California Regulatory Compliance Attorney
Mohajerian provides regulatory consulting services to manufacturers, distributors, and importers of foods, beverages, dietary supplements, drugs, cosmetics, medical devices, or electronic products. Our FDA lawyers assists foreign manufacturers and U.S. importers with obtaining required documentation, certifications and licenses. In addition, product labels and marketing literatures are regularly reviewed for proper claims and compliance issues. Manufacturers and importers of foods, dietary supplements, cosmetics, drugs, devices, or tobacco require legal advice on regulatory statutes involving the Food and Drug Administration (FDA), the Environmental Protection Agency (EPA), the U.S. Department of Agriculture (USDA), the Federal Trade Commission (FTC) and the Consumer Product Safety Commission (CPSC). We also advise on compliance with state regulations such as California mandates regarding identification of ingredients defined as being potentially toxic. Our FDA lawyers assist out clients with:
- resolving FDA import detentions and FDA import refusals;
- monitoring FDA import alerts and obtaining removal or exemption from them; and
- ensuring that their advertising and marketing materials comply with FDA and FTC regulations.
The firm provides advice on California Department of Public Health actions, Safe Cosmetics Program compliance, Proposition 65 compliance and enforcement issues as well as Pre-Market Notifications, product labeling, and export certification for foods. Mohajerian advises clients on dietary supplements, cosmetics, drugs and medical devices. The firm deals with resolving administrative holds, detentions, refusals of articles at the ports, form 483 related to inspections, recall requests and warning letters. Non-compliant foods, cosmetics, drugs or medical devices will ordinarily be treated as “misbranded” or “adulterated”, and therefore illegal. Refusal of entry could ultimately put a shipment in danger of being destroyed, making a strong defense and clear preventative procedures crucial to import and export businesses. With the risks that these potential consequences pose to your businesses, Mohajerian gives the personalized attention needed to make sure businesses comply with all relevant regulations.
Medications are also subject to complex FDA regulations, whether prescription drugs or over the counter (OTC). New prescription drugs are subject to the New Drug Application process, including reporting experimental results. OTC products sold by nonpharmacists can be developed through the use of FDA monographs. These references document acceptable ingredients, dosages and labeling that can be used and marketed without additional FDA approval.
Generally Class 1 medical devices require only that the manufacturer be registered with FDA under the FDA Medical Device Establishment Registration regulations, and that the registered establishment submit a medical device listing to FDA identifying the product being distributed in the U.S. Generally Class 2 medical devices are subject to Pre-Market Notification (PMN) aka FDA 510(k) submission. Generally Class 3 medical devices are subject to the FDA Pre-Market Approval (PMA) process.
Radiation Emitting Products
The FDA regulates radiation emitting electronic products. The Radiation Control for Health and Safety Act applies to these products. Sometimes radiation emitting electronic products are also medical devices. In such event, the product must comply with both the Radiation Control for Health and Safety Act and FDCA. The FDA also includes a Center for Devices and Radiological Health to oversee firms that either manufacture or import these types of devices.
USDA – FSIS
The FDA regulates foods and beverages distributed in U.S. and U.S. Department of Agriculture (USDA) regulates meats (beef, lamb, pork), poultry and eggs. Not all foods require FDA approval but all food establishments that manufacture, pack and store food are subject to Food Facility Registration. FDA Food Facility Registration must occur before the imported foods arrive in the U.S. for human or animal consumption.
Dietary supplements are foods, as that term is defined by the Federal Food Drug and Cosmetic Act (FDCA). The FDA regulates the food category of dietary supplements, which are articles that are ingested (like foods) for the purpose of providing nutrients or other substances that may not be present in the diet in sufficient quantities, promoting general health and well being. The Dietary Supplement Health and Education Act of 1994 (DSHEA) provides FDA jurisdiction. Because dietary supplements are foods, dietary supplement manufacturers, packers and storage facilities are subject to FDA Food Facility Registration regulations. Liquid supplements that are low acid canned foods are subject to Food Canning Establishment (FCE) and Scheduled Process Identification (SID) filing regulations. Primary issues facing manufacturers and distributors include safety, label compliance, product claims, filing notifications to FDA, good manufacturing practices (GMP) regulations, and complying with USDA.
Alcoholic beverage import and distribution are regulated by the Bureau of Alcohol Tobacco and Firearms (BATF). The Alcohol and Tobacco Tax and Trade Bureau (TTB) issues permits for businesses to operate and sell alcoholic beverages. TTB regulates the labels that appear on all alcoholic beverages. Tobacco manufacturers and importers must provide tobacco health documents created post June 22, 2009, to the FDA.
Extending Authorities to All Tobacco Products, Including E-Cigarettes, Cigars, and Hookah
The FDA has extended its authority to cover all products that meet the definition of a tobacco product.
Previously, the FDA regulated cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco, but in 2016, the FDA finalized a rule which extends the FDA’s authority to include the regulation of electronic nicotine delivery systems (such as e-cigarettes and vape pens), all cigars, hookah (waterpipe) tobacco, pipe tobacco and nicotine gels, among others.
The FDA will:
- Review new tobacco products not yet on the market;
- Review claims by tobacco product manufacturers;
- Evaluate the ingredients of tobacco products and how they are made; and
- Communicate the potential risks of tobacco products.
Cosmetics are products intended to be rubbed, poured, sprinkled, or sprayed on to the human body for cosmetic purposes. FDA cosmetic regulations cover labeling, product quality, purity and safety, permitted ingredients, and application. FDCA and FDA regulations define the term drug, in part, by reference to its intended use, as “products intended for use in the diagnosis, cure, treatment, or prevention of disease”. The term medical device under the FDCA refers to instruments, machines, implants including component parts or accessories which are intended for use in the diagnosis of disease or intended to affect the structure or function of a person or animal. Although the FDA regulations covering cosmetic products do not require pre-approval, it is still important to be aware of ingredient, labeling, and advertising guidelines. The California Safe Cosmetics Program maintains a list of approximately 900 chemical ingredients that must be disclosed to the state health department. Mohajerian attorneys can help clarify definitions and requirements to make sure that your products meet standards and are properly disclosed and advertised.
This final rule goes into effect on August 8, 2016.