FDA noted that there are no legally marketed over-the-counter (OTC) drugs that prevent nor cure the flu. However, there are legal OTC products that can reduce fever, relieve muscle aches, congestion, and other symptoms associated with the flu. FDA warns that dietary supplements labeled with flu treatments claims would be regulated as drugs by the Agency as products that are intended to treat, prevent, or cure diseases/conditions are deemed drugs under federal law. Accordingly, marketers of products with these claims should be very careful as they may be in violation of FDA laws and regulations.

In sum, when developing a product, it is important to ensure that all claims made in labeling comply with federal law and regulations enforced by the FDA. If you have any questions about how you can market products in compliance with the laws and regulations enforced by the FDA, please contact us at contact@sglawfl.com.

FDA has recently noted that many cosmetic companies have crossed the line with claims on their advertising or packaging, causing products that would otherwise be regulated as cosmetics to be considered drugs by the Agency. Recently, the U.S. Food and Drug Administration (FDA) has been issuing warning letters to companies whose claims have gone beyond promoting the cosmetic benefits of their product and into the territory of promising outcomes typically associated with drugs, such as indicating that the product is intended to treat or prevent disease, or change the body’s structure or functions. If a company fails to comply with these rules, the FDA may take additional action beyond issuing a warning letter, which could include removal of a product from the market or other sanctions, which would likely prove costly.

Warning letters that have been issued to cosmetics manufacturers for marketing products with claims that indicate that the product is a drug can be found here. The products range from skin care creams and lotions, hair care products, and even eyelash and eyebrow treatments.

In general, the FDA advises that, first, products intended to cleanse or beautify are generally regulated as cosmetics. Second, products intended to treat or prevent disease, or affect the structure or function of the body, are drugs. Third, that some products are both cosmetics and drugs. Examples include anti-dandruff shampoos and antiperspirant-deodorants, as well as makeup with SPF (sun protection factor) numbers. These products must meet the requirements for both cosmetics and drugs, as applicable.

When promoting products in the cosmetics industry, it may be advantageous to sell the potential user on the benefits that they may experience. However, it is extremely difficult for any company to toe the line between cosmetic and drug claims. For this reason, it may be particularly helpful to have a trained professional examine the claims made regarding the product to ensure their compliance with all federal laws and FDA regulations.

We offer assistance to companies with label reviews and ensuring that products comply with FDA regulations. If you would like assistance with your cosmetics products, please contact us at contact@sglawfl.com.

As we previously reported, on May 16, 2014, representatives from the U.S. Marshals Service had seized more than $11 million worth of unapproved drugs held by Masters Pharmaceuticals of Ohio and marketed by Ascend Laboratories of New Jersey. The U.S. Marshals seized urea cream 39%, hydrocortisone acetate suppositories 25 mg, urea cream 40%, pramoxine-HC otic drops, and urea lotion 40%. The FDA and U.S. Attorney for the Southern District of Ohio requested the seizure because the drugs were not marketed in accordance with FDA regulations, in that they were marketed for conditions that caused them to be deemed drugs but the Company had not secured the necessary FDA approval for the products.

The pramoxine-HC drops were intended to control itching and treat external ear infections caused by bacteria. Ascend Laboratories allegedly marketed the hydrocortisone acetate suppositories for the relief of symptoms caused by ulcerative colitis, inflamed hemorrhoids, and other inflammatory conditions. All three urea-containing products were intended to treat dermatitis, eczema, and other conditions that cause thickening of the skin.

Because none of these products have been proven safe or effective for their intended uses, i.e., obtained FDA approval for the treatment of these diseases and/or conditions, the FDA filed a Complaint alleging that the drugs were misbranded under the Federal Food, Drug, and Cosmetic Act. The complaint came approximately six months after an inspection revealed Ascend Laboratories was allegedly marketing certain products for the treatment of diseases and/or conditions without obtaining FDA approval.

The FDA’s announcement of this seizure explains that these drugs were seized under the Marketed Unapproved Drugs Compliance Policy Guide, which states that any unapproved new drug first marketed after September 19, 2011 is subject to immediate enforcement action even if the marketer never received a prior warning from the FDA. The FDA Compliance Policy Guide for unapproved marketed drugs lists several enforcement priorities. The first two priorities are drugs with potential safety risks and drugs that lack evidence of effectiveness. The FDA is also taking enforcement action against the marketers of so-called health fraud drugs. These products are represented as effective for diagnosing, preventing, curing, or treating diseases, but they have not been scientifically proven safe or effective for their intended purposes.

