California’s Sherman Food, Drug, and Cosmetic Law is the state statute, codified at Health and Safety Code sections 109875 through 111929.5, that sets safety, licensing, and labeling standards for food, drugs, medical devices, and cosmetics sold in California. The California Department of Public Health (CDPH) enforces it through its Food and Drug Branch, and violations can bring criminal charges, civil penalties of up to $10,000 per day, product embargoes, and mandatory recalls. If your business makes, packs, distributes, or sells any of these products to California consumers, including from out of state or online, the law applies to you.
Who Has to Comply
The law reaches the full chain: manufacturers, processors, packers, distributors, wholesalers, and retailers. It also covers out-of-state companies whose products enter the California market, including online sellers and interstate distributors who may not realize they fall under CDPH jurisdiction. What you need to do before you start selling depends on the product.
Processed Food
Anyone who manufactures, packs, or holds processed food in California must obtain a Processed Food Registration from the CDPH Food and Drug Branch before starting operations. The registration lasts one calendar year and cannot be transferred to another business. Cottage food operations registered under a separate permit and microenterprise home kitchens are exempt.1California Legislative Information. California Code Health and Safety Code HSC 110460
Drugs and Medical Devices
No one may manufacture drugs or devices in California without a valid license from CDPH. The license lasts two calendar years and is non-transferable. CDPH can also require manufacturers, wholesalers, or importers of prescription ophthalmic devices to obtain a separate license.2Justia. California Health and Safety Code 111615-111656.13 – Licenses
Cosmetics
Cosmetics do not require pre-market approval in California, but manufacturers must comply with all adulteration and misbranding rules under the Sherman Law. Separately, the federal Modernization of Cosmetics Regulation Act of 2022 requires most cosmetic facilities to register with the FDA and renew that registration every two years, with a narrow small-business exemption that does not apply to products contacting the eye, injected products, products intended for internal use, or products altering appearance for more than 24 hours.3U.S. Food and Drug Administration. Registration and Listing of Cosmetic Product Facilities and Products
What Makes a Product Illegal to Sell
Two concepts carry most of the enforcement weight under the Sherman Law: adulteration and misbranding. Either one makes a product illegal to manufacture, hold, distribute, or sell in California.
Adulteration
The Sherman Law flatly prohibits manufacturing, selling, delivering, or holding adulterated food, drugs, or cosmetics.4California Legislative Information. California Health and Safety Code 1106205California Legislative Information. California Health and Safety Code 1106256California Legislative Information. California Health and Safety Code 111300 The definitions closely track federal law.
Food is adulterated if it contains a poisonous or harmful substance that could injure a consumer, consists of filthy or decomposed material, was prepared or held under unsanitary conditions where it could have become contaminated, or comes from a diseased animal. It is also adulterated when a valuable ingredient has been removed, a cheaper substance substituted, or damage concealed to make the product appear better than it is.7Office of the Law Revision Counsel. 21 U.S. Code 342 – Adulterated Food
A drug is adulterated if it was manufactured or held in unsanitary conditions, if its strength or purity falls below labeled specifications, or if it contains unsafe color additives. Cosmetics are adulterated if they contain harmful substances under normal use, were manufactured or held under insanitary conditions, or include prohibited or restricted ingredients.
Misbranding
A product is misbranded whenever its labeling is false or misleading in any way. That single standard runs through every product category, and it catches far more than outright lies. Omitting required information, using deceptive packaging, or burying mandatory disclosures in fine print can all qualify.
