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Barry Harrison
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TL;DR: In the US and the EU, vaccine manufacturers are required to disclose all ingredients within the vaccine on vaccine packaging inserts available online alphabetically and European public assessment reports searchable through a database, respectively. In both regions, quantities of some ingredients (active ingredients, adjuvants, and absorbents) must also be disclosed. However, the US requires disclosure of all quantities of all vaccine ingredients while the EU doesn't.

TL;DR: In the US and the EU, vaccine manufacturers are required to disclose all ingredients within the vaccine on vaccine packaging inserts available online alphabetically and European public assessment reports searchable through a database, respectively. In both regions, quantities of some ingredients (active ingredients, adjuvants, and absorbents) must also be disclosed. However, the US requires disclosure of all vaccine ingredients while the EU doesn't.

TL;DR: In the US and the EU, vaccine manufacturers are required to disclose all ingredients within the vaccine on vaccine packaging inserts available online alphabetically and European public assessment reports searchable through a database, respectively. In both regions, quantities of some ingredients (active ingredients, adjuvants, and absorbents) must also be disclosed. However, the US requires disclosure of all quantities of all vaccine ingredients while the EU doesn't.

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Barry Harrison
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As I just dug up the textbook ~20 minutes ago, I do not have enough time to resolve this apparent contradiction in law. Potentially, the CFR and the FD&C Act can conflict when a trade secret prevents disclosure of an ingredient. I will askhave asked this on Law.SELaw.SE and will update this answer later.

As I just dug up the textbook ~20 minutes ago, I do not have enough time to resolve this apparent contradiction in law. Potentially, the CFR and the FD&C Act can conflict when a trade secret prevents disclosure of an ingredient. I will ask this on Law.SE and update this answer later.

As I just dug up the textbook ~20 minutes ago, I do not have enough time to resolve this apparent contradiction in law. Potentially, the CFR and the FD&C Act can conflict when a trade secret prevents disclosure of an ingredient. I have asked this on Law.SE and will update this answer later.

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Barry Harrison
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Note regarding the textbook image: The textbook mentioned in the claim in the question does indeed exist. Additionally, the underlined sentence is real. We can check this on Google Books. Page 77 of the book clarifies this.

The Food, Drug and Cosmetic Act (Section 502[e][1][A][iii]) states that all inactive ingredients should be noted in labeling; it also states that this requirement is not necessary if trade secret information would be disclosed. The CFR additionally notes that an inactive ingredient should be listed in the labeling if the ingredient's presence is considered a safety factor (21 CFR 610.61[n]). In some cases, even in the absence of any evidence that a particular material might pose a safety factor, manufacturers have elected to disclose the presence of residual materials such as detergents, solvents, and chelating agents (see Table 6-2 for examples of manufacturing residuals).

The CFR law has been quoted earlier. Following is the relevant excerpt from the Food, Drug, and Cosmetic Act (FD&C Act).

(iii) the established name of each inactive ingredient listed in alphabetical order on the outside container of the retail package and, if determined to be appropriate by the Secretary, on the immediate container, as prescribed in regulation promulgated by the Secretary, except that nothing in this subclause shall be deemed to require that any trade secret be divulged, and except that the requirements of this subclause with respect to alphabetical order shall apply only to nonprescription drugs that are not also cosmetics and that this subclause shall not apply to nonprescription drugs not intended for human use.

As I just dug up the textbook ~20 minutes ago, I do not have enough time to resolve this apparent contradiction in law. Potentially, the CFR and the FD&C Act can conflict when a trade secret prevents disclosure of an ingredient. I will ask this on Law.SE and update this answer later.

My interpretation is: If the trade secret impacts safety, it must be disclosed. If the trade secret does not impact safety, it does not have to be disclosed. As such, the quote from the textbook "Some information regarding additives and residuals is considered to be a trade secret and thus confidential, and cannot be discussed in this chapter." is taken out of context. Such trade secrets can only be kept when there is no impact on safety. Again, I will update this answer later.


Note regarding the textbook image: The textbook mentioned in the claim in the question does indeed exist. Additionally, the underlined sentence is real. We can check this on Google Books. Page 77 of the book clarifies this.

The Food, Drug and Cosmetic Act (Section 502[e][1][A][iii]) states that all inactive ingredients should be noted in labeling; it also states that this requirement is not necessary if trade secret information would be disclosed. The CFR additionally notes that an inactive ingredient should be listed in the labeling if the ingredient's presence is considered a safety factor (21 CFR 610.61[n]). In some cases, even in the absence of any evidence that a particular material might pose a safety factor, manufacturers have elected to disclose the presence of residual materials such as detergents, solvents, and chelating agents (see Table 6-2 for examples of manufacturing residuals).

The CFR law has been quoted earlier. Following is the relevant excerpt from the Food, Drug, and Cosmetic Act (FD&C Act).

(iii) the established name of each inactive ingredient listed in alphabetical order on the outside container of the retail package and, if determined to be appropriate by the Secretary, on the immediate container, as prescribed in regulation promulgated by the Secretary, except that nothing in this subclause shall be deemed to require that any trade secret be divulged, and except that the requirements of this subclause with respect to alphabetical order shall apply only to nonprescription drugs that are not also cosmetics and that this subclause shall not apply to nonprescription drugs not intended for human use.

As I just dug up the textbook ~20 minutes ago, I do not have enough time to resolve this apparent contradiction in law. Potentially, the CFR and the FD&C Act can conflict when a trade secret prevents disclosure of an ingredient. I will ask this on Law.SE and update this answer later.

My interpretation is: If the trade secret impacts safety, it must be disclosed. If the trade secret does not impact safety, it does not have to be disclosed. As such, the quote from the textbook "Some information regarding additives and residuals is considered to be a trade secret and thus confidential, and cannot be discussed in this chapter." is taken out of context. Such trade secrets can only be kept when there is no impact on safety. Again, I will update this answer later.


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