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Is your facility meeting these requirements? Find out now and how to get help becoming certain that your supplements are meeting Current Good Manufacturing Practices (CGMP’s) and FDA regulations.

Is Your Manufacturing Facility up To Snuff?

Under DSHEA, you have the responsibility to create and maintain a manufacturing facility that protects the ingredients from becoming adulterated. Adulteration can happen during the manufacturing process, the packaging process, and the labeling process. Therefore, it’s crucial to be certain that your facility is set up in a manner to facilitate the safety and efficacy of your products.

Are You Keeping Appropriate Records?

CGMP’s also regulate how a dietary supplement manufacturing facility must keep records. In order to maintain FDA compliance, your facility must:

• Create and utilize master records for batch production and manufacturing
• Create written procedures for quality control
• Maintain written records of each product complaint that is relative to CGMP’s
• Retain all records for products for one year or more past the shelf life of the product. If shelf life is not applicable, two years or more beyond the date of distribution of that product

Records can be challenging to keep, especially ones as detailed as those listed above. It’s best to consult with an experienced FDA lawyer. An FDA lawyer can help you learn record keeping practices that ensure your compliance with the FDA.

Do You Have the Right Employees and Equipment?

DSHEA also regulates a dietary supplement manufacturing facility’s hiring practices and equipment. Under DSHEA, your facility has the responsibility to hire only employees and supervisors who are qualified to be working in the dietary supplement industry. More specifically, these people must be qualified to work with the supplements your individual facility manufactures.

Additionally, DSHEA requires that all utensils and equipment used to manufacture a dietary supplement are designed appropriately and are of a quality that is in accordance with their intended use. This means you may need to purchase specialized equipment depending on what type of dietary supplement your facility manufactures.

At FDAlaw.net, we can help you navigate the challenges that both DSHEA and CGMP’s present to dietary supplement manufacturers. Contact us today for a consultation.

The prior deadline for companies with over 500 full time equivalent employees was May 31, 2017.

The FSVP is a program that importers covered by the rule must have in place to verify that their foreign suppliers are producing food in a manner that provides the same level of public health protection as the preventive controls or produce safety regulations, as appropriate, and to ensure that the supplier’s food is not adulterated and is not misbranded with respect to allergen labeling.

At Capote Law Firm, we can guide your company and help implement the program to ensure compliance with the FSVP rule. Our FSVP program is tailored to your company. We create, implement, manage and/or train someone to manage as per your company’s unique requirements.

Importers are required to (1) identify and evaluate hazards in the foods they import; (2) evaluate supplier’s performance and the risk presented by the food; (3) conduct supplier verification activities; (4) perform corrective actions; (5) re-evaluate and reassess the FSVP program periodically; and (6) document everything.

Remember the deadline of March 2018 your company must have a fully implemented foreign supplier verification program. These programs take approximately 6 months to fully implement, depending on the amount of suppliers and food products covered.

There are additional deadlines and Capote Law Firm can provide you an analysis on your company’s specific deadlines to ensure compliance.

We can provide you flat fee pricing on this program, taking the guess work out of your budget.

Don’t Delay! Contact us today for a consultation by calling.

Here’s how to maintain compliance when making cosmetics.

The Key: Ensure Your Product Does Not Become Adulterated

According to FDA regulations, cosmetics may be manufactured at home, at a salon, or small facility. This is allowed as long as the environment does not cause the product to become adulterated. This means that the environment in which you manufacture your cosmetics must not cause them to become contaminated or potentially harmful when used as directed.

Cosmetic Compliance Checklist

Look at each area of your cosmetic manufacturing to be certain that nothing is causing your product to become adulterated.

Contamination. The FDA does not require a sterile environment for cosmetics manufacturing. However, you still need to be aware of contamination. Contamination includes bacteria, microbes, or other substances. You must do all that you can to prevent it by maintaining a clean working environment.
Restricted Colors and Additives. Certain color additives and other compounds are banned by the FDA. These components cannot be used in any cosmetic product, regardless of its intended use. Any banned color additives or compounds can cause your product to become adulterated and is in violation of FDA regulations.

Unsafe When Used as Directed. Your cosmetics must not harm to a person when the product is used according to package directions in a safe and reasonable manner.
Examine each aspect of your cosmetic thoroughly. Be certain that the ingredients and packaging do not cause the product to become adulterated. If you are inspected by the FDA, you could receive a cease and desist if your cosmetics become adulterated.

When to Get Legal Help

Navigating FDA regulations, even the simpler ones having to do with cosmetics, can be challenging. If you’re manufacturing cosmetics in a small facility, a salon, or at home, maintain compliance with FDA laws and guidelines.

