Quality survey of health food tablets and capsules - they might look like pharmaceutical products, but actually not!

"Message on so-called health foods"¹ issued by the Food Safety Commission of Japan states that health food tablets and capsules are often misunderstood as pharmaceutical products from their appearance, but the quality of them may not be so rigidly controlled as that of pharmaceutical products. In some cases it appears that the amount of active substance per unit is not kept constant and that some of the tablets and capsules are not designed to be completely dissolved and absorbed in the digestive tract.

Regarding health food tablets and capsules, the Food Safety Commission of Japan issued self-check guidelines for manufacturers², which have encouraged manufacturers to make voluntary efforts to ensure safety and effectiveness of these products. In the past, some health food products lacking quality or safety were distributed in Japan,³ and it is concerned that similar problems may happen in the future.⁴

Therefore, NCAC decided to share updates and points to note on health food tablets and capsules⁵ based on results of nation-wide questionnaire survey about use of the products and outcomes from quality survey of the products on the market (100 brands) as well as those being used by consumers (105 products).

Incidentally, NCAC collected products being used by residents in Tokushima prefecture, where investigation was conducted.

¹ "Message on so-called health foods"[PDF] issued by the Food Safety Commission of Japan
^2-1 "Basic idea for proper manufacturing of health food tablets and capsules" and "Self-check guidelines for ensuring safety of ingredients for health food tablets and capsules" issued by the Ministry of Health, Labour and Welfare
^2-2 "Reports from conference for considering how to handle functional substances in the system of foods with function claims" issued by the Consumer Affairs Agency
³ "Information on safety of health foods" issued by the Ministry of Health, Labour and Welfare
⁴ "Summarized outcomes from the meeting for discussing revision of the Food Sanitation Act"[PDF] issued by the Ministry of Health, Labour and Welfare
⁵ The health foods examined by NCAC include foods with health claims and other health foods (so-called health foods).

^* The above web pages are written in Japanese.

Consumer questionnaire survey

NCAC has conducted an online questionnaire survey among those taking health food tablets or capsules in the past year. (valid responses: 10,168)

About 66 percent responded that the health food tablets or capsules they took in the past year were advertised as supplementing certain nutrients which tend to be insufficient.
About 25 percent responded that the health food tablets or capsules which they most frequently took were for supplementing nutrients, while about 20 percent responded those were for curing or alleviating symptoms.
It appeared that about 8 percent did not clearly distinguish health foods from pharmaceutical products.
More than 80 percent responded that they know the Japanese system for health foods including foods for specified health use, foods with nutrient function claims, foods with function claims, etc., while about 27 percent responded that they know the Good Manufacturing Practices (GMP).
74 percent responded that they thought health food tablets and capsules were rigidly manufactured and kept in good quality.
About 9 percent responded that they found any abnormality in quality when unpacking or using the products.

Test of products on the market

NCAC has examined the quality of some health food tablets and capsules on the market to see if there's any possibility of not being disintegrated and absorbed in the body, if the functional substances⁶ are contained as indicated, if the products are contaminated with microbes or heavy metals and so on.

Referring to the consumer questionnaire results, NCAC chose 10 common categories of functional substances ("multiple vitamins", "GABA", "black vinegar, kozu", "coenzyme Q10", "enzyme", "HMB", "lutein", "lactic acid bacteria", "glucosamine" and "DHA, EPA") and 10 brands for each of the 10 categories, searching through major online shopping sites (Amazon.co.jp, Rakuten, and Yahoo!shopping) and conducting a market survey through Google. The 100 brands tested include 21 brands of foods with nutrient function claims and 11 brands of foods with function claims.
Disintegration test results showed that 42 brands out of 100 did not disintegrate within a period of time defined for pharmaceutical products.
The amount of each functional substance of 50 brands was measured. Of these, 2 brands appeared to contain functional substances far less than the labeled amount. As for foods with function claims, there was no brand of which functional substance was less than the labeled amount. As for foods with nutrient function claims indicating any of the vitamins NCAC chose to check, the amount of vitamin was within the specified amount range, and the margin of error was tolerable.
The amount of each functional substance per unit of maximum allowable daily intake varied between brands. In particular, the amount of GABA and lutein per unit widely varied depending on brands: the largest amount was about 15 times of the least amount in case of GABA, and about 27 times in case of lutein. The results showed that the variation in the amount of functional substance per unit between brands existed also among the foods with function claims.

⁶ Functional substances examined by NCAC include substances engaged in functions in foods with function claims and nutrients in foods with nutrient function claims.

