It’s hard to say the quality of imports： take a look at the ＂tricky＂ health care products industry in the United States

Original: Shi Juan returns to the park

In the article "It’s time to break the myth of multivitamins", we talked about that the quality of multivitamins cannot be guaranteed, and the products may not completely contain the elements indicated in the instructions, or may contain pollutants harmful to human body. How to find reliable health care products? This paper provides some methods for your reference.

Writing | Shi Juan

With the improvement of living standards, "health preservation" has become a daily topic for Chinese people. In addition to the old ways, taking all kinds of health products has become the best choice for many Chinese people, especially the elderly. A study shows that by 2023, the nutritional supplement market in China is expected to reach 40 billion dollars, which will replace the United States as the largest nutritional supplement market in the world. There are many kinds of health care products in China market, both domestic and imported. Many people like to buy "imported" health care products, especially those from the United States, and feel that the prices are affordable and the quality is guaranteed.

However, are all American health products really good?

The rise of American health care products market

Since 1994, the American health care products market has experienced rapid development: sales in 1994 were only $4 billion, and in 2018, it has reached $42 billion. To a great extent, this increase can be attributed to a federal bill passed in 1994, entitled Dietary Supplement Health Education Act [1]. This law was initiated by some politicians who are inextricably linked with health care industry’s economy. The protection of health care products manufacturers is far more than that of ordinary consumers, which makes health care products completely unnecessary like prescription drugs, and can only be listed after strict examination and approval.

This bill relaxes the industry regulations, so that Dietary Supplement (also known as health products, including vitamins, minerals, plant extracts, etc.) can be sold in pharmacies or supermarkets without the prior approval of the US Food and Drug Administration (FDA). After the product enters the market, if consumers report adverse events after use, the FDA will intervene in supervision. The FDA will also conduct product sampling inspection from time to time. If it is determined that the supplement is adulterated, the FDA can send a public warning letter to the manufacturer or recall the products sold.

If you carefully look at the regulatory content of health care products on the FDA website, you can summarize the following important points:

1) Health products don’t need the approval of FDA.

2) American federal law does not require health care products to prove to FDA that the products are safe before going on the market.

Note: it is not proof of "effectiveness"! You don’t even have to prove safety!

3) The manufacturer does not need to prove to the FDA that the effect marked on the health care product bottle is accurate and true.

4) Generally speaking, the FDA began to formally monitor health care products after they were put on the market. Monitoring is only aimed at whether this product will cause great side effects to people and so on.

5) It is illegal for health care products to advertise that "it can cure a specific disease or delay a certain symptom". This is why health care products usually do not say that they can cure a specific disease, but only generally say that they can improve "immunity" and so on.

There are a large number of health products in the market, some of which are produced by large companies and some from very small companies. The production specifications of different companies are very different. The number of health care products is a whole order of magnitude larger than that of drugs, but the resources for supervision are limited, which means that the quality and safety of these health care products can only rely on the conscience of manufacturers and distributors before problems are found.

01 consumer’s misunderstanding

Made in America?

In Chinese, we often think that the quality of health care products abroad (such as the United States and Australia) is good. However, things are not what we imagined.

Although most health care products sold in the United States are produced in the United States, their raw materials usually come from other countries, of which more than 60% are from China, and only the last step of assembly is carried out in the United States. Manufacturers will often change the source of raw materials, and different batches of the same vitamin from the same manufacturer are likely to have different raw materials. The FDA of the United States does not require the country of origin of the ingredients on the bottles of health care products, nor does it require the country of origin. It only requires the telephone number or address of the manufacturer or distributor for consumers to contact. Because the address is not necessarily the place where the product is made, it is impossible to tell where the health care product comes from just by looking at the medicine bottle.

Photo: American-made health products. But the raw materials used may come from other countries.

The following three common health care products are basically produced in China:

① 90% of vitamin C comes from China. Scots also produce a small amount of vitamin C, but the cost of raw materials is three times that of China, so the price is much more expensive than that from China.

② At present, there is no manufacturer of biotin in other countries except China. Many so-called "Made in America" biotin is actually imported from China, and then ground and processed, and turned into American production.