An experienced FDA lawyer can help you learn more about the regulations you need to meet. Contact us today for a consultation to discuss your cosmetics venture and how to best maintain compliance with Food and Drug Administration guidelines. Call now for a consultation.

The Wm. Reece Smith, Jr. Leadership Academy is a multi-session training program designed to assist a diverse and inclusive group of lawyers in becoming better leaders within our profession, in their chosen path, while enhancing their leadership skills. Each year a select group of participants are selected from applications submitted to The Florida Bar to become Academy Fellows.

During their one-year term, Academy Fellows follow a curriculum tailored to enhance their professional development, knowledge base and experience, including attending The Florida Bar events and special educational programs. Academy Fellows are given the opportunity to learn more about the inner workings of the Bar and their role in the legal profession, while enhancing their personal leadership skills. The Academy’s Mission is to identify, nurture and inspire effective leadership within the Bar and the legal community.

Ms. Capote’s three-year term will begin on July 2017. For more information on the Florida Bar Leadership Academy visit https://www.floridabar.org/about/academy/

There are three major classifications for medical devices under FDA law. It’s crucial to understand why you need to classify your medical device.

What Requirements Should You Be Meeting While Designing or Manufacturing Your Device?

Learning about medical device classification before you design or manufacture your device can help the FDA approval process go smoothly. You can eliminate bumps in the road by anticipating what you’ll need. Therefore, have it ready as you design and manufacture your device.

What Requirements Should You Be Meeting Before Submitting Your Device?

One imperative part of classifying your device is to know what requirements you need to be meeting before you submit your device to the FDA. Some classifications of devices don’t have as many requirements that must be met pre-market, while others have a great deal. You should be a step ahead of the game when it comes to knowing what you need to do before you can sell your medical device.

Know how Much It Will Cost to Get Your Device to Market

Another helpful benefit of understanding FDA classification for medical devices is that it can help you better estimate how much it’s going to cost to design, manufacture, advertise, and sell your product. For most people, this is a crucial piece of information that will help them determine whether or not they can actually bring their medical device to market.

How to Get Help With Medical Device FDA Regulations

FDA regulations surrounding medical devices are confusing at best. It’s always a good idea to consult with an experienced professional who knows FDA law from front to back and can give you the guidance you need to move through the various stages of designing and marketing a medical device.

Contact the Capote Law Firm today for a consultation to discuss the details about your medical device. Whether you’re just beginning to have an idea of a medical device you can sell, you’re in the middle of manufacturing your device, or you’ve made your device and need to submit it to the FDA, we can help.

Call us now. We are available now to give you the information you need to make informed decisions going forward.

This is a clear violation of the Federal Food, Drug, and Cosmetic Act (FDCA). Here’s what you need to know about what you should — and shouldn’t — be putting on your product labels.

What Needs to Be on Your Product Label

The product label, in addition to your logo and marketing content, should have a Primary Display Panel. The Primary Display Panel should have:

• Statement of Identity — this is simply a statement of what the item is. It generally uses the most commonly recognized names for an item.
• Statement of Net Quantity — your PDP should state the net quantity of your product contained within the packaging. Depending on what your supplement is, you can display net quantity in weight, measure, or both.
• Ingredients List — this is perhaps the most crucial component of your Primary Display Panel. Your ingredients should be listed prominently on the package. Arrange them in order of greatest amount used within the product to least amount used.
• Nutrition Information — your label should contain any nutrition information that is applicable to your product. This labeling requirement is very similar to food labeling requirements, since dietary supplements are typically ingested.
• Contact Information — the FDA requires that the product manufacturer or distributor’s name, address, and other contact information is displayed prominently on the label.

What Not to Include on Your Product Label

While there are some things that you absolutely want to be sure is on your product label, there are a few things that you want to leave out. Namely, any claims or guarantees that the product will do a certain thing. For example, if you are manufacturing a weight loss supplement, you do not want to guarantee weight loss on your packaging. Also, if you are selling an essential oil, you don’t want to make any claims that the oils treat or cure diseases or illnesses.

When to Contact an Attorney

It’s always in your best interest as the manufacturer of a product that is regulated by the FDA in some way to have the label examined by an experienced attorney. At FDAlaw.net, we can help you ensure that your label meets FDA requirements and leaves out anything that could potentially cause you to be sent a warning letter. Contact us today for a consultation by calling.

