台灣有一個網頁叫做”台灣氫水實驗室”，看起來是一些氫氣的專家寫的。有些文章很值得參考。因為很喜歡這個網頁，這網頁的連絡信箱是hworker77086600，我曾經寫信去問過這個名稱的由來，原來77086600是氫氣研究者的一個密碼(內部連絡之用)。所以我就在設這個私人博客時也用了這個密碼，表示我對氫氣研究工作的認同與支持。
說來有趣。最近看到一個網頁["氫水"台灣氫水研究中心]，看起來似乎也是要推廣氫氣的知識，起初頗喜。更多研究者願意花時間推廣氫氣知識當然是美事一樁。網頁上放了一些有關氫分子醫學的論文。這些文獻其實也都是一些公開的文獻。也有若干網站協助整理PO出來讓大家參考。這並不為奇。但仔細研讀["氫水"台灣氫水研究中心]，卻愈看愈困惑。
["氫水"台灣氫水研究中心]看起來像是專門要挑戰”台灣氫水實驗室”而製作的網頁。
當然。科學的探討各有其本。無可厚非。
但既然要講科學，就真的必需以科學角度檢驗。推廣正確的科學知識。是善知識。若以科學為名，確包裝著偽科學的說法，用心就可議。
恕我直言
[台灣氫水實驗室] 我看到最早的資料是2010年4月。現在是2015年9月。
有五年半的時間持續在耕耘這個網頁。宣導正確的氫氣知識。
流覽人次。29萬多人次。
["氫水"台灣氫水研究中心] 2015年5月6月間幾天內就把一些文章PO上去。
看不出流覽人次。但。怎麼看都像是山寨版。說真的。如果他真的是要推廣氫氣醫學的知識。沒有必要做成這樣讓人有點真假難辨。
這就是山寨。
他寫了似是而非的文字:
當然。科學的探討各有其本。無可厚非。
但既然要講科學，就真的必需以科學角度檢驗。推廣正確的科學知識。是善知識。若以科學為名，確包裝著偽科學的說法，用心就可議。
恕我直言
[台灣氫水實驗室] 我看到最早的資料是2010年4月。現在是2015年9月。
有五年半的時間持續在耕耘這個網頁。宣導正確的氫氣知識。
流覽人次。29萬多人次。
["氫水"台灣氫水研究中心] 2015年5月6月間幾天內就把一些文章PO上去。
看不出流覽人次。但。怎麼看都像是山寨版。說真的。如果他真的是要推廣氫氣醫學的知識。沒有必要做成這樣讓人有點真假難辨。
這就是山寨。
他寫了似是而非的文字:
例: ["氫水"台灣氫水研究中心]提出。
[只要含有氫氣的水，就叫做氫水]。所以- -電解水，添加鎂製作的水素水。都是氫水。
氫水的最高飽和溶解度是 1.6ppm=1600ppb。
[只要含有氫氣的水，就叫做氫水]。所以- -電解水，添加鎂製作的水素水。都是氫水。
氫水的最高飽和溶解度是 1.6ppm=1600ppb。
這個見解讓我非常困惑。
所有只要含有橙汁口味的水，都叫做純澄汁? 即使只有一點點味道，也可以稱為純汁?所以—添加橙香料與宣稱為橙口味的水都稱為純橙汁。政府規定
100%澄汁稱為純橙汁，添加20%純橙汁稱為稀釋橙汁，添加2%純橙汁稱為橙風味飲料。這包300cc橙汁中含有1.6ppm=百萬分之1.6=1600ppb=十億分之1600=純橙汁?
["氫水"台灣氫水研究中心]究竟是要將科學講清楚?還是只是要為不含氫氣的電解水或是含有十億分之1600的[加鎂水素水]護航?
