Namrata – Page 5 – FDA Support

ISO 9001

ISO 9001 is the international standard for a Quality Management System (QMS) laid out by the International Organization for Standardization. The standard is implemented by organizations to demonstrate that their products and services meet regulatory requirements.

An organization may choose to implement 9001 for its entire operations or for a particular operation or department.

ISO 9001 can be implemented in all types of industries, small or large, service or manufacturing industry. ISO 9001 is process based standard. It does not define quality of products. It helps streamline the processes that must be followed to obtain desired outcome.

Some benefits of becoming ISO 9001 certified are:

Improved quality of products or services
Defined roles, responsibilities and guidelines that are easy to follow for everyone in the organization thus clarity to the employees
Better financial performance
Minimum scope for errors as everything is documented
Constant improvement in processes
Improved credibility of business

Some companies obtain an ISO certification as it improves their chances to bag business opportunities. Others may obtain a certification just to improve their business processes.

Liberty Management Group Ltd can help organizations with ISO 9001 right from documentation to implementation to certificate issuance. A certificate could be from an accredited or a non-accredited certification body depending upon the choice of companies.

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on: September 11, 2019

ALPHA HYDROXY ACIDS

AHA are used in some cosmetics and drug products applied to the skin. Cosmetic products containing AHAs are marketed for a variety of purposes, such as smoothing fine lines, improving skin texture and tone, unblocking pores etc. AHA containing products cause exfoliation or shedding of the surface skin. The extent of exfoliation depends on the concentration of AHA and other ingredients in the product.

Some products that contain high concentration of AHAs or other acids act as skin peelers. Such products are regulated as drugs by FDA. For example, acne treatment products or skin lighteners are considered drugs. FDA has received many adverse reports for AHA containing products listing adverse reactions such as skin burning, peeling, rash, swelling, blisters, increased sunburn etc. FDA has found that applying AHAs to skin results in increased UV sensitivity.

FDA recommends using AHA containing products strictly according to the label directions. It is advisable to use skin protection. FDA also recommends that the labeling of a cosmetic product bear a statement that conveys the following information:

Sunburn Alert: This product contains an alpha hydroxy acid (AHA) that may increase your skin’s sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards.

Liberty Management Group Ltd can help you make sure all elements of your product label are compliant to FDA regulations. LMG provides a wide range of services assisting companies with label compliance, ingredient compliance, FDA registration etc.

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FDA Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on: August 29, 2019

CBD in Foods and Dietary Supplements

There has been growing interest in the development of consumer products derived from cannabis and its components including CBD-Cannabidiol. FDA has found that many companies are marketing products containing CBD that may put consumers health at risk.

By far FDA has approved only one drug containing CBD for treatment of seizures. But FDA has found that many other CBD containing products are being sold in market, some as dietary supplements. As per FD&C Act, if a substance is an active ingredient (such as THC or CBD) in a drug that has been approved by FDA or is the subject of an IND – Investigational New Drug, for which substantial investigations have been instituted, then products containing such substance are excluded from the definition of dietary supplements. Exclusion from the definition of dietary supplement means that it is prohibited to market such products as dietary supplements.

If a product contains ingredients from such a part of cannabis plant that does not contain THC or CBD, then it may be marketed as a dietary supplement however it must comply with all applicable laws and regulations governing dietary supplement products. Such manufacturers who wish to market dietary supplement that contain new dietary ingredients that were not marketed in US before October 15, 1994 must notify FDA about these ingredients demonstrating that such supplement is safe under the conditions of recommended usage suggested in the labeling. In addition to NDI-New Dietary Ingredient notification, compliance to labeling and cGMP requirements specific to dietary supplements must be met.

If a non-THC or non-CBD ingredient derived from a cannabis plant is added to food products, such food ingredients are subject to premarket review and approval by FDA unless the substance is GRAS -Generally Recognized as Safe, by the experts under the conditions of its intended use. FDA has so far received and accepted only 3 GRAS notifications for hemp seed ingredients. Food companies that wish to use cannabis derived ingredients in their food products must abide by the laws and regulations including food additive petitions and GRAS notifications.

