Is Asin Law applicable for Manju Oishi?

What is the relation of Republic Act no 8172 to R.A 9711? And how should the circular of the Department of Health vis-a-vis any issuance of the Food and Drugs Administration concerning the issue be interpreted.

The former law is known as Asin law or “An Act Requiring Salt Iodization Nationwide and for related purposes”. The latter is FDA Act of 2009 or  “An Act Strengthening and Rationalizing the Regulatory Capacity of the Bureau of the Bureau of Food and Drugs (BFAD) by Establishing Adequate Testing Laboratories and Field Offices, Upgrading its Equipment, Augmenting its Human Resource Complement, Giving Authority to Retain its Income, Renaming it to Food and Drugs Administration (FDA), Amending Certain Sections of Republic Act no. 3720, as Amended, and Appropriating Funds Thereof”.

In case of conflict in the implementation of the above laws, how should it be resolved? The case in point is the cancellation of issuance by FDA of letter or certificate for release for imported salt prior to release by the Bureau of Customs under FDA Circular 2013-032. Under the said Circular, the imported salt shall be immediately released by Bureau of Customs by merely presenting LTO and/or CPR, without a letter or certificate for release from FDA. It states as follows:

i.Raw materials such as food ingredients and food additives that are imported by FDA-licensed food establishments for their own use, the License to Operate shall be presented or submitted to the Bureau of Customs.

ii.Food ingredients and food additives, among other raw materials, that are intended for distribution or for sale, the License to Operate and the Certificate of Product Registration shall be submitted to the Bureau of Customs”.

This is contrary to Rule IV, Section 6 of the Revised Implementing Rules and Regulations of R.A 8172 issued by the Department of Health, which requires the FDA to issue first a letter or certificate for release before the imported salt be released by the Bureau of Customs. Will the FDA rules prevail over the said provision?

This is answered by R.A 9711, as follows:

First, R.A 9711 defines ‘food’ under Section 9, par. e as follows:

(e) ‘Food’ means any processed substance which is intended for human consumption and includes drink for man, beverages, chewing gum and any substances which have been used as an ingredient in the manufacture, preparation or treatment of food.

Secondly, Section 25 of R.A 9711 provides as follows:

Section 25. Coverage. – This Act shall govern all health products: Provided, That nothing in this Act shall be deemed to modify the sole and exclusive jurisdiction of other specialized agencies and special laws only insofar as the acts covered by these specialized agencies and laws, including, but not limited to, those covered by Republic Act No. 9211, Executive Order No. 245, Executive Order No. 18, and Presidential Decree No. 1468.

It follows therefore that the imported salt, which maybe for food or industrial purposes, would not fall strictly under the definition of food under RA 9711. Also, being covered by special law, it is deemed excluded from the coverage of R.A 9711 and therefore not solely under the jurisdiction of FDA.

On the other hand, Section 11 of R.A 8172 gives the Department of Health its rule making power. It states as follows:

Section 11. Implementing rules and regulations.-The DOH in cooperation with the agencies concerned shall formulate the necessary rules and regulations for the effective implementation of this act within sixty (60) days from its approval.

Based on the foregoing premises, the Food and Drugs Administration, which is mandated under the Revised Implementing Rules and Regulations of Republic Act no. 8172 to issue a letter or certificate for release for imported salt, is still mandated to do the same prior to release by the Bureau of Customs. In other words, the FDA Acting Director General can not amend the administrative issuance of the Department of Health as he has no authority that is stated under the law.

Attachments:

• FDA Memorandum Circular no. 2013-032
• Revised Implementing Rules and Regulations of R.A 8172

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