③ Pure folic acid mainly comes from China. Like biotin, many folic acid claimed to be produced in the United States are imported from China and then ground in the United States. The only exception is 5- methyltetrahydrofolate (5-MTHF, a form of folic acid that is more easily absorbed and has better bioavailability), which is usually produced in the United States.

In the United States, the quality of health care products is also a big problem.

In 2015, the Attorney General’s Office of New York accused four major national retailers-GNC, Target, Walgreens (walgreen) and Walmart (Wal-Mart)-of selling fake and even potentially dangerous health products made of plant extracts [2].

The attorney general’s office tested the best-selling plant extract health care products on the shelves of these retailers, and found that four-fifths of the products did not contain any labeled plant ingredients, but only contained cheap fillers, such as rice flour, asparagus and indoor plant extracts (that is, artificially planted ordinary low-priced plants). In some cases, these substances may cause serious allergic reactions.

For example, Walgreens has a very popular self-produced brand of ginseng tablets, which claims to "improve physical endurance and vitality" and only contains garlic and rice powder. Walmart sells a ginkgo biloba extract, the real ingredients are radish, indoor plants and wheat flour, although the label claims that the product does not contain wheat and gluten. Of the six plant extract supplements tested by Target, three-Ginkgo biloba extract, St. John’s wort (St. John’s wort) and Valerian root-do not contain the ingredients on the label, but contain rice, beans and wild carrot powder. The same is true for GNC’s health care products, which use ingredients not indicated on the label as fillers, such as peanut and soybean powder, which is extremely dangerous for people with peanut allergy.

02

Natural = good?

There are still many people who think that health care products are mostly "natural" ingredients, so there will be no problem. However, even if it is extracted from natural animals and plants, the complexity of the animals and plants themselves (from the content of effective components to the pollutants that may be contained) and the industrial steps to be experienced in purification should be taken into account. Take some health care products made of plants, many different plants can be used to prepare health care products, but plants that look similar and are close in species may have very different effects. For example, many women take black cohosh extract to improve menopausal symptoms, but in the United States and Canada, consumers have suffered liver damage because the pills they take actually contain different substances with similar names.

"Natural" ingredients do not mean that they are good, and many natural substances are toxic. Toxic natural substances in food include cyanogenic glycosides in bamboo shoots, glycoalkaloids in potatoes, Furocoumarins in citrus plants (lemon, lime, grapefruit, bergamot), and many beans contain toxins called lectins. When the dose is reached, these natural toxins will cause many bad effects on people’s health, and some toxins will cause great damage as long as they are few. "Natural" ingredients are not worthy of superstition.

How to judge the quality of health products?

Because health care products don’t have to undergo rigorous clinical trials, there is actually no way to guarantee their effectiveness and safety, and there is no guarantee that they will not interact with any drugs you may take.

The only thing I can see is what is in this health care product. That is to say, does this health care product contain the ingredients it claims to have, the dosage is in line with the label, there is no pollution (such as lead and other heavy metals), and whether the ingredients can be released normally after taking the tablets.

Drugs can be tested for purity, so why don’t health products just do it?

Drugs are usually purified products, and the content of main components can even exceed 99.9%, with only a small amount of impurities. However, the ingredients of health care products may be very complex, sometimes containing dozens or even hundreds of different substances, many of which come from plants or other natural sources, which makes it difficult to detect the ingredients.

At present, the standard test method is to evaluate the components of health care products by chromatography. However, for complex products, the information obtained by chromatography is limited. Some new technologies, such as the combination of liquid chromatography and mass spectrometry, and other analysis, can obtain more accurate results. However, before these technologies are widely used, further verification is needed, and the cost must be reduced to be routine.

Drugs for treating diseases are supervised by FDA. Who wants to test the health care products that have been deregulated by the FDA? How credible are the quality inspection data published by the manufacturers themselves? The best way is to be tested by an independent, disinterested third-party organization, so that the data obtained can be convincing.

Figure: Certification marks of three major health care products quality inspection organizations

01

USP certification

You may notice that many health care products in the United States have the words "USP verified" on their bottles (pictured above). This means that the product is certified by an independent, non-profit scientist organization called "USP Dietary Supplements Verification Program". USP sets a quality standard for food ingredients and health care products, and then welcomes manufacturers to cooperate with them voluntarily and let them test their production facilities, processes and product quality. If it meets the standard, the product can bear USP verification mark. The organization also updates the certified brands and where to buy these products on the website in real time [3].