It is important to know the regulatory status of an ingredients that is added to any food or supplement. Liberty Management Group Ltd. can help you with Ingredient compliance, FDA registration, Label compliance and other FDA regulations.

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FDA Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on: August 14, 2019

Cosmetics vs Drugs

Cosmetics are defined by FD&C Act as articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance. For example, skin moisturizers, perfumes, lipsticks, fingernail polishes, cleansing shampoos, hair colors, and deodorants etc.

Drugs, on the other hand, are defined as articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and articles (other than food) intended to affect the structure or any function of the body of man or other animals.

Some products meet the definition of both cosmetic and drugs. For example, a cleansing shampoo is a cosmetic as its intended use is to cleanse the hair. An antidandruff treatment is a drug as its intended use is to treat dandruff. As a result, an antidandruff shampoo would fall under both cosmetic as well as drug. Another example is that of a toothpaste with fluoride, anti-perspirant deodorants, moisturizer with sun protection claims.

A product’s intended use is determined based on either the claims made on the label, advertisements, company website, general perception about the product in consumers mind or by the ingredients present in the product.

The FDA requirements of cosmetics and drugs are different. Below is an outline of the key differences:

FDA approval – FDA does not approve cosmetics except for color additives. On the other hand, every new drug needs an approval or conformity to FDA’s OTC monograph.
GMP – FDA has no set regulations for cosmetic GMP. There are only guidelines that cosmetic companies need to refer to. But for drug companies, FDA has laid clear regulations that drug companies need to comply with.
FDA registration – Cosmetic registrations are voluntary. Drug Registrations and listings are mandatory.
Labels – Cosmetic labels need to comply with cosmetic labeling regulations while OTC Drug labels require compliance to OTC drug labeling regulations and combination drugs requires compliance to regulations specific to combination product labeling.
NDC number: Drug products are required to have a labeller code while cosmetics are exempt from the requirement

Liberty Management Group Ltd provides assistance with FDA Registration for Drugs and Cosmetic Establishments, Label compliance, US Agent service and many more FDA regulations.

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FDA Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on: July 31, 2019

Who regulates cosmetics for animals?

The Federal law defines cosmetics as articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and articles intended for use as a component of any such articles.

The Act specifically addresses cosmetics used on human body.

So, what about the cosmetics used on animals?

Cosmetics used on animals are commonly referred to as grooming aids. Animal soaps, shampoos and other products that are intended for cleansing or promoting attractiveness of animals are not regulated by FDA. So, the FDA requirements that apply to human cosmetics do not apply to animal grooming aids.

However, if such products are intended for any therapeutic purpose or if they are intended to affect the structure or function of the animal, they are subject to FDA regulations as new animal drugs. Such products can be introduced into US markets after FDA’s approval and compliance to all the FDA regulations regarding animal drug products.

Liberty Management Group Ltd. can help you classify your animal products into FDA regulated vs not FDA regulated category and help you with FDA regulations if required.

Namrata

FDA Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on: July 17, 2019

Color Additives in Cosmetics

FDA regulates cosmetic products and its ingredients. Color additives are added to cosmetic products to improve their appearance. Color additives are subject to strict system of approval under the FD&C Act. Failure to meet US color additive requirements may cause a cosmetic to be adulterated and make it subject to detention at the port of entry.

The FDA requirements for color additives that are added to cosmetics are as follows:

All Color additives must be approved by FDA. There must be a regulation specifically addressing a substance use as a color additive, specifications and restrictions.
Along with approval, many color additives are also required to be batch certified by FDA if they are to be used in cosmetics marketed in the US. This means that FDA chemists have analyzed a sample from the batch and have found that it meets the requirements for composition and purity stated in the regulation—called a “listing regulation”—for that color additive. FDA determines the need for batch certification based on whether the color additive needs this level of control to protect the public health. Some color additives, in their uncertified forms, might contain impurities at levels that pose a health concern.
Color additives may only be used as stated in the regulations pertaining them including maximum permissible concentration in the finished product.