Test of health foods being used

In order to check if usage conditions affect the quality of health food tablets and capsules, NCAC collected health food tablets and capsules being used by consumers in Tokushima prefecture. At the same time, NCAC interviewed the consumers in person to inquire usage conditions of the products. NCAC chose and tested 105 items which had been kept in the original bottle and those supposed to be swallowed rather than those to be crunched.

In some cases, the content in hard capsules was hardened.
Half of the products did not disintegrate within a period of time defined for pharmaceutical products. This phenomenon was seen more often than in the case of unopened products.
In most cases, the amount of each functional substance in the products being used was slightly less than the amount contained in unopened products.

Investigation of labels and advertisements

Regarding 100 brands on the market, NCAC checked product labels on the package and advertisements on sellers' websites.

Three brands out of 100 were marked GMP or indicated on the package that the products were manufactured at GMP certified factories. On sellers' websites, 60 brands out of 98 showed GMP mark or indicated that the products were manufactured at GMP certified factories.
Ingredients, nutrients and allergens were indicated on the package of all the 100 brands.
About 30 percent of the brands were advertised on sellers' websites about ingredients and nutrients differently from those indicated on the package.
Ten brands out of 11 brands of foods with function claims indicated the way of intake and the recommended daily intake on the package. There was no indication about the way of evaluating the function or the duration of intake on the package.
There were some problematic representations and advertisements about some of the brands on sellers' websites which may give a false impression to consumers.

Advice for consumers

Consumer questionnaire results showed that about 8 percent did not appear to clearly distinguish health food tablets and capsules from pharmaceutical products, while about 20 percent responded they took the products for curing or relieving symptoms. When using the products, carefully read labels and descriptions on the package and do not intend to cure disease or to relieve symptoms. If you are using pharmaceutical products, consult your doctor or pharmacist before using health foods.
When checking the amount of functional substances, foods with function claims and foods with nutrient function claims contained functional substances within the specified amount range as indicated. On the other hand, the labeled amount of functional substance per unit of maximum allowable daily intake varied between brands. When using the products, consumers need to decide the intake based on correct information, referring to the labeled amount of functional substance.
Consumer questionnaire results showed that more than 70 percent of respondents thought health food tablets and capsules were rigidly manufactured and kept in good quality. However, disintegration test results showed that about 40 percent of the brands tested did not disintegrate within a period of time defined for pharmaceutical products. Unlike pharmaceutical products, health food tablets and capsules are not always kept in good quality. Correctly understand the difference between pharmaceutical products and health food products in the aspect of quality and system.

Request to businesses

Consumer questionnaire results showed that more than 70 percent of respondents thought health food tablets and capsules were rigidly manufactured and kept in good quality. However, it was found that some brands did not disintegrate within a period of time defined for pharmaceutical products or had a gap between the labeled amount of functional substance and the amount actually contained. NCAC requests relevant businesses to consider taking measures to improve quality of the products: for instance, formulating a standard so that the products will be manufactured with a certain level of quality satisfying the standard.
NCAC measured the amount of functional substance of 50 products on the market and found that 2 brands out of 50 had a gap between the labeled amount and the amount actually contained. NCAC requests relevant businesses to properly control production so that the gap will be minimized.
Consumer questionnaire results showed that about 57 percent of respondents did not understand well which product was suitable or necessary for them. Moreover, the labeled amount of each functional substance in the maximum allowable daily intake widely varied between brands. When you receive inquiries from consumers on how to choose or how to take, provide correct information, showing clear reasons.
Some of the sellers' websites showed representations and advertisements which may give a false impression to consumers, so please improve the expressions. Ingredients and nutrients should be correctly described on the websites.

Request to the government

Consumer questionnaire results showed that more than 70 percent of respondents thought health food tablets and capsules were rigidly manufactured and kept in good quality. However, disintegration test results showed that some of the tablets and capsules did not disintegrate within a period of time defined for pharmaceutical products. NCAC requests the government to take some measures so that a certain quality level of the products will be ensured and maintained.
Consumer questionnaire results showed that about 57 percent of respondents did not understand well which product was suitable or necessary for them. The labeled amount of functional substance in the maximum allowable amount per day varied between brands. NCAC requests the government to make further efforts to keep consumers informed about foods with function claims, referring to notified information, so that consumers can choose suitable products based on correct information.
Some of the sellers' websites included problematic representations and advertisements which may give a false impression to consumers. NCAC requests the government to investigate the matter and instruct the businesses as appropriate.

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