Cosmetics Are Not “Approved” by The FDA, and The Spirit of The Law Matters

The FDA does not have to approve cosmetics in the same way that they do prescriptions or even medical devices. For example, cosmetic manufacturers can use almost any raw ingredient, with a few exceptions, in their cosmetics under one condition. That condition is the ingredients cannot be harmful to a person when used in the manner they are intended. For example, an ingredient in mascara may not be harmful when used near the eyes, but may cause illness if ingested. This is allowed with proper warning labels.

List of Prohibited Ingredients

Although cosmetic manufacturers have a lot of leeway in what they can use in their cosmetics, there are some ingredients that are definitively prohibited from use, including:

• Chloroform
• Hexachloraphene
• Mercury compounds or ingredients containing mercury
• Bithional
• Chloroflurocarbon propellants
• Methylene chloride
• Vinyl chloride
• Sunscreens, if not used to protect product color and with proper labeling
• Complexes containing zirconium

Cosmetics As Drugs

Some cosmetics may be subject to regulation by the FDA as a drug. If, for example, the cosmetic contains a sunscreen designed to protect the skin, the product would be subject to the same regulations as a drug. This also applies to many “acne free” cosmetics or cosmetics that contain chemicals to reduce or eliminate acne, such as salicylic acid and benzylkonium chloride.

Contact Us for Help Getting and Keeping Your Cosmetic Product on The Shelves
FDA laws and regulations are often difficult to understand and navigate, especially in the cosmetics industry. At FDAlaw.net, we can help you obtain the information you need to ensure that your cosmetic product meets the appropriate regulations for a product of its class. You’ll want to be sure that you don’t include any of the above listed ingredients in your cosmetic, but if you’re unsure of whether or not an ingredient is or isn’t approved for use by the FDA, we can assist you.

Contact us today for more information or to schedule a consultation to discuss your needs in detail. Call now.

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Class I

Many Class I medical devices aren’t what a lot of people would consider medical devices. A motor-less toothbrush or a callus remover could be considered a Class I device. These devices are subject to the least strict FDA controls. General controls require a mandatory recall if the device is found to be defective, among other controls.

Class II

Examples of class II medical devices might be a motorized wheelchair or an over the counter blood pressure monitor. Class II devices are subject to special controls, as well as all general controls. Special controls would require certain guidelines and performance standards, as well as special labeling requirements on how to use the product safely and effectively.

Class III

A Class III medical device is the highest class device and applies to devices like medical implants. Class III medical devices are subject to general controls and must have premarket approval by the FDA before market placement and use by hospitals or doctors. This class is the most involved and requires a great deal of work back and forth with the FDA.

When to Contact an FDA Medical Device Lawyer

Any time you are manufacturing a medical device, it’s important to consult with a lawyer regarding classification and registration. Therefore, to ensure your device is approved for market, make sure you have everything in order for the FDA.

Many companies and entrepreneurs are intimidated by the requirements of the FDA, whether they face general controls, general controls and special controls, or general controls and premarket approval. At the Capote Law Firm, we can help you navigate the challenges set forth by the FDA. Ultimately, this can help you get your medical device on the market, so you can grow your business.

Call today for a consultation to discuss your legal options.

The FDA is planning to update the regulations regarding nutrient content and health claims to conform to the updated nutrition labeling regulations published in May, 2016.

FDA’s Guidance announces that it intends to exercise enforcement discretion for products labeled as “healthy” that are not low in total fat, if the fat predominantly consists of unsaturated fats, and if the nutrition facts box declares the amounts of the poly and mono unsaturated fats. In addition, FDA intends to exercise enforcement discretion when the food contains less than ten percent of the Daily Value (DV) per reference amount customarily consumed (RACC) of vitamin A, vitamin C, calcium, iron, protein, and fiber, but the food contains at least 10% of the DV per RACC of vitamin D or potassium. For labels that do not use the updated nutrition facts panel, the manufacturer may use the old DVs. If a manufacturer uses the updated nutrition facts panel, the updated DVs for potassium and vitamin D must be used. In addition, the relevant nutrient(s) must be declared in the nutrition facts box. FDA stated, “it that it may take some time, but we want to get it right”

Currently the update of the labels is voluntary, this until 26 July 2018 or 26 July 2019 for companies with sales under $10 million. Further the FDA plans to issue new regulations in regards to the annual sales of food.

The quality of the graphics is much better (See 21 C.F.R. §§ 101.9 and 101.36), also the FDA includes a scale model of the Nutritional Information where it represents the format, the thickness of the lines, font and the main specifications which were previously contained in appendix B of 21 C.F.R. Part 101.
The FDA has responded questions however replied that additional guides for more specifics will be later developed.