Is Zhuangge Jianji Protein Tablet Approved by Essential Pharmaceutical Corp? - Pharmacology

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Zhongge Jianji Protein Tablets


I would like to know if this product is compliant (Zhuangge Jianji Protein Tablets) Manufacturer: ESSENTIAL PHARMACEUTICAL CORP.
POMONA, CA 91768 U.S.A.
Distributor: Jingxun International Co., Ltd.
License No.
88018689.

Studend, 10~19 year old female. Ask Date: 2003/02/06

Dr. Chen Yuemei reply Pharmacology


Hello Student: Based on the information you provided, this product should be classified as a food item.
To determine whether this product is compliant, I will address it in two scenarios: 1.
Whether the ingredient content labeling matches the actual content, which can be verified by sending the product to the Food and Drug Administration for testing.
2.
Whether imported food has been inspected and registered by the Department of Health, which only reviews its ingredients, formulation, and source as a basis for customs clearance.
A successful registration will have a "Department of Health Food Number." Essentially, food products do not need to display a so-called "Department of Health Food Number." The status of general food products is the same regardless of whether they have a number; those labeled with a "Department of Health Food Number" simply indicate that the product is classified as food in terms of management.
I have downloaded some information from the Food Information Network for your reference: If you must consume such food products, please pay attention to the following points: 1.
Check for a "Drug Number"; if present, it is a medication, not food.
2.
For tablet or capsule forms, confirm the presence of the word "food." 3.
Ensure there is a complete Chinese label.
4.
Review the ingredient content, brand, manufacturer, etc.
5.
Call the manufacturer to confirm the labeling information, such as the food number and certificates.
You should refuse to purchase if you encounter any of the following situations: 1.
Unknown origin.
2.
No Chinese labeling, unclear or incomplete labeling, such as product name, ingredients, manufacturer name, address, phone number, etc.
3.
Products that claim therapeutic effects or use exaggerated terms, such as super, invincible...
for weight loss, slimming, or enhancing vitality.
4.
Do not trust exaggerated advertisements and promotions.
5.
Products you do not understand, such as the ingredients or the manufacturer's reputation.
In summary, when purchasing such food products, do not casually believe in unverified rumors; seek reputable manufacturers, carefully examine relevant labels and descriptions, and choose based on your health needs.
A more cautious approach is to consult a physician or nutritionist before purchasing to ensure your health is protected.
However, it is important to remind the public that a balanced diet combined with appropriate exercise is the key to maintaining health.

Reply Date: 2003/02/06

More Info


The Zhuangge Jianji Protein Tablet, produced by Essential Pharmaceutical Corp. in Pomona, California, raises questions regarding its compliance and safety as a dietary supplement. To determine whether this product is approved and meets safety standards, we need to consider several factors.

Firstly, it is essential to clarify that the Zhuangge Jianji Protein Tablet is categorized as a dietary supplement rather than a pharmaceutical drug. This distinction is crucial because dietary supplements are regulated differently than medications. In the United States, the Food and Drug Administration (FDA) oversees dietary supplements, but they do not require pre-market approval as they do for prescription medications. Instead, manufacturers are responsible for ensuring that their products are safe and that any claims made about them are not misleading.

To assess the compliance of the Zhuangge Jianji Protein Tablet, we should examine the following aspects:
1. Ingredient Verification: The product's ingredient list should be scrutinized to ensure that it contains what it claims. This can be verified through independent laboratory testing, which can confirm the presence and concentration of active ingredients. Consumers can also check if the product has been tested for contaminants, such as heavy metals or harmful substances.

2. Labeling and Claims: The labeling of dietary supplements must comply with FDA regulations. This includes accurate ingredient listing, appropriate health claims, and disclaimers. If the product makes specific health claims, it should be backed by scientific evidence. Misleading claims can lead to regulatory action.

3. Manufacturing Practices: Essential Pharmaceutical Corp. should adhere to Good Manufacturing Practices (GMP) as outlined by the FDA. This ensures that products are consistently produced and controlled according to quality standards. Consumers can look for certifications or third-party testing that verifies compliance with these practices.

4. Registration and Approval: In some regions, dietary supplements may require registration with local health authorities. In Taiwan, for example, products must have a registration number from the health department, which indicates that they have been evaluated for safety and efficacy. The registration number you mentioned (88018689) should be verified with the relevant health authority to confirm that the product is approved for sale.

5. Consumer Feedback and Reports: It is also beneficial to look at consumer reviews and reports regarding the product. Adverse effects or lack of efficacy reported by users can be a red flag.

In summary, while the Zhuangge Jianji Protein Tablet is produced by a company that is likely compliant with U.S. regulations, consumers should conduct thorough research to ensure the product's safety and efficacy. This includes verifying the ingredient list, checking for proper labeling, ensuring adherence to GMP, and confirming registration with health authorities. Consulting with healthcare professionals, such as doctors or registered dietitians, can also provide personalized advice based on individual health needs and conditions. Ultimately, maintaining a balanced diet and engaging in regular physical activity are fundamental components of health, and supplements should complement, not replace, these practices.

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