.

A gingko biloba tablet at Walmart was promoted for ‘memory enhancement’. But, it contained only powdered radish, houseplants, and wheat. And the product label claimed it was wheat–free as well as gluten–free! Gingko biloba is a Chinese herb that increases blood circulation in the brain, enhancing memory and concentration. It has been used for thousands of years for brain improvement.

Three tablets, ginkgo biloba, St. John’s wort, and valerian root did not have any herb that was mentioned on their labels. But, they contained powdered rice, beans, peas, and wild carrots.

St. John’s wort boosts mood and so, is used for natural treatment of depression. It has been used for hundreds of years for this purpose. Valerian root is used for sleep disorders, such as inability to sleep (insomnia). It is also used for anxiety and psychological stress.

Tablets of Echinacea and Saw Palmetto at GNC did not contain the herb mentioned on their labels. Echinacea is used as a immunity booster for hundreds of years. Saw Palmetto is used for prostate health, especially to get some relief in prostate enlargement problem.

Another supplement at GNC contained some ingredients that were not mentioned on the label. Those were powdered legumes, which were used as fillers in the tablet. Some people can be allergic to legumes, such as peanuts and soybeans.

Oregon

In Oct 2015, attorney general of the state of Oregon sued GNC, saying they knowingly sold supplements spiked with unmarked, illegal ingredients.

The ingredients, picamilon and BMPEA, are not approved in the U.S., and are neither natural nor safe. They were hidden inside supplements with names, such as JetFuel Superburn and Phenyl Core Weight Management.

FDA

The Food and Drug Administration sent warning letters to five companies in Apr 2015 telling them that eight of their products listed BMPEA and to stop selling them.

The companies claimed that a plant known as Acacia rigidula was the source of the chemical. The FDA said that the plant does not contain BMPEA.

The Oregon complaint read, “despite widespread knowledge that the Acacia rigidula (AR) products sold by GNC were at high risk of having been spiked with BMPEA, including knowledge by David J. Sullivan, GNC’s Vice President & General Counsel, Regulatory Affairs, GNC continued to sell products that contained AR without testing these products to determine whether the product was adulterated with BMPEA or informing customers of a risk that these products were adulterated.”

Wow, and you are taken in by big brand names.

Still adulterated after the recall

We learned that only after the supplements are available for purchase in shops, does the FDA come into picture. It can now monitor those products, and take action, if something is found wrong. But, what about the first 10,000 people who buy the supplements, before the FDA swings into action? Tough luck!

Let us say that the FDA finds something wrong with the supplement. Either it has harmful ingredients, false claims, or incorrect labeling. What is the FDA supposed to do then?

If it finds a problem, it sends a notice to the manufacturer to voluntarily withdraw the product. Voluntarily?

If the manufacturer does not withdraw the product within a reasonable time, then the FDA sends a compulsory withdrawal notice to the manufacturer. If the manufacturer still not heed the warning, then the FDA can pursue legal recourse.

However, in all this, the consumer is never kept in the loop. Only the FDA website has information about this recall. No one else, except the manufacturer, is notified of the problem.

Now, would you believe that many products that the FDA had asked a recall for, are still available on the retail shelves? And worse, they still continue to contain the same harmful ingredients?

Here is a paper published in the journal JAMA Network Open in Oct 2018 that says that the FDA discovered 746 distinct supplements to be adulterated, but announced voluntary recalls for only 360. Thus, the majority of adulterated supplements, continued to be available for sale.

An earlier paper published in Oct 2014 in the journal JAMA Network had showed that banned drugs still continued to be in the supplements years after the FDA recall. So, who is paying attention? Not the FDA, for sure.

What about the consumers themselves? An article in Jan 2012 in the Journal of General Internal Medicine had showed that in spite of FDA recall and alerts, many consumers continued using adulterated supplements. Their sales did not decrease even after the alerts.

India

India is another country I get queries about supplements from.

ASSOCHAM, the Associated Chambers of Commerce and Industry of India, is the representative body of corporate India. In 2015, they published a report saying 60–70% of the supplements sold in India are fake, counterfeit, unregistered, or unapproved.

I personally don’t believe this number because it looks too high. However, I feel it is possible that this number is true for the three globally–suspect categories:

  • Body–building products
  • Weight loss products
  • Sexual enhancement products

The percentage of fake products in categories other than these must be lower. Even then, the point is that the biggest organisation of Indian businesses mentions so. After all, many of the spurious product manufacturers may even be members of ASSOCHAM.

A Sep 2018 article by a website, MedIndia, claims that fake body–building supplements are sold all over India. However, since there is no reference link, I would take this claim only as a view, and not trust it blindly.

Here are some suggestions by a fitness blogger, who claims to have insider knowledge of India’s body–building supplements industry, about how to ensure your body–building supplements are genuine. The main tips are:

  • Be careful when buying popular brands. That is where the fake products are more likely.
  • Check the label print quality, typefaces, spelling mistakes, trademark sign, printed manufacturing date and expiry date, distributor’s logo, protection seal, hologram, barcode, inner packaging seal, etc.
  • Check mixability and taste, if you have used a genuine version before.
  • If you get exceptional results quickly, suspect steroids.
  • Always ask for a bill, or an invoice.
  • Buy from a trusted shop. Online sources are often fake.
  • If your fitness trainer keeps pushing a product hard, be suspicious. At least, ask for a bill, if you go ahead.

