Month: February 2019

PROHIBITED AND RESTRICTED INGREDIENTS IN COSMETICS

FDA Registration for Cosmetic Products and Cosmetic Establishments is voluntary and FDA does not approve cosmetic products or ingredients before they go on the market. It is the responsibility of cosmetic manufacturer to ensure the safety of its products.

As per FD&C, it is prohibited by law to distribute any cosmetic containing an ingredient that makes the product harmful when used exactly as per label directions or as per the customary use. The only exception to this rule is for coal tar hair dyes for which FDA cannot take action against as long as the product label contains a special warning statement and also contains directions for a skin test.

Color additives are permitted in cosmetics only if FDA has pre-approved them for the intended use.

FDA specifically prohibits or restricts following ingredients in cosmetics:

  • Bithionol – Prohibited as it may cause photo contact sensitization
  • Chlorofluorocarbon propellants – Prohibited for use in cosmetic aerosol products intended for domestic consumption
  • Chloroform – Prohibited as it causes cancer in animals and is likely to be harmful to human health, too. Except for residual amounts from its use as a processing solvent during manufacture, or as a byproduct from the synthesis of an ingredient
  • Halogenated salicylanilides (di-, tri-, metabromsalan and tetrachlorosalicylanilide) – Prohibited as it may cause serious skin disorders.
  • Hexachlorophene – Prohibited because of its toxic effect and ability to penetrate human skin. The HCP concentration in a cosmetic may not exceed 0.1 percent, and it may not be used in cosmetics that are applied to mucous membranes, such as the lips
  • Mercury compounds – Restricted to eye area products at no more than 0.0065 percent of mercury calculated as the metal and is permitted only if no other effective and safe preservative is available
  • Methylene chloride – Prohibited as it causes cancer in animals and is likely to be harmful to human health, too
  • Prohibited cattle materials – These materials include specified risk materials, material from no ambulatory cattle, material from cattle not inspected and passed, or mechanically separated beef
  • Sunscreens in cosmetics
  • Vinyl chloride – Prohibited for use as an ingredient of aerosol products, because it causes cancer and other health problems
  • Zirconium-containing complexes – Prohibited in aerosol cosmetic products because of their toxic effect on lungs of animals, as well as the formation of granulomas in human skin

FDA may take action against any such cosmetic manufacturers or products on the market that do not comply with the law.

Cosmetic labels must always carry directions for use as some cosmetics are safe when used the correct way and unsafe when used the wrong way. Cosmetics must have any directions for use or warning statements needed to make sure people use the products safely. For example; some ingredients are safe on skin if washed off immediately but not if left on skin for hours or some ingredients that are safe for use on hair but not safe when used near eyes.

Liberty Management Group LTD  is one of the leading FDA consulting group in the USA. LMG provides assistance with Registrations, Label compliance, and many more FDA regulations.

Namrata

FDA Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on February 27, 2019

FSMA – PRODUCE SAFETY RULE

As per FDA about 48 million people get sick, 128000 are hospitalized and 3000 die every year from food borne illnesses. FSMA (Food Safety Modernization Act) was signed into law in 2011 by President Obama to reform America’s food safety system. It enables FDA to focus on preventing food problems rather than reacting to problems after they have already occurred.

To implement FSMA, FDA has finalized seven major rules which recognize that ensuring food safety is a shared responsibility among various points in the global supply chain for both human and animal food. One of the rules that takes care of farms is Produce Safety Rule, officially known as Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption.

Produce Safety Rule established science-based standards for safe growing, harvesting, packing and holding of fruits and vegetables grown for human consumption. The rule lays down preventative measures that would help bring significant benefits to consumers. The measures take care of:

  • Agricultural water
  • Farm workers training on health and hygiene
  • Biological soil amendments
  • Domesticated and wild animals’ control
  • Equipment, tools and building
  • Sprouts

Food safety risk is high for certain foods example leafy vegetables. In November 2018, several warnings were issued to consumers to avoid eating lettuce in US, as there was an E. coli outbreak linked to it, while there were investigations ongoing.

FDA has provided various compliance dates depending on the size of producer and type of produce.

FDA will begin routine inspections of large farms, other than sprouts operations, in spring 2019. The routine inspection of small farms will begin in spring 2020.