然而。在飲水中添加鎂。化學式: Mg+H2O=MgO+H2(鎂+水=氧化鎂+氫氣)，雖然產生了十億分之1600的氫氣。但是留在水中的氧化鎂是需要說明的，而飲用者是否會產生飲用過量氧化鎂而產生的鎂中毒，也是不能迴避的。
["氫水"台灣氫水研究中心]網頁。除了讓我困惑之外。一定必須一提的是其對於美國食品藥物管理局(FDA)
GRAS Notice No. GRN 000520.公告。移花接木於自己的論述。這會造成許多人的誤解。這樣真的不好。FDA GRAS Notice No. GRN 000520.公告原文如下:
看得懂英文的朋友應該相當多。一般朋友也可以借由翻譯軟體來閱讀這個公告
但竄改FDA公告，將公告中氫水的規格改成自己認為的濃度要求。這確實讓我驚訝，台灣的法令難到對於這樣的事情沒有罰責嗎?
["氫水"台灣氫水研究中心]說法如下:
(根據美國食品衛生管理局FDA所發布的GRAS報告中揭示，氫水是安全的食品添加物，
對於生物體無毒性，且不可燃，具有強的抗氧化特性，用在保鮮、天然的抗氧化，可添加在純水、飲料、汽水之中，
氫水的飽和溶解度為0.0127ml H2/ ml H2O 換算後等於1.6ppm =1600ppb
即是最高飽和濃度，而FDA建議的每日攝取量以3.2毫克為上限)
對於生物體無毒性，且不可燃，具有強的抗氧化特性，用在保鮮、天然的抗氧化，可添加在純水、飲料、汽水之中，
氫水的飽和溶解度為0.0127ml H2/ ml H2O 換算後等於1.6ppm =1600ppb
即是最高飽和濃度，而FDA建議的每日攝取量以3.2毫克為上限)
["氫水"台灣氫水研究中心]說:
氫水的飽和溶解度為0.0127ml H2/ ml H2O 換算後等於1.6ppm =1600ppb
FDAFDA所發布的GRAS報告中揭示
氫水的飽和溶解度為0.0214ml H2/ ml H2O 換算後等於2.14%
不知是美國FDA說了算還是 ["氫水"台灣氫水研究中心] 說了算?
不知是美國FDA說了算還是 ["氫水"台灣氫水研究中心] 說了算?
FDA公告原文中對照如下:
Agency Response Letter
GRAS Notice No. 520Return to
inventory listing: GRAS Notice InventorySee also Generally Recognized as Safe (GRAS) and about the GRAS Notice Inventory
CFSAN/Office of Food Additive Safety
CFSAN/Office of Food Additive Safety
November 28,
2014
Cody Cook, M.D., Ph.D.
MitoGene Beverage Company, LLC
401 S. Cedar Street
Little Rock, AK 72205
Re: GRAS Notice No. GRN 000520
Dear Dr. Cook:
The Food and Drug Administration (FDA) is responding to the notice, dated April 28, 2014, that you submitted in accordance with the agency’s proposed regulation, proposed 21 CFR 170.36 (62 FR 18938; April 17, 1997; Substances Generally Recognized as Safe (GRAS); the GRAS proposal). FDA received this notice on May 14, 2014, filed it on June 2, 2014, and designated it as GRAS Notice No. GRN 000520.The subject of the notice is hydrogen gas. The notice informs FDA of the view of MitoGene Beverage Company, LLC (MitoGene) that hydrogen gas is GRAS, through scientific procedures, for use in flavored beverages, drinking water, and soda drinks, for the purpose of preventing oxidation in the beverage products, at levels up to 2.14% by volume.
該通知的對象是氫氣。該通知告知MitoGene飲料公司，有限責任公司（MitoGene）的觀點FDA氫氣是GRAS，通過科學的程序，用於調味飲料，飲用水和蘇打水飲料，防止氧化的飲料產品的目的，溶解率高達2.14％（體積）。
Cody Cook, M.D., Ph.D.
MitoGene Beverage Company, LLC
401 S. Cedar Street
Little Rock, AK 72205
Re: GRAS Notice No. GRN 000520
Dear Dr. Cook:
The Food and Drug Administration (FDA) is responding to the notice, dated April 28, 2014, that you submitted in accordance with the agency’s proposed regulation, proposed 21 CFR 170.36 (62 FR 18938; April 17, 1997; Substances Generally Recognized as Safe (GRAS); the GRAS proposal). FDA received this notice on May 14, 2014, filed it on June 2, 2014, and designated it as GRAS Notice No. GRN 000520.The subject of the notice is hydrogen gas. The notice informs FDA of the view of MitoGene Beverage Company, LLC (MitoGene) that hydrogen gas is GRAS, through scientific procedures, for use in flavored beverages, drinking water, and soda drinks, for the purpose of preventing oxidation in the beverage products, at levels up to 2.14% by volume.