For food, labels must comply with federal nutrition labeling standards, list the common name of each ingredient in multi-ingredient products, and state the total juice percentage in beverages containing fruit or vegetable juice.8California Legislative Information. California Health and Safety Code 110660 – Misbranded Food Allergens must be declared under the federal Food Allergen Labeling and Consumer Protection Act; failure to do so is misbranding.9U.S. Food and Drug Administration. Food Allergen Labeling and Consumer Protection Act of 2004
Drug and device labels must list the established name and quantity of each active ingredient.10California Legislative Information. California Health and Safety Code 111330 – Misbranded Drugs or Devices Nonprescription drugs must also list each inactive ingredient, and certain substances including codeine, arsenic, mercury, and barbituric acid derivatives must be disclosed whether active or inactive.11California Legislative Information. California Health and Safety Code – Misbranded Drugs or Devices
Cosmetic labels must state the manufacturer’s name and address along with an accurate quantity of contents, display required information so an ordinary consumer can read it under normal purchase conditions, and meet federal tamper-resistant packaging rules.12California Legislative Information. California Health and Safety Code – Misbranded Cosmetics
How CDPH Enforces the Law
The Food and Drug Branch conducts routine and unannounced inspections, evaluating sanitation, product handling, and overall integrity. Inspectors can collect samples for laboratory testing to check for contamination, adulteration, or misbranding, and every violation gets documented in a report that determines what comes next. The department also acts on consumer complaints, whistleblower reports, and independent investigations, and coordinates regularly with local health departments and the FDA.
When problems turn up, CDPH can issue warning letters, notices of violation, or cease-and-desist orders, and can pursue voluntary or mandatory recalls for unsafe products. One tool that catches businesses off guard is the embargo. When CDPH finds a product it believes is adulterated, misbranded, or otherwise in violation, it can detain and embargo that product on the spot. Once a product is embargoed, it is illegal to remove, sell, or dispose of it without permission from CDPH or a court order.13California Legislative Information. California Health and Safety Code 111865 If the department wants the product permanently removed from the market, it can file a condemnation action in the superior court for the county where the product sits.14California Legislative Information. California Health and Safety Code 111880
Criminal Penalties
The baseline criminal penalty for violating the Sherman Law is a misdemeanor carrying up to one year in county jail, a fine of up to $1,000, or both.15California Legislative Information. California Health and Safety Code 111825 – Penalties That covers most first-time, unintentional violations. Certain conduct carries steeper consequences:
- Removing, selling, or disposing of an embargoed food, drug, device, or cosmetic without authorization is punishable by up to one year in county jail, a fine of up to $10,000, or both.
- Purchasing or selling a foreign dangerous drug, medical device, or product not approved by the FDA or obtained outside the licensed supply chain is a misdemeanor punishable by up to one year in jail, a fine of up to $10,000 per occurrence, or both.
- A violation committed after a prior conviction, with intent to defraud, or involving intentional adulteration of food or drugs becomes punishable by county jail, state prison, a fine of up to $10,000, or both. This is the provision that can elevate a Sherman Law violation to a potential felony.
Civil Penalties
CDPH can also impose civil penalties without pursuing criminal charges. The department may assess up to $1,000 per day for violations of the Sherman Law generally, with each day a violation continues counted as a separate offense. For violations that also fall under the criminal penalty provisions of Section 111825, the civil penalty rises to up to $10,000 per day.16California Legislative Information. California Health and Safety Code 111855
Civil and criminal remedies are not mutually exclusive. CDPH can pursue civil penalties against a business while prosecutors bring criminal charges against the individuals responsible. The California Attorney General and local district attorneys may also seek enhanced penalties through civil litigation when conduct is fraudulent or reckless. For ongoing violations, per-day penalties accumulate quickly, and businesses may be required to compensate affected consumers.
Records You Need to Keep
CDPH can request records during any inspection or investigation, and failing to produce adequate documentation is itself an enforcement trigger. Food manufacturers and distributors should maintain batch production logs, ingredient sourcing details, and sanitation procedures. Drug manufacturers need documentation of formulation processes, quality control measures, and distribution channels. Cosmetic companies must keep records of product formulations and any adverse consumer reactions reported to them.
Federal regulations require food safety records to be retained at the facility for at least two years after the date they were prepared.17eCFR. 21 CFR 117.315 – Requirements for Record Retention California drug manufacturing licenses run for two years, and CDPH expects supporting records to be available throughout that period and beyond. Retention requirements vary by product type, so the safest practice is to keep all compliance records for at least two years and check whether your specific product category demands longer.