Farmers may refer to the draft guidance created by FDA to know how these requirements can be met.

Liberty Management Group LTD  is one of the leading FDA consulting group in the USA. LMG provides assistance with various FDA regulations.

Namrata

FDA Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on February 20, 2019

What are Food Additives?

Food Additives are substances the intended use of which results or may be expected to result, directly or indirectly, in its becoming a component of any food.

Direct Food Additives are any substances that are intentionally added to food to enhance or preserve its taste, texture, nutrition or appearance.

FDA registration is required for all domestic and foreign facilities that manufacturer, pack, label and store food additives. In addition all foreign facilities must also designate a US Agent for the purpose of FDA registration.

All food additives are deemed unsafe and are subject to premarket approval by FDA unless the substance is GRAS (Generally Recognized As Safe).

It is the responsibility of the food manufacturers to make sure that all ingredients in his products are approved and are used within the permissible limits of law. The regulatory status of a food is affected by the regulatory status of each food ingredient. The authorization is determined by the identity, properties and limitations of use. The regulatory status may be checked at the FDA website.

Food additives can be of various kinds such as; pH Control Agents, Anti-caking Agents, Emulsifiers, Humectants, Stabilizers, Thickeners and Gelling Agents, Leavening Agents etc.

To market a new food additive or before using an additive already approved for one use in another manner that is not yet approved, a manufacturer or other sponsor must either submit a Food Additive Petition or submit GRAS notification.

A Food Additive Petition is either approved or denied by FDA. If an additive is approved, FDA issues regulations that may include the types of foods in which it can be used, the maximum amounts that can be used, and how it should be appear on food labels.

Alternatively, a manufacturer may choose to go with GRAS notification. Under GRASN, a company notifies FDA that a particular use of a substance has been determined to be GRAS and provide the same type and quality of data to the agency as in the FAP process. FDA reviews the notification data but there is neither approval not denial.

Liberty Management Group LTD  is one of the leading FDA consulting group in the USA. LMG provides assistance with FDA registrations, Label Review and many more FDA regulations.

Namrata

FDA Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on: February 14, 2019

Why is Prior Notice important?

Prior Notice is a notification issued to FDA prior to the importation of an article of food for human or animal consumption into USA. This includes 50 US states, District of Columbia, Puerto Rico only. The US territories are not covered under this definition.

Food that is imported with inadequate Prior Notice is subject to refusal and detention at the port of entry.

For Prior Notice, food includes all foods for human or animal consumption, irrespective of intended use.

Prior Notices are considered inadequate:

  • When there is either no prior notice submitted, or
  • The information submitted in prior notice is inaccurate, or
  • The prior notice is not submitted in accordance with required timeframes.

The requirement for prior notice is not based on the requirement of FDA registration. FDA registration is required for facilities that are engaged in manufacturing, processing, packing or holding of food for consumption in USA. Prior Notice is required for articles of food imported into US.

There are two online systems available that may be used to file Prior Notices namely., FDA’s PNSI and CBP’s ABI/ACS. For a prior notice submitted via CBP’s ABI/ACS, you may not submit prior notice more than 30 calendar days before the anticipated date of arrival. For a prior notice submitted via the FDA’s PNSI, you may not submit prior notice more than 15 calendar days before the anticipated date of arrival.

The requirement of Prior Notice does not apply to:

  • Food for personal use that accompanies the individual.
  • Home made food sent as personal gift to another individual in US.
  • Food that is imported & then exported and doesn’t not leave the port of arrival.
  • Meat and Poultry food products regulated exclusively by USDA.
  • Food brought in diplomatic bags.

Any person with knowledge of the required information may submit prior notice for an article of food being imported.

Timeframes for submitting Prior Notice:

For foods arriving by international mail –

  • For foods arriving by road, 2 hours before arrival;
  • For foods arriving by rail or by air, 4 hours before arrival;
  • For foods arriving by water, 8 hours before arrival

For foods arriving by Express Couriers like FEDEX – before the food is sent

Liberty Management Group LTD  is one of the leading FDA consulting groups in the USA. LMG provides assistance with Prior Notice, FDA registration and other FDA regulations.  

Namrata

FDA Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on: February 06, 2019