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West Covina Regulatory Compliance Attorneys

We Can Help You Navigate State & Federal Regulations

Coimbra Law Firm understands the plight of entrepreneurs, start-ups, and established businesses in facing down the myriad state and federal regulations that can impact a business. Failing to comply with these regulations can result in significant profit losses and interfere with your ability to grow and sustain your business.

Fortunately, we provide legal representation and regulatory consulting to corporations, sole proprietorships, limited liability partnerships, business entities working as distributors, manufacturers, and importers, and industries that need to comply with the Food and Drug Administration (FDA). These industries include cosmetics, dietary and nutritional supplements, electronics, food and beverages, and medical devices.

The various agencies that you may have to deal with as a manufacturer, distributor, or importer in one of the above-listed industries include:

  • U.S. Food and Drug Administration (FDA)
  • U.S. Department of Agriculture (USDA)
  • Environmental Protection Agency (EPA)
  • Federal Trade Commission (FTC)
  • Consumer Product Safety Commission (CPSC)

Companies that neglect or fail to comply with statutes and regulations (or who otherwise defy these federal administrative bodies) can face civil and even criminal sanctions and liability. Contact Coimbra Law Firm at (626) 827-7222 to learn how we can help you protect your business and its corporate image.

What We Bring to the Table

Our regulatory compliance law firm can assist you with getting the proper documentation, licensing, certification, and permitting to be able to lawfully operate your products not only in California but throughout the greater United States.

The regulatory compliance attorneys at Coimbra Law Firm can represent you in the following ways:

  • Ensuring that your client marketing, advertising materials, and campaigns abide by FTC and CPSC regulations.
  • Monitoring FDA import alerts for the types of products you sell, manufacture, or distribute, as well as getting you any necessary exemptions (and removal) from these alerts.
  • Resolving FDA import detentions and refusals of your products so they can clear the import process, allowing you to lawfully distribute and sell your wares.

In addition to these vital services, our regulatory compliance lawyers can also provide you with legal advice regarding the various aspects of your business, including product manufacturing and advertising, product labelling, export certification, and safety screenings.

Our attorneys also deal with conflict resolution regarding matters like administrative quarantine, product refusal at ports of entry, recall letters, and warning requests. Our goal is to provide you with the ability to clear any and all regulatory hurdles in order to protect your business and your bottom line.

How Non-Compliance Can Kill Your Business

Under California regulatory schemes, any product that does not comply with state and federal laws will get the “kiss of death;” that is, classification as “adulterated,” “mislabeled,” and/or “unsafe for human consumption.” These products will be denied entry into the country and placed under quarantine and administrative holds. In this scenario, your products will likely be returned to the manufacturer or destroyed, leading to costly losses for your business.

Food & Beverages

Food and beverage items produced or imported into the U.S. are subject to FDA regulations, while raw food and beverage items – such as meat, eggs, dairy, vegetable, and fruit produce – are regulated by the U.S. Department of Agriculture. Imported food and beverages must be subjected to FDA Food and Facility Registration before they can be approved for human or animal consumption. All food establishments that manufacture, pack, store, or distribute food in the United States are subject to Food Facility Registration.

Our law firm can help clients ensure that all manufactured or imported food and beverages, local or otherwise, are compliant with the current state and federal regulations covering production, processing, handling, storage, and transport.

Dietary Supplements

Dietary supplements are legally considered food items under the Federal Food, Drug, and Cosmetic Act. As such, they are subject to the same regulations that cover food and beverages in terms of safety, packaging, and labeling requirements. Dietary supplements are recognized as articles that are ingested in a similar manner to food items, for the purpose of delivering nutrients and other substances that may not be present in the average American diet. The use of supplements can improve a person’s wellbeing and ensure their general health.

Our law firm can help clients ensure that manufactured or imported drug supplements are compliant with all regulatory statutes including, but not limited to: safety requirements, product claims, label compliance, good manufacturing practices (GMP), and other required regulations as mandated by the USDA.

Pharmaceuticals

Medicinal drugs and other pharmaceutical products are subject to complex FDA regulations, such as the New Drug Application process for new drugs, as well as labeling and product claims regulations. As per the FDCA and FDA definitions, pharmaceuticals are “products intended for use in the diagnosis, cure, treatment, or prevention of disease.”

The lawyers at Coimbra Law Firm can help ensure that all pharmaceutical products marketed by your company comply with relevant regulatory statutes, particularly in documentation regarding acceptable ingredients, dosage information, and labeling requirements.

Cosmetics

The FDA defines cosmetics as products that are “intended to be rubbed, poured, sprinkled, or sprayed onto the human body for cosmetic purposes.” There are strict regulations governing cosmetic products, specifically in the labeling, purity, safety, product quality, and transparency of ingredients. According to the California Safe Cosmetics Program, there are approximately 900 chemical ingredients that are considered safe for human use. A company must disclose a product’s ingredients to the state and health departments for approval before marketing it to consumers.

A company does not need FDA approval to sell cosmetic products in the United States. That said, there are steps you must take to avoid costly product liability issues. Our regulatory compliance attorneys can make sure your products comply with all existing and relevant regulations, thereby protecting you from facing expensive and damaging lawsuits in the future.

Medical Devices & Electronic Products

Countless entrepreneurs and startups in Silicon Valley are combining electronic products with medical devices to produce novel consumer goods that function as personal health monitoring tools. Popular products like the Apple Watch and Fit Bit are facing intense FDA scrutiny, as they technically fall under two categories: medical devices and electronic products.

The regulation process for personal health monitoring tools is both complex and dynamic. You need to stay on top of these regulations to protect your business. Our law firm can help you navigate these regulations to ensure that your company is always fully compliant.

Contact Coimbra Law Firm Today

The key to any successful business in California is strict compliance with state and federal regulatory statutes. The highly-experienced West Covina regulatory compliance attorneys at Coimbra Law Firm can help ensure that your company fully complies with all required compliance statutes. We take great care in providing business owners with personalized attention, complete discretion, and a team of lawyers working to deliver the best legal assistance available.

Contact Coimbra Law Firmat (626) 827-7222 if you’re ready to protect your business and corporate image.

Get in Touch with Coimbra Law

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