FDA CIRCULAR  
No. ___________  
  
SUBJECT  : Guidelines for the Authorization of Vaporized Nicotine and Non -
Nicotine Products and Novel Tobacco Products with Medicinal 
or Therapeutic Claims or Reduced Risk  Statements Pursuant to 
Sections 12 (k), 12 (l), and 13 (c) of Republic Act No. 11900  
_____________________________________________________________________________  
 
I. RATIONALE  
 
Sections 12 (k), 12 (l), and 13 (c) of R epublic Act (R A) No. 11900  and its 
implementing rules and regulations (IRR)  issued through Department 
Administrative Order No. 22 -16, vaporized nicotine and non -nicotine products 
(VNNPs ) and novel tobacco products ( NTPs ) bearing explicit medicinal or 
therapeutic claims, or reduced risk  statements shall require approval from the Food 
and Drug Administration (FDA) pursuant to RA No. 9711 otherwise known as the 
“Food and Drug Regulation Act of 2009”.  
 
RA No. 11900 defines medicinal or therapeutic claims as “explicit statements 
made on any product presented as having properties for directly treating, curing, 
alleviating, or preventing diseases or disorders in persons” whereas reduced risk 
statements are defined as “explicit communication to consumers in the product 
label or marketing materials which states that the product presents less risk of harm 
to the user's health or is less harmful to the user's health than continued smoking 
of combustible cigarett es”.  
 
For products intended to reduce the risk of smoking -related diseases,  the FDA 
notes that  it should be able to assist users in quitting  traditional  cigarettes  
altogether . As such , VNNPs and NTPs  intended to  reduce the  risk of smoking -
related harm sh all be primarily  considered as  smoking cessation aid  with a 
secondary claim for reduced risk . 
 
Thus, under FDA’s current regulatory framework, VNNPs and NTPs under the 
jurisdiction of the FDA pursuant to RA No. 11900  shall  be regulated as 
pharmaceutical  products .  
 
 
II. OBJECTIVE   
 
This issuance aims to provide the  guidelines for the  regulation of  VNNPs and 
NTPs that are marketed with medicinal or therapeutic claims or reduced risk  
statements  pursuant to RA No. 9711 and RA No. 11900 and their IRRs, and other 
pertinent laws, rules, and regulations.   
 
  
 III. SCOPE AND COVERAGE  
 
This issuance shall co ver all establishments engaged or intending to engage in the 
manufacture, importation , export ation, sale, offering for sale, distribution, transfer, 
promotion, advertising, and/or sponsorship of VNNPs and NTPs with medicinal 
or therapeutic claims on its marketing materials or packaging . This shall also apply 
to VNNPs and NTPs used as smoking cessation aids wi th a secondary claim of 
reduced risk . 
 
 
IV. DEFINITION OF TERMS  
 
To establish clarity and uniformity in the implementation of this Circular, the 
following terms are hereby defined:  
 
A. Authorization -  refers to a permission embodied in a document granted by 
the FDA to a natural or juridical person who has submitted an application to 
implement the manufacture, importation, exportation, sale, offer for sale, 
distribution, transfer, and/or, where appropri ate, the use, testing, promotion, 
advertising, or sponsorship of vaporized nicotine and non -nicotine product or 
novel tobacco product. The authorization can take the form of a permit, a 
license, a certificate of registration, of accreditation, of complianc e, or of 
exemption, or any similar document.  
 
B. Distributor -Importer/Exporter  – refers to  any establishment that imports 
or exports raw materials, active ingredients and/or finished products for its 
own use or for wholesale distribution to other establishmen ts or outlets. If the 
distributor/importer/exporter sells to the general public, it shall be considered 
a retailer.  
 
C. Distributor -Wholesaler  – refers to  any establishment that procures raw 
materials, active ingredients and/or finished products from local 
establishments for local distribution on wholesale basis.  
 
D. Establishment - refers to a sole proprietorship, a partnership, a corporation, 
an institution,  an association, or an organization engaged in the manufacture 
or importation, offer for sale, distribution, donation, transfer, use, testing, 
promotion, advertising, or sponsorship of tobacco products including the 
facilities and installations needed for its activities.  
 