Drug manufacturers and marketers are subject to close scrutiny under the FDA’s guidelines. The agency has the right to seize drugs and other medical products without any prior warning, putting businesses in this industry at risk for serious losses. If you have any questions about FDA approval or you need help responding to a complaint filed by the FDA, contact us at contact@sglawfl.com.

The unapproved products that were subject to the complaint against Laclede include: Luvena Prebiotic Vaginal Moisturizer and Lubricant; Luvena Prebiotic Enhanced Personal Lubricant; Luvena Prebiotic Feminine Wipes; and Luvena Prebiotic Daily Therapeutic Wash. Two separate inspections conducted at the company’s Rancho Domingo facility, dated June 19 and June 27, 2012, found that the products listed did not have proper identification and strength listings for the active ingredients of those products, in violation of Title 21, Code of Federal Regulations, Parts 211 [21 CFR §211.165(a)] of the Act. Subsequent to the inspections the FDA sent a warning letter, dated February 14, 2013, which informed the Company that they both failed to take corrective actions regarding their testing procedures, and that based on the current labeling and marketing of the products, the FDA found the products to be classified as “unapproved and misbranded” drugs.

Based on the claims made by the Company on its product labels, inserts and website, the products were found to be in violation of the Federal Food, Drug and Cosmetic Act. Discovered during facility inspections and later the subject of a warning letter, these deficiencies were not corrected, despite several notifications from the FDA. Accordingly, the present action was taken against Laclede, as the Company failed to take corrective actions in response to numerous warnings by the FDA. Had the company heeded the repeated warnings posed to them by the FDA and made appropriate changes to the branding of their products, they may have been able to avoid further action. Any company that has received notice regarding the misbranding of products should take appropriate action as soon as possible to reduce the risk of further penalties.

If you have any questions about how you can maintain compliance with FDA regulations, please contact us at contact@sglawfl.com.

The action taken against Ascend Laboratories and Masters Pharmaceuticals (“the Companies”) was taken as a follow up to a November 2013 inspection of Ascend, which found that these products had been marketed in the absence of an FDA-approved drug application. The inspection further found that these products were misbranded and were being sold contrary to the guidance provided by the FDA for the proper labeling and marketing of a drug or cosmetic.

The FDA took action by filing a complaint in the U.S. District Court for the Southern District of Ohio, citing that the Companies violated the provisions of the Federal Food, Drug and Cosmetic Act (“FFDCA”) found in Title 21, Code of Federal Regulations as promulgated under 21 U.S.C. 321 and 387. Under FFDCA and accompanying FDA regulations, products that intended to be used in the diagnosis, cure, treatment or prevention of a disease or condition are considered drugs. As noted in this case, the Companies marketed products for various diseases and/or conditions, including hemorrhoids, colitis and eczema. Further, while the FDA did not allege the products themselves contained active pharmaceutical ingredients, it was the statements made in marketing that caused the products to be deemed unapproved new drugs. Accordingly, it is important to ensure compliance with certain marketing limitations in order to avoid misbranding and other FDA violations.

In sum, this case illustrates the importance of ensuring that the marketing materials of FDA-regulated products, including websites, print media and product labels, are properly worded because statements made in marketing play a key role in determining how FDA-regulated products are regulated. Second, this case illustrates the importance of being responsive and remaining committed to taking all necessary corrective actions after deficiencies are alleged, as the Agency will pursue legal action for violations of the laws and regulations it enforces.

If you have any questions about the FDA’s food, drug and cosmetic regulations or how you can maintain compliance with these regulations, please contact us at contact@sglawfl.com.

Both Afinitor and the newly-approved Afinitor Disperz were both approved through the FDA’s Accelerated Approval Program. Through the Program, drug sponsors are able to obtain expedited approval of drug products that are intended to treat serious diseases in situations where there is an unmet medical need. Though this process is accelerated, drug sponsors are still required to perform studies to confirm that the drug product provides the anticipated clinical benefit. In addition, drug sponsors may be required to perform ongoing studies in order to ensure the long-term safety of drugs approved through this process. In fact, both Afinitor and Afinitor Disperz are subject to these ongoing studies. More information about the FDA’s Accelerated Approval Program may be accessed here.

This week has marked a number of firsts with respect to drug approvals. As we recently reported, on August 27, 2012, the FDA approved a new four-in-one combination pill for the treatment of the HIV-1 infection in adults who have not previously received treatment for the infection. For more information about the FDA approval process or the laws and regulations enforced by the FDA generally, please contact us at contact@sglawfl.com.

In the past, the FDA has issued statements to consumers and industry concerning the presence of undeclared active ingredients in dietary supplements, and with the recent recall it appears that this issue remains a high priority for the FDA. For more information about maintaining compliance with FDA regulations, contact us at contact@sglawfl.com.

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