該通知的對象是氫氣。該通知告知MitoGene飲料公司，有限責任公司（MitoGene）的觀點FDA氫氣是GRAS，通過科學的程序，用於調味飲料，飲用水和蘇打水飲料，防止氧化的飲料產品的目的，溶解率高達2.14％（體積）。
再提出這句說明 at levels up
to 2.14% by volume. 氫氣溶解率高達2.14％（體積）。
MitoGene
describes the identity of hydrogen gas (CAS registry number: 1333-74-0).
Hydrogen gas is also referred to as molecular hydrogen gas. Hydrogen gas has a
molecular weight of 2.016 grams (g)/mole; its specific volume is 11.986 meter
(m)3/kilogram
(kg); and its solubility in water is 0.0214 milliliter (mL) hydrogen (H2) (gas)
/mL water (H2O) (liquid (liq)). MitoGene describes hydrogen gas as a non-toxic,
flammable, lighter-than-air gas that reacts with oxidizing compounds. When
hydrogen gas is dissolved in water it is chemically stable and not flammable.
MitoGene描述氫氣（CAS登記號：1333-74-0）的身份。氫氣也被稱為氫氣分子。莫耳數為2.016克（克）/莫耳(分子量); 1公斤的氫氣體積為11.986立方米; 氫氣在水中的溶解度為0.0214cc（mL）氫氣（H 2）（氣體）/ mL的水（H2O）（液體（LIQ））。MitoGene描述氫氣作為一種無毒，不燃，輕於空氣的氣體與氧化性化合物發生反應。當氫氣被溶解在水中它是化學穩定的和不可燃的。
and its solubility in water is 0.0214 milliliter (mL) hydrogen (H2) (gas) /mL water (H2O) (liquid (liq)) 這一段要特別再提出來翻譯一次
氫氣在水中的溶解度是: 0.0214cc(mL)(氫氣)(氣體) / 1 cc(mL)(水)(液體)
再說明:
氫氣在水中的溶解度為 1cc的水中可溶解0.0214cc的氫氣。100cc水中可溶解2.14cc氫氣。
氫氣是氣體，水是液體。並不容易相互溶解。溶解率較低。但是100cc的水中仍可溶解2.14cc的氫氣。因為是氣體與液體相互溶解。氣體與液體都用cc(體積)來計算與表示，才是正確的。
and its solubility in water is 0.0214 milliliter (mL) hydrogen (H2) (gas) /mL water (H2O) (liquid (liq)) 這一段要特別再提出來翻譯一次
氫氣在水中的溶解度是: 0.0214cc(mL)(氫氣)(氣體) / 1 cc(mL)(水)(液體)
再說明:
氫氣在水中的溶解度為 1cc的水中可溶解0.0214cc的氫氣。100cc水中可溶解2.14cc氫氣。
氫氣是氣體，水是液體。並不容易相互溶解。溶解率較低。但是100cc的水中仍可溶解2.14cc的氫氣。因為是氣體與液體相互溶解。氣體與液體都用cc(體積)來計算與表示，才是正確的。
MitoGene
describes the manufacturing of hydrogen gas. It is produced in a reformer
device by reacting steam with natural gas at high temperatures. Trace
contaminants include oxygen, water vapor, argon, carbon monoxide, carbon
dioxide, nitrogen, and hydrocarbons. MitoGene states that food grade hydrogen
gas is manufactured at a high purity (≥99.995%) using good manufacturing
practices (GMP). All materials used in the manufacturing process of hydrogen
gas are food grade and used within accepted limits of GMP.