E. Heated Tobacco Products (HTPs)  - also referred to as Heated Tobacco 
Product (HTP) Consumables or Heat -Not-Burn Product Consumables, shall 
refer to tobacco products that are intended to be consumed through heating 
tobacco, either electronically or through other means, sufficient to rele ase an 
aerosol that can be inhaled, without combustion of the tobacco. HTP 
Consumables or Heat -Not-Burn Product Consumables may also include  
 liquid solutions and gels that are part of the product and are heated to generate 
an aerosol. HTPs may or may not o perate by means of an HTP Device;  
 
E. Manufacturer - refers to an  establishment engaged in any and all operations 
involved in the production of vaporized nicotine and non -nicotine product or 
novel tobacco product including preparation, processing, compounding, 
formulating, filling, packing, repacking, altering, ornament ing, finishing, and 
labeling with the end in view of its storage, sale or distribution: Provided, that 
the term shall not apply to the compounding and filling of prescriptions in 
drugstores and hospital pharmacies. A trader shall be categorized as a 
manufa cturer.  
 
F. Medicinal or Therapeutic Claims - refers to explicit statements made on 
any product presented as having properties for directly treating, curing, 
alleviating, or preventing diseases or disorders in persons;  
 
G. Novel Tobacco Products (NTPs) - refers to all non -combusted substances in 
solid or liquid form, and innovations, either made partly of tobacco leaf as 
raw material or containing nicotine from tobacco, intended to be used as a 
substitute for cigarettes or other combusted tobacco products;  
 
H. Produ ct – refers  to VNNPs and NTPs as defined in this issuance.  
 
I. Post-Marketing Surveillance (PMS) - refers to activities involved in safety, 
efficacy, and quality monitoring of regulated products and establishments. 
This shall also include, among others, adverse events reporting, product safety 
update reporting, collection and testing of vaporized nicoti ne and non -
nicotine product or novel tobacco product  in the market.  
   
J. Reduced Risk Statement - refers to an explicit communication to consumers 
in the product label or marketing materials which states that the product 
presents less risk of harm to the user's health or is less harmful to the user's 
health than continued smoking of combustible cigare ttes; 
 
K. Retailer  – refers to  any establishment which sells or offers to sell any health 
product directly to the general public."  
 
L. Trader - refers to an establishment that is a registered owner of a vaporized 
nicotine and non -nicotine product or novel tobacco product , procures the raw 
materials and packing components, provides the production, monographs, 
quality control standards, and procedures, but subcontracts the manufacture 
of such a product to a licensed Manufacturer. In addition, a trader may als o 
engage in the distribution and/or marketing of its products.  
 
M. Vapor Products  - also referred to as Vapor Product Refills, refer s to the 
liquid, solid, or gel, or any combination thereof, which may or may not  
 contain nicotine, that is transformed into an aerosol without combustion by a 
Vapor Product Device  
 
N. Vaporized Nicotine or Non -Nicotine Products  (VNNPs) - refers to both 
Heated Tobacco Products and Vapor Products, as defined herein, which are 
novel consumer goods that generate a nicotine -containing or non -nicotine -
containing aerosol without combustion.  
 
 
V. GENERAL GUIDELINES  
 
A. The manufacture, importation, exportation, sale, offer for sale, distribution, 
transfer, and/or, the use, testing, promotion, advertising, or sponsorship of 
VNNPs and NTPs without License to Operate (LTO) covered in this issuance 
is prohibited.  
 
B. Establishments of VNNPs and  NTPs with in the scope of this issuance  shall 
secure a Certificate of Product Registration for the products they intend to 
market in the country.  
 
C. Only FDA approved claims  shall be placed or used on the  label, packaging or 
marketing materials and activities of the VNNPs and NTPs . No VNNPs and 
NTPs that has not been registered or authorized  shall be advertised, promoted 
or subjected to any marketing activities . 
 