But be careful, some companies will put "USP" on the bottle label instead of the unique black and yellow "USP Verified" seal. These companies claim to meet USP production standards, but in fact their products have not been reviewed by USP. In fact, only a few health care products have "USP Verified" seal, such as some Kirkland brand health care products in Costco.

In addition, strictly speaking, USP can not be regarded as a truly independent third-party testing, which requires the voluntary cooperation of manufacturers.

Figure: USP verification mark on health care products (from the network)

02

national sanitation foundation

Another non-profit organization that independently certifies certain health products is NSF International. This organization will certify health products such as fish oil and multivitamins. In addition, it also has a "NSF Certified for Sport" project, which is particularly useful for athletes and people who use sports supplements (such as protein powder, amino acids and creatine), because it has been found that these products are sometimes intentionally doped with stimulants.

The blue and white NSF logo means that the product has been reviewed by NSF and contains the ingredients listed on its label.

Figure: NSF markers of different species [4].

03

Other test reports

There are also some independent laboratories that regularly test a series of health care products, and then publish their test reports on their websites, such as ConsumerLab.com, labdoor.com, cptclabs.com and so on. On their website, you can find many test reports and rankings of health products, but you usually have to pay to see them.

Figure: Certification mark of Consumer Lab

04

Third-party test plan of CVS in pharmacy

In 2017, CVS, a famous American pharmacy, announced that it had started testing health care products on its shelves, and had completed testing 1,400 health care products from more than 150 suppliers. Early test results show that 7% of the products are not up to standard, and the reasons include pollution, the content of active ingredients is lower than that indicated on the label, and various counterfeiting behaviors. Common fraudulent behaviors are:

1) Substitute cheap compounds for more expensive components.

For example, manufacturers sometimes add a large number of other common flavonoids, such as quercetin or rutin, to a health care product called Ginkgo biloba. These flavonoids can be found in ginkgo biloba, but the concentration is usually very low.

2) Add some prescription drug ingredients to health care products.

For example, viagra is added to some health care products that claim to enhance sexual function.

Figure: CVS’s third-party advertisement for testing the quality of health care products.

Take health care products with caution.

The certification test mentioned above is a reassurance to consumers. However, these tests often only measure a specific batch number of products, and it is still uncertain whether the next batch of products produced by the same manufacturer still meet the standards.

I want to remind everyone that many health care products have complex ingredients. Sometimes it will interact with the therapeutic drugs prescribed by doctors. For example, some health care products may change the activity of some enzymes in the liver, thus affecting the metabolic absorption of prescription drugs. The changed metabolism may increase the concentration of drugs in the blood and cause adverse reactions; Or reduce the drug concentration in the blood, making it ineffective.

A study in 2015 estimated that in the United States, about 23,000 emergency visits each year were adverse events related to dietary supplements [5]. It is best not to eat health care products casually, and should be carefully considered.

references

[1] https://ods.od.nih.gov/About/DSHEA_Wording.aspx

[2] https://well.blogs.nytimes.com/2015/02/03/new-york-attorney-general-targets-supplements-at-major-retailers/

[3] https://www.quality-supplements.org/verified-products

[4] S. R. Akabas et al., Quality Certification Programs for Dietary Supplements. J Acad Nutr Diet 116, 1370-1379 (2016).

[5] A. I. Geller et al., Emergency Department Visits for Adverse Events Related to Dietary Supplements. New England Journal of Medicine 373, 1531-1540 (2015).

The pen name is "Cats at My Will" and now lives in Boston, USA. I graduated from the Department of Biological Sciences and Technology in Tsinghua University with a bachelor’s degree, and joined a multinational well-known pharmaceutical company to engage in drug research and development after obtaining a doctorate in the United States. For more than ten years, he led the team to fight diabetes and muscular dystrophy. In recent years, he focused on the research and development of anti-aging drugs. Personal WeChat WeChat official account "Feel Free" to talk to you about medical care.

Shi Juan

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Original title: "It’s hard to say the quality of imports: the" catty "of American health care products industry | 117 threesome"

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