MitoGene intends to use hydrogen gas in flavored beverages, drinking water, and soda drinks. The highest intended use level of solubilized hydrogen gas in beverages will be 2.14% (volume (vol) H2 (gas) /vol H2O (liq)), the saturation concentration for molecular hydrogen gas in water. MitoGene includes information describing that hydrogen gas-enriched beverages are produced by introducing high purity hydrogen into the liquid medium under high-pressure conditions (~100 pounds per square inch), resulting in a product containing solubilized hydrogen gas. MitoGene states that the European Union has approved hydrogen gas as a packaging gas. MitoGene assumes a maximum daily consumption of hydrogen gas-enriched beverages to be 2 Liters/person/day (2000 g/p/day), and discusses that this will result in a hydrogen gas exposure equal to 3.2 milligrams (mg)/p/day. MitoGene將氫氣在調味飲料，飲用水，和蘇打飲料。氫氣溶解在飲料的最高預期溶解率2.14％(體積）H 2氫氣（氣體）/(體積)H 2 O水（LIQ）），氫氣在水中的飽和濃度。。MitoGene包括描述的氫富含氣體的飲料通過將高純度的氫氣，變成高壓條件下，液體介質（約100磅每平方英寸），因此，含溶解氫氣的產品產生的信息。MitoGene指出，歐盟已批准氫氣作為包裝氣體。MitoGene取最大含氫飲料為2升/人/天（2000克/人/天）……
這一段再提出來說明:
The highest intended use level of solubilized hydrogen gas in beverages will be 2.14% (volume (vol) H2 (gas) /vol H2O (liq))
氫氣溶解在飲料的最高預期溶解率2.14％(體積）H 2氫氣（氣體）/(體積)H 2 O水（LIQ）），氫氣在水中的飽和濃度。
氫氣在水中的飽和溶解度是2.14% 2.14cc氫氣/100cc水
MitoGene discusses published studies reporting on the respiratory elimination of both endogenously produced hydrogen gas as well as consumed hydrogen gas in human subjects. MitoGene summarizes a published study, which shows an acute increase in exhaled hydrogen gas after volunteers drank hydrogen gas-enriched water. Shortly thereafter, the hydrogen gas levels that were determined using the hydrogen gas breath test decreased to baseline levels. MitoGene states that from the scientific literature there is nothing of toxicological concern that would dispute its conclusion that the intended use of hydrogen gas as described in this notice is GRAS.
Standards of Identity
In the notice, MitoGene states its intention to use hydrogen gas in several food categories, including foods for which standards of identity exist, located in Title 21 of the Code of Federal Regulations. We note that an ingredient that is lawfully added to food products may be used in a standardized food only if it is permitted by the applicable standard of identity.
Potential Labeling Issues
Section 403(k) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) provides that a food shall be deemed to be misbranded if it bears or contains any chemical preservative, unless it bears labeling stating that fact. Section 403(i)(2) of the FD&C Act provides that a food shall be deemed to be misbranded unless its label bears the common or usual name of each ingredient. Section 403(a) of the FD&C Act provides that a food shall be deemed to be misbranded if its labeling is false or misleading in any particular. MitoGene’s use of hydrogen gas for the purpose of preventing oxidation constitutes use as a preservative. Therefore, the ingredient statement on labels of food products that contain hydrogen gas must comply with the labeling regulations that implement sections 403(k) and 403(i)(2) of the FD&C Act. For example, 21 CFR 101.22(j) requires that the food to which a chemical preservative is added bear a label declaration stating both the common or usual name of the ingredient and a separate description of its function. Further, food that is subjected to any form of preservation, except as provided in 21 CFR 101.95(c), may not be labeled as “fresh.” If MitoGene has any questions about the appropriate labeling of this food ingredient, MitoGene should contact the staff in the Office of Nutrition, Labeling, and Dietary Supplements (ONLDS) in the Center for Food Safety and Applied Nutrition.
In describing the intended use of hydrogen gas and in describing the information that MitoGene relies on to conclude that hydrogen gas is GRAS under the conditions of its intended use, MitoGene raises a potential issue under the labeling provisions of the FD&C Act. To conclude that hydrogen gas is GRAS, MitoGene cites efficacy studies in animals that show potential physiological effects of hydrogen gas that the notifier views as beneficial. Under section 403(a) of the FD&C Act, a food is misbranded if its labeling is false or misleading in any particular. Section 403(r) of the FD&C Act lays out the statutory framework for the use of labeling claims that characterize the level of a nutrient in a food or that characterize the relationship of a nutrient to a disease or health-related condition. If products that contain hydrogen gas bear any claims on the label or in labeling, such claims are the purview of ONLDS. The Office of Food Additive Safety neither consulted with ONLDS on this labeling issue nor evaluated the information in your notice to determine whether it would support any claims made about hydrogen gas on the label or in labeling.