D. No claim in the advertisement, promotion and sponsorships, express 
communication and other marketing activities shall be made other than those 
contained in the approved label or packaging or advertising of VNNPs and 
NTPs.  
 
E. Only scientifically proven claims and statements shall be authorized or 
approved by the FDA.  
 
F. VNNP and NTP establishments shall ensure continuous and strict compliance 
with existing FDA laws, rules, regulations and applicable standards and 
conditions set forth, and coordinate with the agency on matters of post -
marketing surveillance (PMS) including but not limited to adverse event 
reporting and product recalls.   
 
G. VNNP and NTP establishments and their products shall be subject to 
inspection by FDA inspectors during office hours as part of the Agency’s  pre-
licensing  and/or post-marketing surveillance activities.  
 
 
   
 VI. SPECIFIC GUIDELINES  
 
A. Licensing  and Inspection  of VNNP and NTP Establishments  
 
1. Establishments within the scope of this issuance shall secure their 
License to Operate (LTO) following the current implemented  Citizen’s 
Charter (CC) for pharmaceutical products as posted in the official 
website of the FDA . 
 
2. Inspection conducted by FDA inspectors for the purpose of issuance of 
LTO or part of the agency’s post -marketing surveillance activities shall 
be based on a pplicable standards established for pharmaceutical  
establishments . 
 
B. Product Registration  
 
1. Products  under the scope of this issuance  shall be registered  with the 
following the guidelines  for pharmaceutical products provided in the 
current implemented CC as posted in the official website of the FDA . 
 
2. Products which are authorized, validated, accepted, or permitted by 
reliable and mature national regulatory agencies to be marketed with 
the same classification and function /indication shall be taken into 
conside ration by the FDA in its resolution of an application for an 
authorization and shall be resolved within eighteen (18) months.  
 
3. Products which are recalled, withdrawn, or banned in the jurisdiction 
of the aforesaid reliable and mature national regulatory agencies taken 
into consideration by the FDA shall be automatically recalled, 
withdrawn, or banned in the country.  Pending applications for 
registration of products that are subject of ban, recall, or withdrawal 
from their countries of origin shall be auto matically rejected without 
prejudice to the refiling of the applications with a clear showing that 
the order for such ban, recall or withdrawal from the market has been 
lifted without conditions.  
 
C. Post-Marketing Surveillance  
 
1. VNNP and NTP establishments and their products issued with the 
appropriate authorizations shall be subject to the FDA’s post -
marketing surveillance activities  following the current implemented 
FDA CC as posted in the official website of the FDA .  
 
 
   
 VII. MANDATORY REVIEW  
 
This iss uance shall be reviewed three (3 ) years after its implementation date or 
earlier as may be necessary  to update  the current regulatory framework.  
 
 
VIII.  PENALTIES  
 
Violation to any provisions of this issuance shall be subject to the 
penalties/sanctions provided under Book III, Article XI of the Rules and 
Regulations Implementing Republic Act No. 9711, The Food and Drug 
Administration Act of 2009, Republic Act No. 11900, the Vaporized Nicotine and 
Non-Nicotine Products Regulations Act, and its implementing rules and 
regulations, and other penalties provided by other applicable laws.  
 
 
IX. SEPARABILITY CLAUSE  
 
If any provision in this issuance, or application of such provision to any 
circumstances, is held invalid, the remainder of the provisions in this issuance shall 
not be  affected.  
 
 
X. EFFECTIVITY  
 
This issuance shall take effect fifteen (15) days after publication to the Official 
Gazette or a newspaper of general circulation, with three (3) copies to be filed with 
the U.P. Law Center pursuant to Section 3, Chapter 3, Book VII of Executive Order 
No. 292, Series of 1987 through this Department’s records officer or its equivalent 
functionary . 
  
 
 
DR. SAMUEL A. ZACATE  
Director General  
 
 
Office  CDRR  PPS 
Initials   
 
JESUSA JOYCE N. CIRUNAY  
Director IV   
 
IRENE V. FLORENTINO -FARIÑAS, RPh, MD, MNSA  
Director III 
Date