My experience

In developing countries, the biggest problem is the distribution network. Since the average incomes are lower, and regulatory oversight is less, illegal activities abound in the distribution process.

Medical reimbursement

Once I asked a pharmacist friend for some high–blood pressure medicine tablet strips. He asked me if I wanted the original medicine or a cheap, fake one that looked exactly like the original. When I told him how preposterous his question was (who the hell would knowingly want a fake medicine?), he nonchalantly told me that a lot of people buy fake medicines to get medical reimbursements. They simply have to show the product strip to some office authorities, and the bill (which shows the full price) to get the money.

In a paradoxical way, the supplements may not have this blatant issue because most organisations don’t reimburse supplement costs, which are considered preventive. Only the conventional, curative medicines are paid for.

Missing ingredients

Some Ayurvedic (Indian ancient medicine) practitioners have told me that they don’t advise buying some medicines of certain well–known Ayurvedic formulations companies.

Amongst their peer–doctor circle, it is a known fact that a formulations may list 28 ingredients on the label, but in reality, will have only 10–12. Also, the ones mentioned on the label will have very little of some ingredients, especially if they are expensive.

In typical Ayurvedic medicine, there are no patents because most recipes are thousands of years old. So, any company can blend such a medicine. Also, many of them contain multiple ingredients, sometimes dozens of them, involving minuscule but essential amounts of some.

Poor neighbourhoods

Unless needed in an emergency, avoid buying supplements and medicines from shops in poor neighbourhoods. In general, people in those areas are not very educated, worldly-aware, or savvy. They may not be able to check, if the medicines are post–expiry date, or the packaging looks different from normal.

On the other hand, people in affluent areas may have presence of mind to check online about brand name alterations. They may also be well connected with authorities. The crooks may not want to mess with this possibility.

Companies and distributors wanting to push fake products mostly focus on poor or rural areas.

Company–owned pharmacies

As much as possible, try to buy from a company–owned pharmacy. A few well–known companies have their own sales kiosks. Generally, it is safer to buy from such sources, as there is a direct traceability. Also, companies may not wish to risk their reputation. So, you are likely to get a genuine product.

If there is a possibility of acquiring products directly from the parent company, bypassing the distribution chain, consider that option. This may not be possible for medications, since most countries require a pharmacy to sell medicines. However, that may be possible with supplements and neutraceuticals.

Avoid online purchases

Many online retailers offer health products at good rates. As a broad overview, I have seen that most websites selling these products call themselves a ‘marketplace’. That means, they are simply matchmakers —connecting buyers and sellers. By themselves, they cannot and do not vouch for the authenticity of the seller.

Frankly, such websites are only interested in GMV, or Gross Merchandise Value. They need to show their investors how much sale was achieved through their website. They could care less if any fake products were sold on their websites.

While most such websites claim how much they care about their customers, and what rigorous checks they follow, I have found that most of it is a hogwash.

Since the actual vendor may be located in a different part of the country, it is very difficult to check the antecedents of such sources. Even after you find something fishy, you may not be able to trace the pump–and–dump vendor.

Of course, the governments are wisening to this new mode of sales for supplements and medicines. So, new regulations keep coming. Hopefully, in a few years, the situation will be safer.

In the meantime, avoid online purchase for marginal savings. Use online purchases, only if you are getting a product which you cannot get in your neighbourhood.

Also, use online purchases, if you can get some products from the manufacturing company’s website.

I have seen some specialised products such as curcumin extract from turmeric, or certain 100% pure aloe vera juice, to be available only through the parent company’s website. This is common if a company makes good products, but fully exports them. They may have no interest in investing in a distribution network in their home country. But, if they get online sales in the country, they are happy to fulfill them. Such products may be worthwhile to buy online.

In conclusion

We see a huge amount of research published about supplements. But, how do we know that the neutraceutical used for studies actually contains the ingredient claimed, and tested for? If even the big brand companies may be selling fake products, can we really trust all the study results?

This is very important since the pharmaceuticals follow a much stricter regulatory control. So, the chances of a drug tested in a trial being fake is quite less. But that possibility exists in the supplements world. That is one more reason to be cautious in trusting results that show no benefit in a supplements trial.

Caveat emptor, or buyer beware, is the best policy when buying supplements.

Use common sense. If something looks too good to be true, it probably is. Don’t go by extreme claims.

Just because a supplement works, it does not mean it is safe. It may contain harmful ingredients.

Buy from a well–known source, who has a reputation to protect. Overall, you are safer with a renowned name.

Avoid buying from poor neighbourhoods.

Avoid buying online just to save little money. Use online sources for specialised products not available locally. Use online buying, if you can buy directly from the manufacturer.

Don’t simply rush for the cheapest supplements. They may be cheap for a reason, with less effective or missing ingredients.

Finally, there is no substitute for finding someone who is an insider in the industry, whom you can trust.
• Cultivate such a contact, and ask him for genuine sources.
• Spend time whetting that person before you trust him/her. But, once convinced, don’t try to second–guess her every advice.
• “Before trusting someone, be sceptical until proven wrong. After the trust is established, be trusting until proven wrong.”

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