Section 301(ll) of the FD&C Act
The Food and Drug Administration Amendments Act of 2007, which was signed into law on September 27, 2007, amends the FD&C Act to, among other things, add section 301(ll). Section 301(ll) of the FD&C Act prohibits the introduction or delivery for introduction into interstate commerce of any food that contains a drug approved under section 505 of the FD&C Act, a biological product licensed under section 351 of the Public Health Service Act, or a drug or a biological product for which substantial clinical investigations have been instituted and their existence made public, unless one of the exemptions in section 301(ll)(1)-(4) applies. In its review of MitoGene’s notice that hydrogen gas is GRAS for the intended uses, FDA did not consider whether section 301(ll) or any of its exemptions apply to foods containing hydrogen gas. Accordingly, this response should not be construed to be a statement that foods that contain hydrogen gas, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll).
Conclusions
Based on the information provided by MitoGene, as well as other information available to FDA, the agency has no questions at this time regarding MitoGene’s conclusion that hydrogen gas is GRAS under the intended conditions of use. The agency has not, however, made its own determination regarding the GRAS status of the subject use of hydrogen gas. As always, it is the continuing responsibility of MitoGene to ensure that food ingredients that the firm markets are safe, and are otherwise in compliance with all applicable legal and regulatory requirements.
In accordance with proposed 21 CFR 170.36(f), a copy of the text of this letter responding to GRN 000520, as well as a copy of the information in this notice that conforms to the information in the GRAS exemption claim (proposed 21 CFR 170.36(c)(1)), is available for public review and copying at www.fda.gov/grasnoticeinventory.
MitoGene intends to use hydrogen gas in flavored beverages, drinking water, and soda drinks. The highest intended use level of solubilized hydrogen gas in beverages will be 2.14% (volume (vol) H2 (gas) /vol H2O (liq)), the saturation concentration for molecular hydrogen gas in water. MitoGene includes information describing that hydrogen gas-enriched beverages are produced by introducing high purity hydrogen into the liquid medium under high-pressure conditions (~100 pounds per square inch), resulting in a product containing solubilized hydrogen gas. MitoGene states that the European Union has approved hydrogen gas as a packaging gas. MitoGene assumes a maximum daily consumption of hydrogen gas-enriched beverages to be 2 Liters/person/day (2000 g/p/day), and discusses that this will result in a hydrogen gas exposure equal to 3.2 milligrams (mg)/p/day. MitoGene將氫氣在調味飲料，飲用水，和蘇打飲料。氫氣溶解在飲料的最高預期溶解率2.14％(體積）H 2氫氣（氣體）/(體積)H 2 O水（LIQ）），氫氣在水中的飽和濃度。。MitoGene包括描述的氫富含氣體的飲料通過將高純度的氫氣，變成高壓條件下，液體介質（約100磅每平方英寸），因此，含溶解氫氣的產品產生的信息。MitoGene指出，歐盟已批准氫氣作為包裝氣體。MitoGene取最大含氫飲料為2升/人/天（2000克/人/天）……
這一段再提出來說明:
The highest intended use level of solubilized hydrogen gas in beverages will be 2.14% (volume (vol) H2 (gas) /vol H2O (liq))
氫氣溶解在飲料的最高預期溶解率2.14％(體積）H 2氫氣（氣體）/(體積)H 2 O水（LIQ）），氫氣在水中的飽和濃度。
氫氣在水中的飽和溶解度是2.14% 2.14cc氫氣/100cc水
MitoGene discusses published studies reporting on the respiratory elimination of both endogenously produced hydrogen gas as well as consumed hydrogen gas in human subjects. MitoGene summarizes a published study, which shows an acute increase in exhaled hydrogen gas after volunteers drank hydrogen gas-enriched water. Shortly thereafter, the hydrogen gas levels that were determined using the hydrogen gas breath test decreased to baseline levels. MitoGene states that from the scientific literature there is nothing of toxicological concern that would dispute its conclusion that the intended use of hydrogen gas as described in this notice is GRAS.
