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The FDA has warned establishments against selling these products.
“All concerned establishments are warned not to distribute violative food products until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a CPR for the food products,” according to the FDA.
They also advised the public to always check if a food product or food supplement is registered with the FDA through their website (www.fda.gov.ph).—AAC
MANILA, Philippines – The Food and Drug Administration (FDA) is calling on hospitals under the Department of Health (DOH) to report any cases of illness or injury related to the use of electronic cigarettes (e-cigarette) and vaping amid rising number of such cases in other countries.
“The FDA requests all DOH-retained hospitals to immediately communicate relevant case reports of injuries and illnesses documented arising from the use of these devices,” the agency said in an advisory.
The FDA said this is in the interest of evidence-based policy development, and in line with the emerging report of electronic cigarette-related injury and illnesses from Europe and North America.
The agency said the use of electronic nicotine and non-nicotine delivery systems (ENDS/ENNDS) are under the purview of the agency based on Republic Act 9711, the FDA said.
“In compliance with the Data Privacy Act of 2012, it is expected that the information provided will be anonymized in as much as they are thorough and extensive,” the agency said.
As of August 27, U.S. health authorities have monitored 215 possible cases of pulmonary illnesses, all patients have reported using e-cigarette products.
According to the USCDC, e-cigarettes can contain harmful or potentially harmful substances, including nicotine, heavy metals such as lead, volatile organic compounds, and cancer-causing chemicals.
Additionally, some e-cigarette products are used to deliver illicit substances, which may be acquired from unknown or unauthorized sources.
“Based on reports from several states, patients have experienced respiratory symptoms (cough, shortness of breath, or chest pain), and some have also experienced gastrointestinal symptoms (nausea, vomiting, or diarrhea) or non-specific constitutional symptoms (fatigue, fever, or weight loss). Symptoms typically develop over a period of days but sometimes can manifest over several weeks,” the advisory stated.
The USCDC have recommended some steps for clinicians, including the reporting of cases of severe pulmonary disease of unclear etiology and history of e-cigarette use within the past 90 days, to help determine the cause of these sicknesses.
The World Health Organization (WHO) earlier said the use of e-cigarettes should be regulated as there is no evidence proving they were a safer alternative to cigarettes, warning that it normalizes smoking and hooks young people.
MANILA, Philippines – The Food and Drug Administration (FDA) has advised Mead Johnson Nutrition to voluntary recall Lactum Instant Formula Powder for 0-6 Months, with batch no. PL9GDL5B, manufactured on July 12, 2019 and expiration date of January 12, 2021.
The recall order was due to a difference in the actual product inside the box.
According to the FDA, manufacturer Mead Johnson Nutrition received a report from their authorized retailer that there was a discrepancy between the product marked in their storage and the actual product.
The affected batch contained LACTUM Infant Formula Powder 6-12 Months, intended for infants aged 6-12 months, the FDA noted.
Thus, the agency advised the public to stop feeding their infants 0-6 months of the recalled batch as this may cause dehydration and electrolyte imbalance due to the formulation being intended for infants aged 6-12 months.
Likewise, there is a greater risk for Cronobacter sakazakii infection for infants under two months of age as the inappropriate formulation inside.
Mead Johnson Nutrition has decided to proceed with the recall of product batch no. PL9GDL5B though the firm has not received any adverse event reports for this incident.
Consumers who may have purchased the above product are advised to contact Mead Johnson Nutrition Center hotline at telephone number 841-8222 of email the FDA at firstname.lastname@example.org for information on how to obtain either a replacement product or full refund.
In line with this, the agency ordered all of its Field Regulatory Operations Office (FROO) “to monitor the availability of the product with the specified batch number in the market and instruct the concerned establishment to return the sealed stocks to Mead Johnson Nutrition for proper disposal.”
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