FD&C Act categorizes color additives into two main types:

Those subject to certification – Petroleum based color additives aka coal tar dyes or synthetic organic colors. Such colors usually have 3-part names e.g.; FD&C Yellow No. 5
Those exempt from certification – Obtained primarily from mineral, plant or animal sources.

A list of color additives approved for use in cosmetics can be found here https://www.fda.gov/industry/color-additives-cosmetics/color-additives-listed-use-cosmetics-code-federal-regulations

Some color additives are approved for use for one use and excluded for use in another.

To ensure that the cosmetic products do not contain any unapproved color additive or other unapproved ingredients, a manufacturer can avail LMG’s label and ingredient review service.

Namrata

FDA Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on: July 03, 2019

Food Date Labeling

All packaged foods are required to bear labeling as per FDA regulations. There are mandatory elements of labels which must be present. Some elements of labels are not made mandatory by FDA, but some labelers may choose to adopt them.

Under the Federal Law, manufacturers of packaged foods are not required to place quality-based date labels on their products except for infant formula. Manufacturers may choose to voluntary put date labels on their product but as there are no uniform descriptions used on food labels for dating in USA, a wide variety of phrases are used for product dating such as “Use before”, “Sell By”, “Expires on”, “Best By” etc. to describe the dates to indicate when a food may be at its best quality. On survey in 2007, FDA found that most consumers are not able to distinguish between different date labeling phrases.

According to USDA, in USA, 30 percent of food is lost or wasted at retail or consumer level. This implies that about $161 billion worth of food is thrown away every year in USA. US FDA believes that food wastage is due to consumers fears about food safety and their misunderstanding of the meaning of terms on packaged food labels.

FDA has recently issued an advisory letter to the food industry supporting standardizing of voluntary date labeling if the date is simply used for quality not safety. Such standardization can provide consumers with information that is easy to understand.

FDA strongly supports manufacturers use of phrase “Best if used by” when they choose to apply a quality date label. This makes consumer understand that the date label is about quality of product not its safety and thus do not have to be discarded after the date if stored adequately. If the products have changed noticeably in color, smell or texture, consumers may avoid eating them.

To ensure your product labels are FDA compliant, you can use LMG’s label review service. Our experienced label team goes over each element of label with you in detail resulting in a fully compliant label.

Namrata

FDA Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on: June 19, 2019

Who needs to register with FDA?

Owners, operators or agent in-charge of domestic as well as foreign facilities that are engaged in manufacturing, processing, packing or holding for human or animal foods for consumption in USA are required to register with FDA unless exempt from the requirement to register under 21 CFR 1.226.

Facilities that are exempt are:

Farms
Restaurants
Retail Food Establishments e.g. grocery stores
Nonprofit Food Establishments
Fishing Vessels
Facilities that manufacture/process, pack, or hold food entering US solely for the purpose of exportation or trans-shipment to another country
Private residence of individuals
Post Offices, Freight Forwarders

While registering a facility with FDA, the owner, operator or agent in-charge is required to provide accurate Facility info including the names of Emergency contact, Products, Trade names under which it conducts business and US Agent for the purpose of FDA communications. Also, owner, operator, or agent in charge provides an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act.

If a facility is required to register with FDA, they must register before beginning manufacturing, processing, packing, or holding operations in USA.

In addition to registration, all registered facilities are also required to renew FDA registration between Oct -Dec every even numbered year. FDA will consider a registration for a food facility to be expired if the registration is not renewed as required. Such registration will be cancelled and removed by FDA from its system.

Staring Oct 2020, FDA will mandate submission of UFI (Unique Facility Identifier) for all food facilities. This UFI will be required for all new registrations as well as registration renewals. FDA will not confirm your registration or provide you with a registration number until FDA verifies the accuracy of your facility’s UFI and verifies that the facility-specific address associated with the UFI is the same address associated with your registration.