Standards of Identity
In the notice, MitoGene states its intention to use hydrogen gas in several food categories, including foods for which standards of identity exist, located in Title 21 of the Code of Federal Regulations. We note that an ingredient that is lawfully added to food products may be used in a standardized food only if it is permitted by the applicable standard of identity.
Potential Labeling Issues
Section 403(k) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) provides that a food shall be deemed to be misbranded if it bears or contains any chemical preservative, unless it bears labeling stating that fact. Section 403(i)(2) of the FD&C Act provides that a food shall be deemed to be misbranded unless its label bears the common or usual name of each ingredient. Section 403(a) of the FD&C Act provides that a food shall be deemed to be misbranded if its labeling is false or misleading in any particular. MitoGene’s use of hydrogen gas for the purpose of preventing oxidation constitutes use as a preservative. Therefore, the ingredient statement on labels of food products that contain hydrogen gas must comply with the labeling regulations that implement sections 403(k) and 403(i)(2) of the FD&C Act. For example, 21 CFR 101.22(j) requires that the food to which a chemical preservative is added bear a label declaration stating both the common or usual name of the ingredient and a separate description of its function. Further, food that is subjected to any form of preservation, except as provided in 21 CFR 101.95(c), may not be labeled as “fresh.” If MitoGene has any questions about the appropriate labeling of this food ingredient, MitoGene should contact the staff in the Office of Nutrition, Labeling, and Dietary Supplements (ONLDS) in the Center for Food Safety and Applied Nutrition.
In describing the intended use of hydrogen gas and in describing the information that MitoGene relies on to conclude that hydrogen gas is GRAS under the conditions of its intended use, MitoGene raises a potential issue under the labeling provisions of the FD&C Act. To conclude that hydrogen gas is GRAS, MitoGene cites efficacy studies in animals that show potential physiological effects of hydrogen gas that the notifier views as beneficial. Under section 403(a) of the FD&C Act, a food is misbranded if its labeling is false or misleading in any particular. Section 403(r) of the FD&C Act lays out the statutory framework for the use of labeling claims that characterize the level of a nutrient in a food or that characterize the relationship of a nutrient to a disease or health-related condition. If products that contain hydrogen gas bear any claims on the label or in labeling, such claims are the purview of ONLDS. The Office of Food Additive Safety neither consulted with ONLDS on this labeling issue nor evaluated the information in your notice to determine whether it would support any claims made about hydrogen gas on the label or in labeling.
Section 301(ll) of the FD&C Act
The Food and Drug Administration Amendments Act of 2007, which was signed into law on September 27, 2007, amends the FD&C Act to, among other things, add section 301(ll). Section 301(ll) of the FD&C Act prohibits the introduction or delivery for introduction into interstate commerce of any food that contains a drug approved under section 505 of the FD&C Act, a biological product licensed under section 351 of the Public Health Service Act, or a drug or a biological product for which substantial clinical investigations have been instituted and their existence made public, unless one of the exemptions in section 301(ll)(1)-(4) applies. In its review of MitoGene’s notice that hydrogen gas is GRAS for the intended uses, FDA did not consider whether section 301(ll) or any of its exemptions apply to foods containing hydrogen gas. Accordingly, this response should not be construed to be a statement that foods that contain hydrogen gas, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll).
Conclusions
Based on the information provided by MitoGene, as well as other information available to FDA, the agency has no questions at this time regarding MitoGene’s conclusion that hydrogen gas is GRAS under the intended conditions of use. The agency has not, however, made its own determination regarding the GRAS status of the subject use of hydrogen gas. As always, it is the continuing responsibility of MitoGene to ensure that food ingredients that the firm markets are safe, and are otherwise in compliance with all applicable legal and regulatory requirements.
In accordance with proposed 21 CFR 170.36(f), a copy of the text of this letter responding to GRN 000520, as well as a copy of the information in this notice that conforms to the information in the GRAS exemption claim (proposed 21 CFR 170.36(c)(1)), is available for public review and copying at www.fda.gov/grasnoticeinventory.
Sincerely,
Dennis M. Keefe, Ph.D.
Director
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Dennis M. Keefe, Ph.D.
Director
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
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