Liberty Management Group Ltd provides assistance with FDA Registration, Biennial Renewals, US Agent service and many other FDA regulations.

Namrata

FDA Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on: June 06, 2019

Dietary Supplement Advisory List

To market dietary supplements in US, manufacturers need to be FDA registered and ensure that their product ingredients are safe and approved by FDA.

In public interest, the FDA has unveiled an online tool, Dietary Supplement Ingredient Advisory List, that alerts the public when FDA identifies any ingredients that do not appear to be lawful ingredients in dietary supplements.

The new list can be used by consumers who do not wish to purchase any dietary supplements that contain questionable ingredients as well as manufacturers or distributors who wish to avoid selling supplements with such ingredients in their products.

Inclusion on the Dietary Supplement Ingredient Advisory List does not mean that FDA has determined the ingredient to be unsafe. Ingredients are added to this list on the basis of preliminary assessment enabling FDA to communicate to public while it completes a final determination regarding such ingredients. The reasons based on which an ingredient may be added to the list are:

The ingredients appear to be excluded from use in a dietary supplement
The ingredient does not appear to be a dietary ingredient, or does not appear to be an approved food additive or GRAS for use, or
The ingredient appears to be subject to the requirement for pre-market notification, but the requirement has not been met

The list is not exhaustive, and ingredients may be added to or removed from the list as and when FDA deems fit.

This new list is a step in the FDA’s ongoing effort to strengthen and regulate the dietary supplement market and better protect consumers from unsafe products.

To ensure that the ingredients that the manufacturers are adding to their products or planning to add to their products are safe and not questionable, an ingredient and label review service of LMG can be availed.

Liberty Management Group Ltd has been serving clients across the world with FDA registrations, label and ingredient compliance and many more FDA regulations. Our technical experts have in-depth knowledge of FDA regulations and guide you every step of the way regarding all FDA regulations.

Namrata

FDA Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on: May 22, 2019

Food Labels

In order to market food products in USA, the manufacturers and distributors must be registered with FDA and their product labels must be FDA compliant.

FDA is responsible for assuring that foods sold in the United States are safe, wholesome and properly labeled. This applies to foods produced domestically, as well as foods from foreign countries.

FDA does not pre-approve product labels, so it is the responsibility of the food manufacturers to ensure compliance. To facilitate that, FDA has detailed comprehensive food labeling regulations. These regulations provide details on each required component of the product label such as Product Name, Type, Quantity, Manufacturers info, Serving size, Nutrition facts, Foreign language etc. The minutest details such as text type, font size, placement is detailed in the guidelines.

In 2016, FDA introduced a new Nutrition Facts Table for all packaged foods with an aim to provide the consumers with more information about the foods they eat and then make an informed decision about consuming them.

The new changes highlight the calorie and servings information along with declaration of the percentage daily values of essential nutrients. The new requirements also modified the footnote to Nutrition Facts Table explaining the meanings and importance of % Daily Values. Some nutrients have been made mandatory while others are made optional.

The new requirement also changes the serving size to what people are actually eating than what they should be eating.

Both foods manufactured as well as imported into US are required to abide by the FDA’s labelling regulations.

FDA has provided the following dates regarding compliance with above nutrition label changes:

January 1, 2020 – For manufacturers with USD 10 million or more in annual food sales

January 1, 2021 – For manufacturers with less than USD 10 million in annual food sales

Since manufacturers still have time to begin using the new and improved Nutrition Facts label, we can still see both label versions on the products in market. However, soon the adoption of new label will be mandatory for all.

The list of labeling requirements is long, and it becomes rather confusing and tiring to go through each one of them and ensure compliance. To ensure a 100% compliance, manufacturers and labelers can use LMG’s label review service. It is fast, effective and economical.

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

Namrata

FDA Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on May 08, 2019